amoxicillin-potassium-clavulanate-combination and Acute-Disease

Acute otitis media (AOM) is the inflammation of the middle ear. It constitutes one of the most frequent infections which affects children and usually occurs between 6 to 24 months of age. AOM can emerge due to viruses and/or bacteria. The aim of the current systematic review is to assess in children between 6 months and 12 years of age with AOM, the efficacy of any antimicrobial agent or placebo compared with amoxicillinclavulanate, to measure the resolution of AOM or symptoms.. The medical databases PubMed (MEDLINE) and Web of Science were used. Data extraction and analysis were performed by two independent reviewers. Eligibility criteria were set, and only randomised control trials (RCTs) were included. Critical appraisal of the eligible studies was performed. Pooled analysis was conducted using the Review Manager v. 5.4.1 software (RevMan).. Twelve RCTs were totally included. Three (25.0%) RCTs studied the impact of azithromycin, two (16.7%) investigated the impact of cefdinir, two (16.7%) investigated placebo, three (25.0%) studied quinolones, one (8.3%) investigated cefaclor and one (8.3%) studied penicillin V, compared to amoxicillin-clavulanate. In five (41.7%) RCTs, amoxicillin-clavulanate proved to be superior to azithromycin, cefdinir, placebo, cefaclor and penicillin V, while in seven (58.3%) RCTs its efficacy was comparable with other antimicrobials or placebo. The rates of AOM relapse after treatment with amoxicillin-clavulanate were comparable to those of other antimicrobials or placebo. However, amoxicillin-clavulanate was more effective in eradicating Streptococcus pneumoniae from the culture, when compared to cefdinir. The results of the meta-analysis were not evaluated due to substantial heterogeneity between studies.. Amoxicillin-clavulanate should be the treatment of choice for children between 6 months and 12 years of age with AOM.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin; Cefaclor; Cefdinir; Child; Humans; Infant; Otitis Media; Penicillin V; Treatment Outcome

Pediatric acute bacterial rhinosinusitis (ABRS) is often treated with oral antibiotics, with limited insight into adverse effects (AEs) across drug classes. In this systematic review and meta-analysis, we characterize AE incidence associated with oral antibiotics in these patients.. We searched PubMed and Embase for English-language articles published from 1985 to September 2020 reporting AEs of oral antibiotic therapy for ABRS patients aged 0-18 years. Six-hundred and sixty-six articles underwent title and abstract screening, identifying 154 articles for full-length review.. Eleven articles were included, most of which reported individual and aggregate AE incidences. Amoxicillin/clavulanate, amoxicillin, cephalosporin/carbacephem, and placebo groups were identified. Random-effects meta-analysis of prospective groups identified appreciable incidences of diarrhea and abdominal pain, and low incidence of rash, for amoxicillin-clavulanate and amoxicillin. All antibiotics as well as placebo were associated with non-zero overall AE incidence. Children receiving antibiotics were about twice as likely to incur any AE during treatment in placebo-controlled studies, though this association was not significant. High heterogeneity limited most point estimates, with risk of bias, typically in outcomes measurement, detected in most studies.. Reporting of AEs associated with oral antibiotic use in pediatric ABRS is limited in current literature. Adverse effects are non-negligible, but may not significantly exceed placebo.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Humans; Prospective Studies; Sinusitis

Undifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications.. To assess the effectiveness and safety of antibiotics in preventing bacterial complications in children aged two months to 59 months with undifferentiated ARIs.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1950 to August week 1, 2015) and EMBASE (1974 to August 2015).. Randomised controlled trials (RCTs) or quasi-RCTs comparing antibiotic prescriptions with placebo or no treatment in children aged two months to 59 months with an undifferentiated ARI for up to seven days.. Two review authors independently assessed trial quality and extracted and analysed data using the standard Cochrane methodological procedures.. We identified four trials involving 1314 children. Three trials investigated the use of amoxicillin/clavulanic acid to prevent otitis and one investigated ampicillin to prevent pneumonia.The use of amoxicillin/clavulanic acid compared to placebo to prevent otitis showed a risk ratio (RR) of 0.70 (95% confidence interval (CI) 0.45 to 1.11, three trials, 414 selected children, moderate-quality evidence). Methods of random sequence generation and allocation concealment were not clearly stated in two trials. Performance, detection and reporting bias could not be ruled out in three trials.Ampicillin compared to supportive care (continuation of breastfeeding, clearing of the nose and paracetamol for fever control) to prevent pneumonia showed a RR of 1.05 (95% CI 0.74 to 1.49, one trial, 889 selected children, moderate-quality evidence). The trial was non-blinded. Random sequence generation and allocation concealment methods were not clearly stated, so the possibility of reporting bias could not be ruled out.Harm outcomes could not be analysed as they were expressed only in percentages.We found no studies assessing mastoiditis, quinsy, abscess, meningitis, hospital admission or death.. There is insufficient evidence for antibiotic use as a means of reducing the risk of otitis or pneumonia in children up to five years of age with undifferentiated ARIs. Further high-quality research is needed to provide more definitive evidence of the effectiveness of antibiotics in this population.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Child, Preschool; Humans; Otitis; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Suppuration

Acute rhinosinusitis is one of the most common conditions that physicians treat in ambulatory care. Most cases of acute rhinosinusitis are caused by viral upper respiratory infections. A meta-analysis based on individual patient data found that common clinical signs and symptoms were not effective for identifying patients with rhinosinusitis who would benefit from antibiotics. C-reactive protein and erythrocyte sedimentation rate are somewhat useful tests for confirming acute bacterial maxillary sinusitis. Four signs and symptoms that significantly increase the likelihood of a bacterial cause when present are double sickening, purulent rhinorrhea, erythrocyte sedimentation rate greater than 10 mm per hour, and purulent secretion in the nasal cavity. Although cutoffs vary depending on the guideline, antibiotic therapy should be considered when rhinosinusitis symptoms fail to improve within seven to 10 days or if they worsen at any time. First-line antibiotics include amoxicillin with or without clavulanate. Current guidelines support watchful waiting within the first seven to 10 days after upper respiratory symptoms first appear. Evidence on the use of analgesics, intranasal corticosteroids, and saline nasal irrigation for the treatment of acute rhinosinusitis is poor. Nonetheless, these therapies may be used to treat symptoms within the first 10 days of upper respiratory infection. Radiography is not recommended in the evaluation of uncomplicated acute rhinosinusitis. For patients who do not respond to treatment, computed tomography of the sinuses without contrast media is helpful to evaluate for possible complications or anatomic abnormalities. Referral to an otolaryngologist is indicated when symptoms persist after maximal medical therapy and if any rare complications are suspected.

Topics: Acute Disease; Administration, Intranasal; Adrenal Cortex Hormones; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Blood Sedimentation; C-Reactive Protein; Humans; Maxillary Sinusitis; Nasal Lavage; Rhinitis; Sinusitis; Tomography, X-Ray Computed; Virus Diseases; Watchful Waiting

Acute lower respiratory tract infections (LRTI) range from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Approximately five million people die from acute respiratory tract infections annually. Among these, pneumonia represents the most frequent cause of mortality, hospitalisation and medical consultation. Azithromycin is a macrolide antibiotic, structurally modified from erythromycin and noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).. To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.. We searched CENTRAL (2014, Issue 10), MEDLINE (January 1966 to October week 4, 2014) and EMBASE (January 1974 to November 2014).. Randomised controlled trials (RCTs) and quasi-RCTs, comparing azithromycin to amoxycillin or amoxycillin/clavulanic acid in participants with clinical evidence of an acute LRTI, such as acute bronchitis, pneumonia and acute exacerbation of chronic bronchitis.. The review authors independently assessed all potential studies identified from the searches for methodological quality. We extracted and analysed relevant data separately. We resolved discrepancies through discussion. We initially pooled all types of acute LRTI in the meta-analyses. We investigated the heterogeneity of results using the forest plot and Chi(2) test. We also used the index of the I(2) statistic to measure inconsistent results among trials. We conducted subgroup and sensitivity analyses.. We included 16 trials involving 2648 participants. We were able to analyse 15 of the trials with 2496 participants. The pooled analysis of all the trials showed that there was no significant difference in the incidence of clinical failure on about days 10 to 14 between the two groups (risk ratio (RR), random-effects 1.09; 95% confidence interval (CI) 0.64 to 1.85). A subgroup analysis in trials with acute bronchitis participants showed significantly lower clinical failure in the azithromycin group compared to amoxycillin or amoxyclav (RR random-effects 0.63; 95% CI 0.45 to 0.88). A sensitivity analysis showed a non-significant reduction in clinical failure in azithromycin-treated participants (RR 0.55; 95% CI 0.25 to 1.21) in three adequately concealed studies, compared to RR 1.32; 95% CI 0.70 to 2.49 in 12 studies with inadequate concealment. Twelve trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.95; 95% CI 0.87 to 1.03). The reduction of adverse events in the azithromycin group was RR 0.76 (95% CI 0.57 to 1.00).. There is unclear evidence that azithromycin is superior to amoxycillin or amoxyclav in treating acute LRTI. In patients with acute bronchitis of a suspected bacterial cause, azithromycin tends to be more effective in terms of lower incidence of treatment failure and adverse events than amoxycillin or amoxyclav. However, most studies were of unclear methodological quality and had small sample sizes; future trials of high methodological quality and adequate sizes are needed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Therapy, Combination; Humans; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Treatment Failure

Suppurative parotidis is an uncommon disease in newborns, with limited information available on its pathogenesis and management: approximately 50 cases have been reported in the literature. Diagnosis is based on clinical signs. The predominant organism is Staphylococcus aureus. The administration of empiric antimicrobial therapy is an essential part of the management in very young patients. Prognosis is good and recurrence of the disease is unusual. We describe a 21-day-old newborn who presented with fever and unilateral swelling of the parotid region, and provide a literature review.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Drug Therapy, Combination; Female; Follow-Up Studies; Gentamicins; Humans; Infant, Newborn; Parotitis; Staphylococcal Infections; Suppuration; Ultrasonography

Undifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications.. To assess the effectiveness and safety of antibiotics in preventing complications in children aged two to 59 months with undifferentiated ARIs.. We searched CENTRAL 2013, Issue 4, MEDLINE (1950 to May week 2, 2013) and EMBASE (1974 to May 2013).. Randomised controlled trials (RCT) or quasi-RCTs comparing antibiotic prescriptions with placebo or non-treatment in children up to 59 months with an undifferentiated ARI for up to seven days.. Two review authors independently assessed trial quality and extracted and analysed data using the standard Cochrane methodological procedures.. We identified four trials involving 1314 children. Three trials investigated the use of amoxicillin/clavulanic acid to prevent otitis and one investigated ampicillin to prevent pneumonia.The use of amoxicillin/clavulanic acid compared to placebo to prevent otitis showed a risk ratio (RR) of 0.70 (95% confidence interval (CI) 0.45 to 1.11, three trials, 414 selected children, moderate-quality evidence). Methods of random sequence generation and allocation concealment were not clearly stated in two trials. Performance, detection and reporting bias could not be ruled out in three trials.Ampicillin compared to supportive care (continuation of breastfeeding, clearing of the nose and paracetamol for fever control) to prevent pneumonia showed a RR of 1.05 (95% CI 0.74 to 1.49, one trial, 889 selected children, moderate-quality evidence). The trial was non-blinded. Random sequence generation and allocation concealment methods were not clearly stated so the possibility of reporting bias could not be ruled out.Harm outcomes could not be analysed as they were expressed only in percentages.No studies were found assessing mastoiditis, quinsy, abscess, meningitis, hospital admission or death.. The quality of evidence currently available does not provide strong support for antibiotic use as a means of reducing the risk of otitis or pneumonia in children up to five years of age with undifferentiated ARIs. Further high-quality research is needed to provide more definitive evidence of the effectiveness of antibiotics in this population.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Child, Preschool; Humans; Otitis; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Suppuration

On the basis of strong research evidence, the pathogenesis of sinusitis involves 3 key factors: sinusostia obstruction, ciliary dysfunction, and thickening of sinus secretions. On the basis of studies of the microbiology of otitis media, H influenzae is playing an increasingly important role in the etiology of sinusitis, exceeding that of S pneumoniae in some areas, and b-lactamase production by H influenzae is increasing in respiratory isolates in the United States. On the basis of some research evidence and consensus,the presentation of acute bacterial sinusitis conforms to 1 of 3 predicable patterns; persistent, severe, and worsening symptoms. On the basis of some research evidence and consensus,the diagnosis of sinusitis should be made by applying strict clinical criteria. This approach will select children with upper respiratory infection symptoms who are most likely to benefit from an antibiotic. On the basis of some research evidence and consensus,imaging is not indicated routinely in the diagnosis of sinusitis. Computed tomography or magnetic resonance imaging provides useful information when complications of sinusitis are suspected. On the basis of some research evidence and consensus,amoxicillin-clavulanate should be considered asa first-line agent for the treatment of sinusitis.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Diagnosis, Differential; Humans; Respiratory Tract Infections; Sinusitis; Virus Diseases

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Child; Drug Administration Schedule; Humans; Otitis Media; Randomized Controlled Trials as Topic; Treatment Failure

Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, additional malaise and fever. It affects 1% to 5% of the adult population each year in Europe.. We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with clinically diagnosed acute sinusitis, and in people with radiologically or bacteriologically confirmed acute sinusitis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).. We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.. In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics (amoxicillin, amoxicillin-clavulanic acid [co-amoxiclav], doxycycline, cephalosporins, macrolides; different doses, long-course regimens), antihistamines, decongestants (xylometazoline, phenylephrine, pseudoephedrine), saline nasal washes, steam inhalation, and topical corticosteroids (intranasal).

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Double-Blind Method; Evidence-Based Medicine; Humans; Macrolides; Sinusitis

Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, additional malaise and fever. It affects 1-5% of the adult population each year in Europe.. We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with clinically diagnosed acute sinusitis, and with radiologically or bacteriologically confirmed acute sinusitis? We searched: Medline, Embase, The Cochrane Library and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).. We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.. In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics (amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides, different doses [amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides], long-course regimens), antihistamines, cephalosporins or macrolides, decongestants (xylometazoline, phenylephrine, pseudoephedrine), doxycycline, saline nasal washes, steam inhalation, and topical corticosteroids (intra-nasal).

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Double-Blind Method; Evidence-Based Medicine; Humans; Macrolides; Sinusitis

Acute lower respiratory tract infections (LRTI) range from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Approximately five million people die of acute respiratory tract infections annually. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).. To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007 Issue 2), MEDLINE (January 1966 to July 2007), and EMBASE (January 1974 to July 2007).. Randomized and quasi-randomized controlled trials, comparing azithromycin to amoxycillin or amoxycillin/clavulanic acid in participants with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied.. The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute LRTI were initially pooled in the meta-analyses. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I-square (I(2)) was also used to measure inconsistent results among trials. Subgroup and sensitivity analyses were conducted.. Fifteen trials were analysed. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 between the two groups (relative risk (RR), random-effects 1.09; 95% confidence interval (CI) 0.64 to 1.85). Sensitivity analysis showed a reduction of clinical failure in azithromycin-treated participants (RR 0.55; 95% CI 0.25 to 1.21) in three adequately concealed studies, compared to RR 1.32; 95% CI 0.70 to 2.49 in 12 studies with inadequate concealment. Twelve trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.95; 95% CI 0.87 to 1.03). The reduction of adverse events in the azithromycin group was RR 0.76 (95% CI 0.57 to 1.00).. There is unclear evidence that azithromycin is superior to amoxicillin or amoxyclav in treating acute LRTI. In patients with acute bronchitis of a suspected bacterial cause, azithromycin tends to be more effective in terms of lower incidence of treatment failure and adverse events than amoxicillin or amoxyclav. Future trials of high methodological quality are needed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Therapy, Combination; Humans; Pneumonia; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Treatment Failure

Children attending day care centers (DCCs) frequently carry antibacterial-resistant organisms in their nasopharynx, leading to acute otitis media (AOM) that may be refractory to antibacterial treatment. The development and spread of resistant organisms are facilitated in DCCs as a result of the following: (i) large numbers of children; (ii) frequent close person-to-person contact; and (iii) a wide use of antimicrobial medications. Intensive antimicrobial usage provides the selection pressure that favors the emergence of resistant organisms, while DCCs provide an ideal environment for transmission of these organisms. The American Academy of Pediatrics and American Academy of Family Physicians' guidelines recommend high-dose amoxicillin/clavulanic acid (rather than amoxicillin alone) as the first therapeutic choice in the treatment of AOM in children attending DCCs. The introduction of the 7-valent pneumococcal conjugated vaccine (PCV7) had a major role in decreasing the number of episodes of Streptococccus pneumoniae AOM secondary to the serotypes included in the vaccine. It also had a major role in reducing the nasopharyngeal carriage of vaccine-type S. pneumoniae (and in particular of antibacterial-resistant organisms), preventing, in this way, its spread to contacts in the community. However, the recent observation of increased rates of antibacterial-resistant non-vaccine serotype S. pneumoniae may erode the success of PCV7.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child Day Care Centers; Child, Preschool; Drug Resistance, Bacterial; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Infant; Infant, Newborn; Meningococcal Vaccines; Otitis Media; Pharynx; Pneumococcal Infections; Pneumococcal Vaccines; Practice Guidelines as Topic; Streptococcus pneumoniae

To compare the efficacy and tolerability of a 5-day course of telithromycin (800 mg once daily) with a 10-day course of telithromycin or standard comparators (amoxicillin-clavulanate 500/125 mg three times daily or cefuroxime axetil 250 mg twice daily) in patients with acute maxillary sinusitis (AMS).. Data from three randomised double blind studies were pooled. The studies included patients with clinical symptoms of AMS and sinus X-ray findings of total opacity, air-fluid levels or mucosal thickening.. Pooled analysis of results for 5-day telithromycin revealed overall clinical cure rates of 83.6% (383/458 patients) at post-therapy (days 17-24) and 78.9% (330/418 patients) at late post-therapy (days 31-45) in the per-protocol population. Clinical cure rates at post-therapy were equivalent to those observed with 10-day telithromycin (82.5% vs 81.7%) or comparator treatment (80.9% vs 77.4%). Moreover, clinical cure rates exceeded 80% in subgroups of patients of interest, including those with severe infection and those fulfilling more stringent criteria for bacterial AMS. A satisfactory bacteriological outcome was achieved in 87.6% of patients. The 5-day telithromycin regimen was well tolerated.. Telithromycin once daily for 5 days offers effective treatment for AMS and is comparable to 10-day courses of standard treatments.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Ketolides; Male; Maxillary Sinusitis; Middle Aged

To determine whether guidelines relating to the diagnosis and treatment of acute otitis media (AOM) in children are followed in a tertiary paediatric emergency department (ED).. A literature search was undertaken to identify national and international guidelines relating to the diagnosis and management of AOM in children. The guidelines were assessed for their applicability to UK practice. A retrospective case note audit was undertaken. Children presenting to the ED with a discharge diagnosis of AOM over a two month period were identified from the ED computer discharge system. The notes were analysed for compliance with the identified guidelines.. 50 children were identified (age range three months to 11 years). Eighty-six per cent of children received antibiotics. Fifty-two per cent of children had documented signs of AOM. Twenty-five of these children received antibiotics (22 in accordance with guidelines, three not in accordance with guidelines, antibiotic not documented in one case). Thirty-nine per cent of children received antibiotics inappropriately. In all cases, the antibiotic dosage was below the dose recommended in all guidelines.. There is poor compliance with national (and international) guidelines for the management of AOM in this ED. National guidelines must be introduced into the department by direct teaching at senior house officer and middle grade level, a re-audit must be carried out and regular reviews of the notes of patients diagnosed with AOM must be undertaken to ensure compliance with guidelines is maintained.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Emergency Medical Services; Guideline Adherence; Humans; Infant; Medical Audit; Otitis Media; Practice Guidelines as Topic; Retrospective Studies; Risk Factors; United Kingdom

Telithromycin, the first approved ketolide antibiotic, was developed to treat community-acquired respiratory tract infections, including acute bacterial maxillary sinusitis (ABMS). A previously published study showed that a 5-day course of 800 mg telithromycin once daily is as effective as a 10-day course in the treatment of ABMS.. Data were pooled from two controlled, multinational, prospective, randomized, double-blinded ABMS trials comparing 5-day telithromycin (800 mg once daily) with 10-day amoxicillin-clavulanate (500/125 mg 3 times daily) and cefuroxime axetil (250 mg twice daily). Clinical cure and bacteriologic eradication rates were compared by means of descriptive statistics.. The clinical cure rate for telithromycin was 80.9% versus 77.4% for comparators; bacteriologic eradication rate for telithromycin was 84.9% versus 81.7% for comparators. Most adverse events were mild to moderate in intensity and, most commonly, gastrointestinal in nature.. These results support the conclusion that 5 days of treatment with telithromycin is as safe and effective in patients with ABMS as a 10-day course of treatment with amoxicillin-clavulanate or cefuroxime axetil.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Double-Blind Method; Drug Administration Schedule; Female; Haemophilus influenzae; Humans; Ketolides; Male; Maxillary Sinusitis; Middle Aged; Moraxella catarrhalis; Prospective Studies; Randomized Controlled Trials as Topic; Staphylococcus aureus; Streptococcus pneumoniae

Acute bacterial rhinosinusitis (ABRS) is a secondary bacterial infection of the nose and paranasal sinuses, usually preceded by a viral upper respiratory infection or allergy, with symptoms that have not improved after 10 days or that have worsened after 5 to 7 days. Streptococcus pneumoniae and Haemophilus influenzae are the most common causes of ABRS in adults. Increasing rates of antimicrobial resistance among S. pneumoniae and beta-lactamase production among H. influenzae are formidable challenges to the successful treatment of infections caused by these organisms. To this end, various formulations of amoxicillin-clavulanate have been developed, the most recent of which is pharmacokinetically enhanced and provides a total daily dose of 4,000 mg of amoxicillin and 250 mg of clavulanate. This formulation has been shown to be safe and effective in the treatment of infections caused by penicillin-resistant S. pneumoniae (minimum inhibitory concentration 2 microg/mL); the clavulanate component provides adequate coverage of beta-lactamase-producing pathogens.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Haemophilus influenzae; Humans; Penicillin Resistance; Pneumococcal Infections; Rhinitis; Sinusitis; Streptococcus pneumoniae

The spectrum of acute lower respiratory tract infection ranges from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Annually approximately five million people die of acute respiratory tract infections. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and is noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae).. To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2003), MEDLINE (January 1966 to January Week 3, 2004), and EMBASE (January 1988 to 2003).. Randomised and quasi-randomised controlled trials, which compared azithromycin to amoxycillin or amoxycillin/clavulanic acid in patients with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied.. The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute lower respiratory tract infections were initially pooled in the meta-analyses. Funnel plot was used to examine publication bias. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I(2) was also used to measure inconsistency results among trials. Subgroup analysis was conducted for age, types of respiratory tract infection and types of antibiotic in control groups. Sensitivity analysis was conducted under the condition of trial size and concealment of treatment allocation.. Fourteen trials with 2,521 enrolled patients used 2,416 patients in the analysis. A total of 1,350 patients received azithromycin and 1,066 received amoxicillin or amoxicillin-clavulanic acid. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 after therapy started between the two groups (relative risk (RR) (random effects) 0.96; 95% CI 0.58 to 1.57). Sensitivity analysis showed that a reduction of clinical failure in azithromycin-treated patients (RR 0.52; 95% CI 0.24 to 1.12) in three adequately concealed studies, compared to RR 1.14 (95% CI 0.62 to 2.08) in eleven studies with inadequate concealment. Eleven trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.98; 95% CI 0.91 to 1.07). The reduction of adverse events in azithromycin group was RR 0.75 (95% CI 0.56 to 1.00).. There is unclear evidence that azithromycin is superior to amoxicillin or amoxicillin-clavulanic acid in treating acute LRTI. Future trials with high methodological quality are needed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bronchitis; Drug Therapy, Combination; Humans; Pneumonia; Randomized Controlled Trials as Topic; Treatment Failure

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cephalosporins; Humans; Sinusitis

Amoxicillin/clavulanic acid (Augmentin), Augmentin ES-600 is a well established, orally administered combination of amoxicillin (a semisynthetic antibacterial agent) and clavulanic acid (a beta-lactamase inhibitor). Amoxicillin/clavulanic acid shows good activity against the main pathogens associated with acute otitis media (AOM), including penicillin-susceptible and -intermediate strains of Streptococcus pneumoniae, and beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. It has moderate activity against penicillin-resistant S. pneumoniae; a high-dose formulation has been developed with the aim of providing better coverage for penicillin-resistant strains. Amoxicillin/clavulanic acid (conventional formulations, mostly 40/10 mg/kg/day in three divided doses) produced clinical response rates similar to those of oral cephalosporin comparators and similar to or significantly greater than those for intramuscular ceftriaxone in randomised trials in paediatric patients with AOM (mean age approximately 2 to 5 years). Clinical response rates were generally similar for amoxicillin/clavulanic acid and macrolide comparators (mean patient age approximately 1 to 6 years), although significantly better clinical and bacteriological responses were seen versus azithromycin in one randomised trial (mean patient age approximately 1 year). The high-dose formulation of amoxicillin/clavulanic acid (90/6.4 mg/kg/day in two divided doses) eradicated a high proportion of penicillin-resistant S. pneumoniae (penicillin MICs 2 or 4 mg/L) in a large noncomparative trial in children with AOM (upper limit of the US indication for S. pneumoniae is 2 mg/L). Amoxicillin/clavulanic acid is generally well tolerated. A low total incidence of adverse events (3.6%) and no serious events were reported from a large paediatric postmarketing study. The most frequently reported adverse events in children are mild gastrointestinal disturbances. Diarrhoea is generally less frequent with twice-daily than with three-times-daily treatment. The new high-dose formulation showed similar tolerability to a conventional twice-daily formulation (45/6.4 mg/kg/day) in a well controlled trial.. Amoxicillin/clavulanic acid is a well established broad-spectrum antibacterial treatment which is effective and well tolerated in the treatment of AOM in paediatric patients. The high-dose combination should prove valuable in treating AOM caused by penicillin-intermediate and -resistant S. pneumoniae (approved in the US for penicillin MIC < or =2 mg/L). Based on recent recommendations and the available data, high-dose amoxicillin/clavulanic acid can be considered a treatment of choice for recurrent or persistent paediatric AOM (after failure of amoxicillin alone) where involvement of resistant pathogens is suspected.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Humans; Microbial Sensitivity Tests; Otitis Media

Community-acquired bacterial respiratory tract infections are among the most common health disorders requiring medical care and are associated with substantial morbidity, mortality, and direct and indirect costs. Recent increases in the prevalence of antimicrobial resistance have resulted in reduced susceptibility of the most common respiratory tract bacterial pathogens to a number of antimicrobials. Amoxicillin/clavulanate potassium extended release (ER) tablets (Augmentin XR, GlaxoSmithKline) is a new formulation of amoxicillin/clavulanate that retains activity against betalactamase-producing organisms whilst increasing the activity against Streptococcus pneumoniae through elevated and sustained plasma amoxicillin concentrations. The bilayer tablet provides immediate release of clavulanate and both immediate and sustained release of amoxicillin to maintain therapeutic concentrations of amoxicillin over longer periods of the dosing interval. In clinical trials of acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP), amoxicillin/clavulanate ER was shown to have excellent bacteriological and clinical success rates, even in patients infected with antimicrobial-resistant pathogens, and was found to be generally well tolerated. Amoxicillin/clavulanate ER is approved in the US for the treatment of patients with ABS or CAP caused by beta-lactamase-producing pathogens (ie, Haemophilus influenzae, Moraxella catarrhalis, Haemophilus parainfluenzae, Klebsiella pneumoniae, or methicillin-susceptible Staphylococcus aureus) and S. pneumoniae with reduced susceptibility to penicillin (penicillin minimum inhibitory concentration = 2.0 microg/ml).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clinical Trials as Topic; Community-Acquired Infections; Delayed-Action Preparations; Humans; Pneumonia; Sinusitis; Tablets, Enteric-Coated

Chemical synthesis of the penicillin nucleus in the 1950s made introduction of a broad array of new and important antimicrobials, including ampicillin and amoxicillin, possible. Ampicillin was introduced in 1962 in oral and parenteral forms as the first of the semisynthetic penicillins to provide increased activity against Gram-negative bacteria. Amoxicillin replaced oral ampicillin beginning in 1974 because amoxicillin resulted in higher and more prolonged serum concentrations than did equivalent doses of ampicillin. Amoxicillin/clavulanate (Augmentin) was introduced in the United States in 1984 to enhance the activity of amoxicillin by addition of the beta-lactamase inhibitor, clavulanic acid. During the past 20 years, amoxicillin/clavulanate has proven effective for a variety of pediatric infectious diseases, particularly acute otitis media (AOM). In 2001, a new pediatric formulation, high dose amoxicillin/clavulanate (Augmentin ES-600) was approved for use in the United States. The high dose preparation addressed the needs of pediatricians by providing greater amounts of amoxicillin while maintaining the same daily dose of clavulanic acid as the regular strength formulation. Doubling the dose of amoxicillin for management of recurrent and persistent AOM was recommended in 1999 by the Centers for Disease Control and Prevention because of concern about the increased incidence of nonsusceptible strains of Streptococcus pneumoniae. The original formulation combined amoxicillin/clavulanate in a 4:1 ratio and was followed by a 7:1 ratio formulation. The high dose formulation (600 mg of amoxicillin per 5 ml) provides a 14:1 ratio of amoxicillin to clavulanate. Although management of AOM will likely undergo changes in the coming years, amoxicillin is expected to remain first line therapy for AOM. For children who fail initial therapy with amoxicillin, high dose amoxicillin/clavulanate, an oral cephalosporin or parenteral ceftriaxone is recommended.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Resistance, Bacterial; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Moraxella catarrhalis; Otitis Media; Streptococcus pneumoniae

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cephalosporins; Humans; Macrolides; Sinusitis

The major problems encountered in the antibiotic therapy of acute otitis media (AOM) are the tremendous increase in the resistance to antibiotics of its main pathogens and the lack of tight criteria (taking into consideration, as a major determinant, the eradication of the pathogens from the middle ear fluid) in the selection of the appropriate antibiotic drugs for the treatment of this disease. Future drugs for the treatment of AOM will have to be approved only after their in vivo microbiological efficacy for each major pathogen is documented. This documentation will be provided by more antibiotic studies with bacteriological outcome using the double-tympanocentesis method and stratifying the AOM patients by age and initial clinical severity. Judicious use of antibiotics for the treatment of AOM will have a major impact on society, leading to a less frequent but more skilled administration of the most effective drugs.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Cephalosporins; Drug Resistance, Microbial; Humans; Macrolides; Otitis Media; Trimethoprim, Sulfamethoxazole Drug Combination

The authors report a case of Lemierre's syndrome. This uncommon clinical entity is characterized by a septic internal jugular vein thrombosis with secondary metastatic abscesses and Fusobacterium necrophorum septicemia, following an acute oropharyngeal infection. The diagnosis is primarily clinical and it should be suspected when a severe septicaemic illness, with pulmonary symptoms, occurs after an acute pharyngotonsillar infection. This article reviews the clinical picture, microbiology and treatment of this forgotten complication of acute tonsillitis.

Topics: Abscess; Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Angina Pectoris; Anti-Bacterial Agents; Anticoagulants; Clindamycin; Drug Therapy, Combination; Female; Fusobacterium Infections; Fusobacterium necrophorum; Heparin; Humans; Jugular Veins; Metronidazole; Pharyngitis; Sepsis; Syndrome; Thrombosis; Tonsillitis; Ultrasonography, Doppler

Amoxicillin/clavulanic acid is a widely used antibiotic. Hepatic dysfunction is a rare adverse reaction associated with this combination antibiotic. We report the case of a 40-yr-old woman with a somewhat unusual presentation of amoxicillin/clavulanate-related cholestatic hepatotoxicity and multiple duodenal erosions whose diagnosis was delayed until inadvertent rechallenge with the antibiotic combination. The relevant literature is also reviewed and discussed. The diagnosis may be missed because the onset of signs/symptoms may occur several weeks after the cessation of therapy. The hepatic dysfunction, which may be severe and is more prevalent in elderly patients, is usually reversible, although chronic liver disease and deaths have been reported. Immunological hypersensitivity is considered to be the most likely mechanism resulting in liver injury. Amoxicillin/clavulanate should be used with caution in patients with underlying liver disease and in the elderly.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Chemical and Drug Induced Liver Injury; Cholestasis; Drug Therapy, Combination; Female; Humans; Recurrence; Sinusitis

Although it varies from country to country, there is a worrying worldwide increase in antibiotic resistance among pathogens causing otitis. This has led to a search for therapeutic alternatives to the reference treatment, which is still amoxicillin in many countries. Cefpodoxime proxetil is one such alternative. Six comparative randomized trials of cefpodoxime proxetil in childhood acute otitis media have been published or presented at international conferences. They involved a total of 1188 patients, 658 of whom received cefpodoxime proxetil and 530 of whom received the comparator drug (amoxicillin/clavulanic acid in 3 trials, cefaclor in 1, and cefixime in 2); duration of treatment varied from 5 days for cefpodoxime proxetil to 10 days for amoxicillin/clavulanic acid, and the age of the children included ranged from 2 months to 12 years. The clinical efficacy of cefpodoxime proxetil was at least equivalent to that of the comparators in 4 trials and significantly better in 2 trials. Firstly, in one study vs. amoxicillin/clavulanic acid, the superiority of cefpodoxime proxetil (8 mg/kg/day twice daily) in terms of healing at the end of treatment and in terms of the number of normal tympanograms at the follow-up visit was shown. Secondly, in a study performed by our group, vs. cefixime, cefpodoxime proxetil (8 mg/kg/day twice daily) showed a better healing rate at the end of treatment in febrile and painful acute otitis media. The microbiologic and pharmacokinetic data show that cefpodoxime proxetil is one of the most active compounds against Haemophilus influenzae and Streptococcus pneumoniae.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Prodrugs; Randomized Controlled Trials as Topic; Streptococcus pneumoniae; Treatment Outcome

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

In two randomized clinical trials in children with otitis media, the efficacy and safety of cefprozil are compared to those of amoxicillin/clavulanate (n = 530) and of cefaclor and cefixime (n = 394). The rate of clinical cure or improvement was similar among patients receiving each drug regimen, ranging from 78% for amoxicillin/clavulanate to 89% for cefaclor; for cefprozil, this rate was 84% and 85% in the two studies, respectively. In the first study, cefprozil was superior to amoxicillin/clavulanate in the satisfactory clinical response rate for Streptococcus pneumoniae (P = .049), but response rates were similar for Haemophilus influenzae and Moraxella catarrhalis. Significantly more patients treated with amoxicillin/clavulanate (P less than .001) in the first study or cefixime (P less than .01) in the second study developed diarrhea than did those treated with cefprozil. We conclude that cefprozil therapy for otitis media in children produces clinical and bacteriologic response rates similar to those seen with amoxicillin/clavulanate, cefixime, or cefaclor. Furthermore, diarrhea was significantly less common with cefprozil than with cefixime or amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion

A regimen of cefprozil (500 mg twice daily), a new oral cephalosporin with a broad in vitro spectrum of antimicrobial activity, was compared to standard regimens of cefaclor (500 mg three times daily), cefuroxime axetil (500 mg twice daily), or amoxicillin/clavulanate (500 mg/125 mg three times daily) for the treatment of lower respiratory tract infections (mainly bronchitis and acute exacerbations of chronic bronchitis) in adults in three open-label, randomized trials. In the first trial, in which bacterial pathogens were isolated in initial cultures for only one-third of the patients, 90% of the pathogens were susceptible to cefprozil. A satisfactory clinical response was noted for 84% of the evaluable patients who received cefprozil versus 79% of those who received cefaclor for treatment of lower respiratory tract infections; rates of bacteriologic efficacy were 82% and 78%, respectively. In the second study rates of satisfactory clinical response were 96% with cefprozil and 83% with cefuroxime axetil (P less than .03) for treatment of bronchitis; the respective bacteriologic response rates were 100% and 92%. In the third trial, clinical efficacy was 91% for cefprozil and 87% for amoxicillin/clavulanate for treatment of bronchitis; bacteriologic efficacy was 95% and 96%, respectively. Tolerability and safety profiles were comparable, except that there was a higher rate of diarrhea among patients who received amoxicillin/clavulanate (P = .03).

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Bronchopneumonia; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Humans; Pneumonia, Pneumococcal

Two controlled clinical trials compared loracarbef (LY163892 with amoxicillin/clavulanate or amoxicillin in the treatment of acute exacerbations of chronic bronchitis. Collectively, of 1,057 patients enrolled, 390 qualified for analysis: group 1 comprised 200 patients treated with loracarbef (400 mg twice daily); group 2, 120 patients treated with amoxicillin/clavulanate (500 mg three times daily); and group 3, 70 patients treated with amoxicillin (500 mg three times daily). Symptomatic and bacteriologic outcomes were assessed at post-therapy (within 72 hours of therapy completion), and at late-posttherapy (10-14 days after therapy completion). These evaluations were combined to provide an "overall" evaluation that accounted for all unfavorable outcomes occurring at either the posttherapy or late-posttherapy visit. At the posttherapy evaluation, 93.0% of group 1 patients, 95.0% of group 2 patients, and 88.6% of group 3 patients demonstrated favorable clinical outcomes (cure or improvement). "Overall" favorable clinical outcomes were achieved in 88.0% of group 1 patients, 90.0% of group 2 patients, and 81.4% of group 3 patients. Bacteriologic results from the two studies could not be merged due to marked differences in how posttherapy bacteriologic results were assessed. The clinical significance of positive posttherapy sputum cultures was doubtful: 90% of patients with a positive sputum culture at the posttherapy visit who returned for the late-posttherapy visit had successful clinical outcomes documented at the late-posttherapy evaluation. Loracarbef was associated with a lower incidence of diarrhea and a higher incidence of headache as compared with amoxicillin/clavulanate. These results suggest that 400 mg loracarbef twice daily for 7 days is effective and safe in the treatment of acute exacerbations of chronic bronchitis.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cephalosporins; Chronic Disease; Clavulanic Acids; Diarrhea; Drug Therapy, Combination; Europe; Female; Headache; Humans; Incidence; Male; Middle Aged; Treatment Outcome; United States

The choice of antibiotics to be prescribed in otitis media may be guided by microbiological culture of the middle ear exudate obtained by tympanocentesis, or by direct examination and culture of purulent material obtained by myringotomy after rupture of the tympanic membrane. Otherwise, routine antibiotic prescription is based on the epidemiological frequencies of bacteria such as Streptococcus pneumoniae, Hoemophilus influenza or Strepcococcus A. In children who have infrequently received beta-lactam antibiotics, amoxicillin 50-75 mg/kg/day for 10 days may be the first choice. Children who suffer from recurrent episodes of acute otitis media may benefit from one of the three following prescriptions: amoxicillin + clavulanate (Augmentin), or an oral cephalosporin, or the erythromycin + sulfisoxazole combination (Pediazole). If recurrences are frequent and at short intervals, antibiotic prophylaxis may be effective, using penicillin V (Oracillin) 250,000 IU daily throughout the entire cold period.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Clavulanic Acids; Humans; Hypoglycemic Agents; Otitis Media; Recurrence

Young children with acute otitis media (AOM) frequently exhibit nasopharyngeal colonization with either Streptococcus pneumoniae, Haemophilus influenzae or both pathogens. We aimed to determine if antibiotics could be spared or shortened in those without nasopharyngeal colonization with either pathogen.. In 2 separate randomized clinical trials in children aged 6-23 months with stringently-diagnosed AOM, we performed bacterial cultures on nasopharyngeal specimens collected at the time of diagnosis. In the first trial, we compared the efficacy of amoxicillin/clavulanate (amox/clav) administered for 10 days vs. that of placebo, and in the second trial, we compared the efficacy of amox/clav administered for 10 days vs. 5 days. In each trial, we classified children as being colonized with both S. pneumoniae and H. influenzae, S. pneumoniae alone, H. influenzae alone, or neither pathogen, and as experiencing either clinical success or clinical failure at the end-of-therapy visit, based on previously reported a priori criteria.. We evaluated 796 children. Among children randomized to amox/clav, those colonized with either S. pneumoniae or H. influenzae or both were approximately twice as likely to experience clinical failure as children not colonized with either pathogen (odds ratio: 1.8; confidence intervals: 1.2-2.9). In contrast, among children randomized to placebo, clinical failure at the end-of-therapy visit was not associated with nasopharyngeal culture results at the time of diagnosis.. Children colonized with either S. pneumoniae or H. influenzae or both have a greater chance of treatment failure than children colonized with neither pathogen.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Haemophilus influenzae; Humans; Infant; Nasopharynx; Otitis Media; Streptococcus pneumoniae; Treatment Failure

Acute otitis media (AOM) is the most frequent reason for children to be prescribed antimicrobial treatment. Surfactants are naturally occurring substances that may restore the eustachian tube's function and potentially enhance resolution of AOM.. This was a phase 2a, single-center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antimicrobial agents for treating AOM in young children. We randomly assigned 103 children aged 6 to 24 months with AOM to receive either OP0201 or placebo twice daily for 10 days. All children received amoxicillin-clavulanate 90/6.4 mg/kg per day in 2 divided doses for 10 days. Participants were managed for up to 1 month. Postrandomization visits occurred between days 4 and 6 (visit 2), days 12 and 14 (visit 3), and days 26 and 30 (visit 4). Primary efficacy endpoints were resolution of a bulging tympanic membrane at visit 2 and resolution of middle-ear effusion at visit 3.. No clinically meaningful differences between treatment groups were apparent for primary or secondary endpoints. There were no safety concerns identified.. In young children with AOM, intranasally administered surfactant (OP0201) did not improve clinical outcomes. Further research may be warranted among children with persistent middle-ear effusion.

Topics: Acute Disease; Administration, Intranasal; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Surface-Active Agents

Acute otitis media (AOM) induces middle-ear effusion (MEE), which affects hearing. The effect of antimicrobial treatment on the resolution of MEE is controversial, and the factors that affect resolution are unknown.. We studied the effect of antimicrobial treatment on the time to the resolution of MEE as a secondary objective in our randomized double-blind placebo-controlled trial. Children aged 6 to 35 months with stringently diagnosed AOM were allocated to receive amoxicillin-clavulanate (161 patients) or placebo (158 patients) for 7 days and closely followed for 3 months. This study was registered at ClinicalTrials.gov (identifier NCT00299455).. The median times to resolution of MEE were 20 days (95% confidence interval [CI], 16-24 days) and 29 days (95% CI, 26-32 days) in the amoxicillin-clavulanate and placebo groups, respectively (P = .10). The resolution of MEE was confirmed in 138 (86%) of 161 and 132 (84%) of 158 patients in the amoxicillin-clavulanate and placebo groups, respectively (P = .59). In multivariable analysis, the resolution of MEE was prolonged most significantly by at least 1 recurrence of AOM during follow-up. MEE resolved in 65 (65%) of 100 patients with a recurrence of AOM during follow-up and in 205 (94%) of 219 of those without a recurrence (P < .001) (median times to resolution, 67 vs 15 days, respectively; P < .001).. Immediate antimicrobial treatment of AOM does not significantly affect the resolution of MEE in young children. Subsequent recurrences of AOM are a major reason for the persistence of MEE.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Otitis Media with Effusion; Remission Induction

The recommended treatment for acute bacterial sinusitis in adults, amoxicillin with clavulanate, provides only modest benefit.. To see if a higher dose of amoxicillin will lead to more rapid improvement.. Double-blind randomized trial in which, from November 2014 through February 2017, we enrolled 315 adult outpatients diagnosed with acute sinusitis in accordance with Infectious Disease Society of America guidelines.. Standard-dose (SD) immediate-release (IR) amoxicillin/clavulanate 875 /125 mg (n = 159) vs. high-dose (HD) (n = 156). The original HD formulation, 2000 mg of extended-release (ER) amoxicillin with 125 mg of IR clavulanate twice a day, became unavailable half way through the study. The IRB then approved a revised protocol after patient 180 to provide 1750 mg of IR amoxicillin twice a day in the HD formulation and to compare Time Period 1 (ER) with Time Period 2 (IR).. The primary outcome was the percentage in each group reporting a major improvement-defined as a global assessment of sinusitis symptoms as "a lot better" or "no symptoms"-after 3 days of treatment.. Major improvement after 3 days was reported during Period 1 by 38.8% of ER HD versus 37.9% of SD patients (P = 0.91) and during Period 2 by 52.4% of IR HD versus 34.4% of SD patients, an effect size of 18% (95% CI 0.75 to 35%, P = 0.04). No significant differences in efficacy were seen at Day 10. The major side effect, severe diarrhea at Day 3, was reported during Period 1 by 7.4% of HD and 5.7% of SD patients (P = 0.66) and during Period 2 by 15.8% of HD and 4.8% of SD patients (P = 0.048).. Adults with clinically diagnosed acute bacterial sinusitis were more likely to improve rapidly when treated with IR HD than with SD but not when treated with ER HD. They were also more likely to suffer severe diarrhea. Further study is needed to confirm these findings.. ClinicalTrials.gov Identifier: NCT02340000.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Drug Resistance, Microbial; Female; Humans; Male; Medication Adherence; Middle Aged; Sinusitis; Treatment Outcome; Vaginitis

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Infant; Male; Otitis Media; United States

Antimicrobial treatment is effective in the management of acute otitis media (AOM), but approximately half of the children may recover without antimicrobial agents. By identifying patients who may not require antimicrobial treatment for the management of AOM, the use of antimicrobial agents could be substantially reduced. Our aim was to identify subgroups of children with AOM who would benefit most from antimicrobial treatment and children who could be suitable for initial observation.. Treatment failure occurred in 31.7% of all children. Older age (24-35 months) and peaked tympanogram at entry decreased the hazard for treatment failure (hazard ratio, 0.53; 95% confidence interval [CI], 0.29 to 0.96;. Children with severe bulging of the tympanic membrane seem to benefit most from antimicrobial treatment of AOM. On the other hand, children with peaked tympanogram (A and C curves) may be optimal candidates for initial observation.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Otitis Media; Prognosis; Treatment Failure; Tympanic Membrane

The management of acute exacerbation of chronic rhinosinusitis (AECRS) is still under debate, especially because there are no adequate studies to support a best-evidence treatment for this condition. Antibiotic use for AECRS has been recommended based on extrapolation of data from acute rhinosinusitis (ARS) or non-placebo-controlled studies. This study aimed to evaluate whether antibiotic therapy modifies the course of AECRS in a randomized, placebo-controlled study.. Patients with AECRS were randomized in a double-blinded manner (2:1 ratio) to receive either amoxicillin-clavulanate 875 mg/125 mg twice daily (BID) (AMX-CLAV, n = 21) or placebo capsules (n = 11) during 14 days. All patients were also treated with mometasone furoate and nasal washes with saline. Global sinonasal symptoms (Severity Symptom Assessment [SSA]), quality of life (22-item Sino-Nasal Outcome Test [SNOT-22]), nasal endoscopic score (Lund-Kennedy), and microbiological evaluation were compared to evaluate the efficacy of antibiotic therapy in AECRS.. Despite the majority of bacteria cultured from the middle meatus swab were sensitive for AMX-CLAV (84%), both AMX-CLAV and placebo-treated groups presented the same clinical course, with no difference between groups. Both groups exhibited overall improvement of symptoms on day 14 compared to day 0 (p < 0.01), especially the items "nasal secretion" and "nasal obstruction" (p < 0.05). We also observed the same evolution of nasal endoscopic and quality of life scores between placebo and AMX-CLAV.. We concluded that AMX-CLAV for 14 days did not change the clinical course of AECRS compared with placebo. The addition of an oral antibiotic to ongoing topical intranasal steroid spray may not provide additional benefit during management of AECRS.

Topics: Acute Disease; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Bacteria; beta-Lactamase Inhibitors; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Nasal Cavity; Quality of Life; Rhinitis; Sinusitis; Young Adult

Antibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis.. Patients with CT-proven, primary, left-sided, uncomplicated, acute diverticulitis were included at 22 clinical sites in the Netherlands, and assigned randomly to an observational or antibiotic treatment strategy. The primary endpoint was time to recovery during 6 months of follow-up. Main secondary endpoints were readmission rate, complicated, ongoing and recurrent diverticulitis, sigmoid resection and mortality. Intention-to-treat and per-protocol analyses were done.. A total of 528 patients were included. Median time to recovery was 14 (i.q.r. 6-35) days for the observational and 12 (7-30) days for the antibiotic treatment strategy, with a hazard ratio for recovery of 0·91 (lower limit of 1-sided 95 per cent c.i. 0·78; P = 0·151). No significant differences between the observation and antibiotic treatment groups were found for secondary endpoints: complicated diverticulitis (3·8 versus 2·6 per cent respectively; P = 0·377), ongoing diverticulitis (7·3 versus 4·1 per cent; P = 0·183), recurrent diverticulitis (3·4 versus 3·0 per cent; P = 0·494), sigmoid resection (3·8 versus 2·3 per cent; P = 0·323), readmission (17·6 versus 12·0 per cent; P = 0·148), adverse events (48·5 versus 54·5 per cent; P = 0·221) and mortality (1·1 versus 0·4 per cent; P = 0·432). Hospital stay was significantly shorter in the observation group (2 versus 3 days; P = 0·006). Per-protocol analyses were concordant with the intention-to-treat analyses.. Observational treatment without antibiotics did not prolong recovery and can be considered appropriate in patients with uncomplicated diverticulitis. Registration number: NCT01111253 (http://www.clinicaltrials.gov).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Colon, Sigmoid; Diverticulitis, Colonic; Female; Humans; Length of Stay; Male; Middle Aged; Netherlands; Patient Readmission; Recovery of Function; Tomography, X-Ray Computed; Visual Analog Scale; Watchful Waiting

Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.

Topics: Acetylcysteine; Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Free Radical Scavengers; Humans; Male; Nasal Decongestants; Paranasal Sinuses; Pseudoephedrine; Sinusitis; Sodium Chloride; Surveys and Questionnaires; Tomography, X-Ray Computed

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Ciprofloxacin; Conservative Treatment; Diverticulitis, Colonic; Drug Administration Schedule; Drug Hypersensitivity; Drug Substitution; Female; Guideline Adherence; Humans; Infusions, Intravenous; Male; Metronidazole; Middle Aged; Netherlands; Tomography, X-Ray Computed; Treatment Outcome

Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.. We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms.. Children who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P=0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P=0.001). The percentage of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment was lower in the 5-day group than in the 10-day group (181 of 227 children [80%] vs. 211 of 233 [91%], P=0.003). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001).. Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Haemophilus influenzae; Humans; Infant; Male; Nasopharynx; Otitis Media; Prognosis; Streptococcus pneumoniae; Treatment Failure

Intranasal corticosteroids (INS) have been proven effective in controlling postnasal drip, decreasing inflammatory response, reducing nasal swelling, and increasing aeration of the sinuses such that INS are recommended as treatment of sinusitis.. Fifty children with acute rhinosinusitis, 50 children with acute rhiniosinusitis and allergic rhinitis (AR), and 20 rhiniosinusitis children as control were selected for investigation. Each group had a single-blind treatment of three types: with coamoxiclav only, with coamoxiclav plus INS, and with matched placebo (without antibiotics and INS) for two weeks. Nasal symptoms were then evaluated. The outcome was measured by using major symptom score (MSS) after treatment for 14 days.. Therapeutic effectiveness was 92% in rhinosinusitis patients treated with co-amoxiclav and 84% in those treated with co-amoxiclav plus INS. Among patients with sinusitis combined with AR, therapeutic efficacy was 88% for those treated with co-amoxiclav and 96% for those treated with co-amoxiclav plus INS. Only 30% of the symptoms were reduced in the placebo group.. There are no statistical differences in the acute sinusitis group treated with co-amoxiclav with or without INS. In the sinusitis with AR group, the efficacy of co-amoxiclav with INS is higher than in children treated with co-amoxiclav alone.

Topics: Acute Disease; Administration, Intranasal; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Allergic Agents; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Fluticasone; Humans; Male; Rhinitis; Rhinitis, Allergic; Single-Blind Method; Sinusitis; Treatment Outcome

The objective of the present study was to determine whether changes in the previously developed 7-item Acute Otitis Media Severity of Symptoms scale could improve its responsiveness and its longitudinal construct validity. The items "diminished activity" and "diminished appetite" had low or borderline levels of responsiveness and longitudinal construct validity. Dropping these items seems to be potentially advantageous.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Humans; Infant; Otitis Media; Severity of Illness Index

Topics: Acute Disease; Administration, Oral; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Combined Modality Therapy; Cost Savings; Diverticulitis, Colonic; Emergency Service, Hospital; Female; Hospitalization; Humans; Infusions, Intravenous; Male; Middle Aged; National Health Programs; Self Care; Switzerland

Fluticasone propionate and nasal saline irrigation have been used in the treatment of sinonasal diseases for a long time. Our study investigates the effect of the combination of large volume low pressure nasal saline irrigation and fluticasone propionate for the treatment of pediatric acute rhinosinusitis.. Ninety-one pediatric patients with acute rhinosinusitis were included in our study. The patients were randomized into two groups. The first group (n=45) was treated with standard therapy (antibiotherapy+nasal decongestant) for 2 weeks, the second group was treated with the large volume low pressure nasal saline+fluticasone propionate combination for 3 weeks. The clinical scores, radiologic evaluations (X-ray Waters view), peak nasal inspiratory flow (PNIF) measurements, total symptom scores and hematologic parameters (WBC, CRP, ESR) of the patients were evaluated and compared.. There were no significant differences in between the two groups regarding age, gender, height and weight. Even though the clinical scores of Group 2 improved more rapidly, there were no significant differences in between groups regarding clinical scores by the 21st day. There were no significant differences in post treatment radiologic evaluations (Waters graphy). Both groups had significant improvement of their post treatment PNIF values, yet the improvement was more marked in Group 2 than in Group 1. The rhinorrhea, nasal congestion, throat itching and cough symptoms improved more rapidly in Group 2 than in Group 1. Post-treatment nose itching and sneezing symptoms were significantly less in Group 2. The values of hematologic parameters were significantly reduced at the end of the 3rd week in both groups.. Our study is a first in investigating the combined use of large volume low pressure nasal saline and fluticasone propionate in acute pediatric rhinosinusitis, and the results reveal that the combination therapy was effective. Low pressure large volume nasal saline+fluticasone propionate combination can be employed as a new line of therapy for the treatment of pediatric acute rhinosinusitis, either by itself or combined with standard therapy.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Androstadienes; Anti-Inflammatory Agents; beta-Lactamase Inhibitors; Blood Sedimentation; C-Reactive Protein; Child; Combined Modality Therapy; Female; Fluticasone; Humans; Imidazoles; Inhalation; Male; Maxillary Sinus; Nasal Decongestants; Nasal Lavage; Prospective Studies; Radiography; Rhinitis; Sinusitis; Sodium Chloride

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Finland; Humans; Infant; Otitis Media; Pennsylvania; Treatment Failure; Treatment Outcome

To evaluate the efficacy of oral anti-inflammatory or antibiotic treatment compared with placebo in the resolution of cough in patients with uncomplicated acute bronchitis and discoloured sputum.. Multicentre, parallel, single blinded placebo controlled, randomised clinical trial.. Nine primary care centres in Spain.. Adults aged 18 to 70 presenting symptoms associated with respiratory tract infection of less than one week's duration, with cough as the predominant symptom, the presence of discoloured sputum, and at least one other symptom of lower respiratory tract infection (dyspnoea, wheezing, chest discomfort, or chest pain).. Patients were randomised to receive either ibuprofen 600 mg three times daily, amoxicillin-clavulanic acid 500 mg/125 mg three times daily, or placebo three times daily for 10 days. The duration of symptoms was measured with a diary card.. Number of days with frequent cough after the randomisation visit.. 416 participants were randomised (136 to ibuprofen, 137 to antibiotic, and 143 to placebo) and 390 returned their symptom diaries fully completed. The median number of days with frequent cough was slightly lower among patients assigned to ibuprofen (9 days, 95% confidence interval 8 to 10 days) compared with those receiving amoxicillin-clavulanic acid (11 days, 10 to 12 days) or placebo (11 days, 8 to 14 days), albeit without statistically significant differences. Neither amoxicillin-clavulanic acid nor ibuprofen increased the probability of cough resolution (hazard ratio 1.03, 95% confidence interval 0.78 to 1.35 and 1.23, 0.93 to 1.61, respectively) compared with placebo. Adverse events were observed in 27 patients, and were more common in the antibiotic arm (12%) than ibuprofen or placebo arms (5% and 3%, respectively; P<0.01).. No significant differences were observed in the number of days with cough between patients with uncomplicated acute bronchitis and discoloured sputum treated with ibuprofen, amoxicillin-clavulanic acid, or placebo.. Current Controlled Trials ISRCTN07852892.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents; Bronchitis; Cough; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Ibuprofen; Male; Middle Aged; Prospective Studies; Single-Blind Method; Spain; Sputum; Treatment Outcome

10 days of amoxicillin/clavulanic acid high dose and 5 days of cefdinir have been the preferred first- or second-line antibiotics for treatment of children with acute otitis media (AOM) since 2004, as recommended by the American Academy of Pediatrics in the USA, but no head-to-head comparison study has been done.. The purpose of the study was to compare the clinical efficacy of amoxicillin/clavulanic acid high-dose therapy for 10 days with cefdinir therapy for 5 days for AOM at recommended doses.. This was an investigator-blind trial in young children 6-24 months old with no history of recurrent AOM who were randomly assigned to amoxicillin/clavulanic acid (80 mg/kg/day amoxicillin) or cefdinir (14 mg/kg/day), both in two divided doses. The diagnosis of AOM was based on specific clinical criteria by validated otoscopists at two AOM research centres. The outcome measure for clinical cure was resolution of all symptoms and signs of AOM except for persistence of middle-ear effusion at test-of-cure (TOC) 11-14 days after initiation of antibiotic treatment. Clinical failure was defined as persistence of symptoms and signs of AOM and the need for additional antibiotic therapy. Subjects lost to follow up or who had not taken at least 80% of the prescribed medication were classified as having an indeterminate response. Compliance was monitored using Medical Electronic Monitoring System (MEMS) caps and antibiotic bottle volume measurement at the TOC visit. A logistic regression model was used to estimate the association of age with cure rate. Full interactions in terms of age with treatment were included to estimate any age gradient differential.. A total of 330 children (average age 13.1 months) with AOM were studied. At TOC, 256 children had clinical cure, 69 had clinical failure, and 5 were lost to follow-up. High-dose amoxicillin/clavulanic acid-treated children had a better cure rate (86.5%) than cefdinir-treated patients (71.0%; p = 0.001). Cefdinir was correlated with less frequent cure outcomes as children increased in age between 6 and 24 months. The odds ratios for clinical cure per increasing month of age estimated from a logistic regression model for amoxicillin/clavulanic acid high dose and cefdinir treatment groups was 0.992 (95% CI 0.932, 1.056), p > 0.05 and 0.932 (95% CI 0.881, 0.986), p = 0.01. The differences in the odds ratios are significant at p < 0.002, indicating a stable clinical cure rate across the ages of children studied for amoxicillin/clavulanic acid and decreasing clinical cure rates as children increased in age for cefdinir.. In children with bona fide AOM for whom clinical outcomes are assessed by validated otoscopists, 10 days of high-dose amoxicillin/clavulanic acid is significantly more effective than 5 days of cefdinir as therapy for AOM. Because of the identified age effect (correlated to child weight), higher doses of cefdinir may have led to a different conclusion; 10 days of cefdinir may also have led to a different conclusion.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Drug Administration Schedule; Follow-Up Studies; Humans; Infant; Otitis Media; Prospective Studies; Single-Blind Method; Treatment Outcome

Acute sinusitis is a common upper respiratory tract infection worldwide, which can be severely complicated if inappropriate treatment is applied. The aim of this study was to assess and compare efficacy of cefuroxime and co-amoxiclav in the treatment of acute sinusitis in an Iranian sample population.. A randomized clinical trial, comparing the efficacy of two oral antibiotics, cefuroxime and co-amoxiclav in the treatment of acute sinusitis, was conducted in 2007. A total of 99 patients were enrolled in the study. The clinical diagnosis of acute sinusitis was based on association of suborbital pain, purulent rhinorrhea and purulent discharge on the middle nasal meatus. All patients were also radiographically examined and their diagnoses were confirmed. Patients were randomly assigned to either receive 10 days of treatment with cefuroxime 250 mg twice daily (n=57) or receive co-amoxiclav 500/125 mg three times daily (n=42). Patients responses to treatment were assessed during and at the end of the treatment.. A satisfactory clinical outcome (cure or improvement of symptoms) was found in 86% (49/57) and 71.4% (30/42) of the clinically evaluable patients treated with cefuroxime or co-amoxiclav, respectively (p >0.05).. The findings of this study suggest that cefuroxime (twice daily) is comparably effective as co-amoxiclav (three times a day) in the treatment of patients with acute sinusitis.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefuroxime; Child; Female; Humans; Iran; Male; Middle Aged; Single-Blind Method; Sinusitis; Young Adult

Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media.. We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure.. Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae.. Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Diarrhea; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Otoscopy; Prognosis; Recurrence; Regression Analysis; Streptococcus pneumoniae; Treatment Failure

The efficacy of antimicrobial treatment in children with acute otitis media remains controversial.. In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.. Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).. Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.).

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Diarrhea; Double-Blind Method; Eczema; Female; Humans; Infant; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Otitis Media; Treatment Outcome

A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection.. Children aged 3 to 48 months were enrolled and stratified into two age groups (≤ 24 months and >24 months). Pretreatment tympanocentesis was performed at all sites and was repeated during treatment at selected sites.. The primary endpoint, clinical response at the test-of-cure visit in the bacteriologic eligible population, was achieved in 80.5% of children in the azithromycin ER group and 84.5% of children in the amoxicillin/clavulanate group (difference-3.9%; 95% confidence interval-10.4, 2.6). Bacteriologic eradication was 82.6% in the azithromycin ER group and 92% in the amoxicillin/clavulanate group (p=0.050). Children who received amoxicillin/clavulanate had significantly higher rates of dermatitis and diarrhea, a greater burden of adverse events, and a lower rate of compliance to study drug compared to those who received azithromycin ER.. A single 60-mg/kg dose of azithromycin ER provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in the treatment of children with acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Humans; Infant; Otitis Media; Treatment Outcome

Evidence supporting outpatient treatment with oral antibiotics in patients with uncomplicated diverticulitis is limited. Our aim was to evaluate the safety and efficacy of an ambulatory treatment protocol in patients with uncomplicated acute diverticulitis.. All patients diagnosed with uncomplicated diverticulitis based on abdominal computed tomography findings from June 2003 to December 2008 were considered for outpatient treatment. Admission was indicated in patients not able to tolerate oral intake and those with comorbidity or without adequate family support. Treatment consisted of oral antibiotics for 7 days (amoxicillin-clavulanic or ciprofloxacin plus metronidazole in patients with penicillin allergy). Patients were seen again at between 4 and 7 days after starting treatment to confirm symptom improvement.. Ninety-six patients were diagnosed with uncomplicated acute diverticulitis and 26 presented at least one criterion for admission. Ambulatory treatment was initiated in 70 (73%) patients. Only two (3%) required admission because of persisting abdominal pain and vomiting, respectively. Intravenous antibiotics resolved the inflammatory process in both cases. In the remaining 68 (97%), ambulatory treatment was completed without complication.. Ambulatory treatment of uncomplicated acute diverticulitis is safe, effective and applicable to most patients with tolerance to oral intake and without severe comorbidity and having appropriate family support.

Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Ciprofloxacin; Diverticulitis; Drug Therapy, Combination; Female; Humans; Male; Metronidazole; Middle Aged; Prospective Studies; Treatment Outcome

The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS.. This was a randomized, double-blind, placebo-controlled study. Children 1 to 10 years of age with a clinical presentation compatible with ABS were eligible for participation. Patients were stratified according to age (<6 or >or=6 years) and clinical severity and randomly assigned to receive either amoxicillin (90 mg/kg) with potassium clavulanate (6.4 mg/kg) or placebo. A symptom survey was performed on days 0, 1, 2, 3, 5, 7, 10, 20, and 30. Patients were examined on day 14. Children's conditions were rated as cured, improved, or failed according to scoring rules.. Two thousand one hundred thirty-five children with respiratory complaints were screened for enrollment; 139 (6.5%) had ABS. Fifty-eight patients were enrolled, and 56 were randomly assigned. The mean age was 66 +/- 30 months. Fifty (89%) patients presented with persistent symptoms, and 6 (11%) presented with nonpersistent symptoms. In 24 (43%) children, the illness was classified as mild, whereas in the remaining 32 (57%) children it was severe. Of the 28 children who received the antibiotic, 14 (50%) were cured, 4 (14%) were improved, 4 (14%) experienced treatment failure, and 6 (21%) withdrew. Of the 28 children who received placebo, 4 (14%) were cured, 5 (18%) improved, and 19 (68%) experienced treatment failure. Children receiving the antibiotic were more likely to be cured (50% vs 14%) and less likely to have treatment failure (14% vs 68%) than children receiving the placebo.. ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Sinusitis; Treatment Outcome

The American Academy of Pediatrics recommendation for febrile infants and young children suspected of having a urinary tract infection is early antibiotic treatment, given parenterally if necessary. In support of this recommendation, data suggesting that delay in treatment of acute pyelonephritis increases the risk of kidney damage are cited. Because the risk was not well defined, we investigated renal scarring associated with delayed versus early treatment of acute pyelonephritis in children.. The research findings are derived from 2 multicenter, prospective, randomized, controlled studies, Italian Renal Infection Study 1 and 2, whose primary outcomes dealt with initial antibiotic treatment and subsequent prophylaxis, respectively. From the 2 studies, we selected the 287 children with confirmed pyelonephritis on acute technetium-99m-dimercaptosuccinic acid scans who underwent repeat scanning to detect scarring 12 months later. The children were 1 month to <7 years of age when they presented with their first recognized episode of acute pyelonephritis in northeast Italy.. Progressive delay in antibiotic treatment of acute pyelonephritis from <1 to >/=5 days after the onset of fever was not associated with any significant increase in the risk of scarring on technetium-99m-dimercaptosuccinic acid scans obtained 1 year later. The risk of scarring remained relatively constant at 30.7 +/- 7%. Clinical and laboratory indices of inflammation were comparable in all groups, as was the incidence of vesicoureteric reflux.. Early treatment of acute pyelonephritis in infants and young children had no significant effect on the incidence of subsequent renal scarring. Furthermore, there was no significant difference in the rate of scarring after acute pyelonephritis when infants and young children were compared with older children.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Child; Child, Preschool; Cicatrix; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Injections, Intravenous; Italy; Kidney; Male; Prevalence; Prognosis; Pyelocystitis; Radionuclide Imaging; Retrospective Studies; Time Factors; Treatment Failure

To examine study entry microbiology in patients stratified by disease severity in a clinical trial in acute bacterial exacerbation of chronic bronchitis (ABECB).. Patients were assigned to differing antibiotic therapies based on stratification by disease severity using parameters including forced expiratory volume in 1 second (FEV(1)) as a percentage of predicted value, number of exacerbations during the previous 12 months, and defined co-morbidities. All patients were required to have sputum Gram stain and culture at study entry.. There was no statistically significant difference in overall microbiology between patients with less severe and more severe clinical presentations. Typical ABECB pathogens (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) were found in 46.2% (147/318) of patients with less severe presentations and 41.9% (143/341) of patients with more severe presentations. Gram-negative organisms and Staphylococcus aureus were also found in both groups. Pneumococcal susceptibilities to the three antibiotics utilized in the trial revealed marked resistance to azithromycin. Limitations of this analysis include that the clinical trial was designed to examine clinical outcomes rather than microbiology, and that we do not correlate study entry microbiology with clinical outcomes.. Stratification of patients by disease severity did not reveal a statistically significant difference in overall microbiological profile. Gram-negative organisms and S. aureus were recovered even from patients with less severe clinical presentations. Pneumococcal resistance varied with the agent tested. These findings may have implications for the selection of appropriate antibiotic therapy.

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Bronchitis, Chronic; Double-Blind Method; Drug Resistance, Bacterial; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Ofloxacin; Severity of Illness Index; Sputum

Multiple characteristics of pretherapy Escherichia coli urine isolates from 39 children with acute, uncomplicated cystitis (including specific virulence genes and phylogenetic groups) identified an increased risk for recurrent bacteriuria after 3-day (but not 10-day) therapy with amoxicillin-clavulanate. Rapid testing conceivably could facilitate rational selection of treatment duration for pediatric cystitis. Certain traits might represent good targets for preventive interventions.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteriuria; Child; Child, Preschool; Cystitis; Escherichia coli; Escherichia coli Infections; Escherichia coli Proteins; Humans; Infant; Phylogeny; Polymerase Chain Reaction; Predictive Value of Tests; Recurrence; Virulence Factors

Acute otitis media (AOM) is one of the most common acute bacterial infection in childhood and also the most frequent reason for outpatient antibiotic therapy. Little recent information about susceptibility patterns of AOM bacterial pathogens in Turkish children has been reported.. To determine the bacterial etiology of acute otitis media in children and to compare the efficiency of 3 days course of azithromycin with a 10 days course of amoxicillin-clavulanate.. This prospective, single blind, randomised comparative study was carried out in 180 children with AOM. Paracentesis was performed for middle ear fluid culture before the first dose antibiotic therapy. Children with acute otitis media were randomised to receive either low dose amoxicillin-clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or low dose azithromycin (10mg/kg/day for 3 days). Clinical response was assessed on days 2-4, 11-13, 26-28.. Bacterial pathogens were isolated from 108 (60%) of 180 children. Streptococcus pneumoniae was the most common isolated pathogen (39.7%), followed by Haemophilus influenzae (20.7%), Moraxella catarrhalis (15.5%), Staphylococcus aureus (13.8%), Group A beta-hemolytic streptococcus (5.1%), Escherichia coli (3.4%) and Enterococcus faecalis (1.7%). This study demonstrated low resistance rates compared to studies of different countries. Although clinical response rates were better in patients treated with amoxicillin-clavulanate, this was not statistically significant [86.6% (78 of 90)] versus [95.2% (80 of 84)]. Success rates of amoxicillin-clavulanate were high for both S. pneumoniae and H. influenzae. Difference between success rates was not statistically significant (P=0.144 and 0.352).. Bacteria were isolated in 60% of AOM cases. The clinical efficiency of amoxicillin-clavulanate was found to be equal compared to azithromycin in children with acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Single-Blind Method; Treatment Outcome

The aim was to demonstrate the equivalence of the clinical efficacy and safety of cefpodoxime-proxetil (200 mg bid for 5 days) to that of amoxicillin-clavulanic acid (1 g/125 mg bid for 8 days) in adults with acute maxillary sinusitis.. In this prospective, multicenter, centrally-randomized, open-label study, 73 general practitioners and 11 ear, nose, and throat specialists included 512 patients with unilateral acute maxillary sinusitis.. The clinical success rates at day 12-19 in the per-protocol population (primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95% confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up (day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the intent-to-treat population. Compliance was significantly better in the cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported a treatment-related adverse event, compared with 10.7% (26/244) in the amoxicillin-clavulanic acid group (p<0.001). Most events were gastrointestinal and of mild to moderate intensity.. In this study, a 5-day course of cefpodoxime-proxetil at 200 mg bid was as clinically effective as amoxicillin-clavulanic acid 1 g/125 mg bid for 8 days with a significantly better safety profile and compliance.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Confidence Intervals; Enzyme Inhibitors; Female; Follow-Up Studies; Humans; Male; Maxillary Sinusitis; Patient Compliance; Patient Selection; Prospective Studies; Time Factors; Treatment Outcome

The main aim of treatment for acute necrotizing periodontal disease is fast and effective reduction of anaerobic destructive microorganisms to avoid periodontal damage. The effect of adjunctive local oxygen therapy in the treatment of necrotizing periodontal disease was examined in this study.. Thirty patients with acute necrotizing periodontal disease were treated with the systemic antibiotics amoxicillin, clavulanic acid, and metronidazole. In 15 out of 30 patients, adjunctive local oxygen therapy was administered. The patients were followed from the first to 10th day of treatment with clinical and bacteriological examinations. The clinical examination registered gingival bleeding, periodontal probing depth, and attachment loss; to follow up microbiological colonization of the periodontal sulcus, five representative bacteria were registered by a semiquantitative DNA polymerase chain reaction test.. In both groups of patients, colonization with Prevotella intermedia, Tannerella forsythensis, and Treponema denticola was initially positive. None of these three microorganisms were completely eradicated in any of the patients in the group without oxygen therapy within the first 10 days of treatment. In the group with adjunctive oxygen therapy, all patients either showed a reduction in or complete eradication of the microorganisms, resulting in more rapid clinical restitution with less periodontal destruction.. Adjunctive oxygen therapy results in early eradication of pathogenic anaerobic microorganisms in cases of acute necrotizing periodontal disease. The damage to periodontal tissue is reduced.

Topics: Acute Disease; Administration, Topical; Adult; Aggregatibacter actinomycetemcomitans; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Bacteroides; Follow-Up Studies; Gingival Hemorrhage; Humans; Metronidazole; Middle Aged; Necrosis; Oxygen; Periodontal Attachment Loss; Periodontal Pocket; Periodontitis; Porphyromonas gingivalis; Prevotella intermedia; Smoking; Treponema denticola

To compare efficacy, tolerability, and parental satisfaction of cefdinir and high-dose amoxicillin/clavulanate oral suspensions given to young children with non-refractory acute otitis media (AOM) based on clinical endpoints and outcomes measures.. This was an investigator-blinded, multicenter study in which 318 children 6 months through 6 years of age with a clinical diagnosis of AOM were randomized to receive 10 days of either cefdinir (14 mg/kg divided BID) or high-dose amoxicillin/clavulanate (90/6.4 mg/kg divided BID).. Investigators evaluated clinical response at an end-of-therapy (EOT) office visit conducted on day 12-15. Outcomes of satisfaction, tolerability, and adherence were also assessed at that visit using an Otitis Parent Questionnaire.. The treatment groups were similar at baseline with respect to patient demographics. At the EOT visit, for cefdinir and amoxicillin/clavulanate, respectively, intent-to-treat (ITT) clinical cure rates were 82% (129/158) and 85% (134/158) (p = 0.547; 95% confidence interval [CI] -11.7 to 5.4) and per-protocol cure rates were 82% (123/150) and 90% (129/143) (p = 0.045; 95% CI -16.4 to 0.0). This difference was driven primarily by reduced cefdinir response in patients with recurrent AOM (p = 0.010) and those younger than 24 months (p = 0.039). Comparing cefdinir with amoxicillin/clavulanate, parents more often reported significantly better ease of use (89% vs. 57%; p < 0.0001), better taste (85% vs. 39%; p < 0.0001), and better adherence (at least 95% of doses) (82% vs. 61%; p < 0.0001). Diarrhea/loose stools were more common in the amoxicillin/clavulanate group than in the cefdinir group (28% vs. 18%, respectively; p = 0.0341). One patient in the cefdinir group and eight patients in the amoxicillin/clavulanate group withdrew from the study prematurely due to at least one adverse event (p = 0.0364). Study limitations included assessment of clinical recurrence by telephone call rather than office visit, exclusion of children with refractory AOM, and no assessment of middle ear microbiology.. Among young children with non-refractory AOM, cefdinir was as efficacious as high-dose amoxicillin/clavulanate in the ITT group, but somewhat less effective in per-protocol analysis. From the parental perspective, cefdinir was easier to administer, had a better taste, caused less diarrhea, and resulted in higher treatment adherence than high-dose amoxicillin clavulanate.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Humans; Infant; Male; Otitis Media; Parents; Prospective Studies; Treatment Outcome

This randomized, controlled trial was designed to show that a short, 5-day course of pharmacokinetically enhanced amoxicillin-clavulanate at 2,000/125 mg (Augmentin XR) is as effective clinically as a longer, 7-day course of conventional amoxicillin-clavulanate at 875/125 mg (both given twice daily) in the treatment of acute exacerbations of chronic bronchitis (AECB). Amoxicillin-clavulanate at 2,000/125 mg was designed to extend the therapeutic levels of amoxicillin in serum over the 12-h dosing interval, compared with conventional formulations, to eradicate bacterial strains for which amoxicillin MICs were < or =4 microg/ml while retaining efficacy against beta-lactamase-producing pathogens. A total of 893 patients were randomized and received study medication (amoxicillin-clavulanate at 2,000/125 mg for 443 patients and 875/125 mg for 450 patients). Overall, 141 patients receiving amoxicillin-clavulanate at 2,000/125 mg and 135 receiving the comparator formulation had at least one pathogen identified at screening. Amoxicillin-clavulanate at 2,000/125 mg was as effective clinically in the per-protocol (PP) population at the test of cure (days 14 to 21, primary efficacy endpoint) as amoxicillin-clavulanate at 875/125 mg (clinical success rates of 93.0 and 91.2%, respectively; treatment difference, 1.8; 95% confidence interval [CI], -2.2, 5.7). Bacteriological success in the bacteriology PP population was high for both formulations (amoxicillin-clavulanate at 2,000/125 mg, 76.7%; amoxicillin-clavulanate at 875/125 mg, 73.0%; treatment difference, 3.8; 95% CI, -7.5, 15.0). Both therapies were well tolerated, with a similar incidence of adverse events. Fewer than 5% of patients in each group withdrew from the study due to adverse events. The shorter, 5-day course of amoxicillin-clavulanate at 2,000/125 mg was shown to be as effective clinically as a longer, 7-day course of amoxicillin-clavulanate at 875/125 mg, with high bacteriological efficacy and no difference in tolerability.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis, Chronic; Double-Blind Method; Female; Haemophilus influenzae; Haemophilus parainfluenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Streptococcus pneumoniae; Treatment Outcome

Acute Otitis Media (AOM) is the most frequent respiratory tract infection of infancy and childhood that is treated with antimicrobial agents. The most common causative pathogens include Streptococcus pneumoniae, Hemophilus influenzae and Moxarella catarrhalis, and therefore antibacterial management should target against these isolates. Cefaclor, a congener of cephalexin monohydrate, is a semisynthetic cephalosporin antibiotic. It is an orally active cephalosporin which has demonstrated activity against a wide range of organisms in vitro. Present study is designed as a multicentric prospective trial to study and compare the efficacy and safety of cefaclor versus amoxicillin + clav in children with acute otitis media. One hundred and sixty seven patients were evaluated for efficacy endpoints in the cefaclor arm comprised of 104 males and 63 females with a mean age of 5.74+/-2.80 years and 185 patients in the amoxy-clav group comprised of 118 males and 67 females with a mean age of 4.93+/-2.92 years. Both cefaclor and amoxy-clav caused a significant improvement in all the signs and symptoms after a 10-day treatment period. However, between-the-group comparisons showed that the reduction in most of the symptoms was significantly more in cefaclor arm as compared to amoxicillin-clav arm. The clinical success (clinical cure + improvement) at the end of therapy was significantly more in cefaclor arm: 98% with cefaclor versus 85% with amoxicillin + clav, p<0.05 Table 3. Failure cases were prescribed other antibiotics according to the culture sensitivity reports, as rescue medication. Bacterial eradication rates were largely consistent with clinical responses. Bacteriological eradication was seen in 95% of patients in cefaclor group and 78% of patients in amoxicillin + clav group. In conclusion, cefaclor is a well tolerated and effective antibacterial option for acute otitis media in children and it is superior to the combination of amoxicillin + clav in efficacy and tolerability in acute AOM. Moreover, its expanded spectrum of activity, ability to achieve adequate concentrations in tissues, suitability for twice-daily dosing, and proven tolerability suggest that it is a good alternative to agents traditionally used in acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefaclor; Child; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media; Prospective Studies; Streptococcus pneumoniae; Treatment Outcome

Recurrent otitis media and acute otitis media treatment failure are commonly encountered in the pediatric population.. To compare the clinical efficacy of gatifloxacin with amoxicillin/clavulanate for the treatment of acute otitis media treatment failure and recurrent otitis media.. Three hundred fifty-four children 6 months-7 years with recurrent otitis media and/or acute otitis media failure were stratified according to age (younger than 2 years versus 2 years or older) and then randomly assigned to 10 days of treatment with gatifloxacin 10 mg/kg once daily or amoxicillin/clavulanate 90 mg/6.4 mg in 2 divided doses. Tympanocentesis was performed in 116 children with acute otitis media treatment failure and 52 with recurrent otitis media at study entry to validate the clinical diagnosis and provide microbiologic data. The primary outcome measure was clinical resolution of infection at the test-of-cure visit 3-10 days after completing treatment.. Clinical resolution of acute otitis media was observed in 79.0% (49 of 62) of clinically evaluable children younger than 2 years and 90.3% (56 of 62) of those 2 years or older who were treated with gatifloxacin as compared with 77.6% (45 of 58) of children younger than 2 years and 79.7% (47 of 59) of children 2 years or older treated with amoxicillin/clavulanate. In patients with acute otitis media treatment failure, clinical response rates for children younger than 2 years and those 2 years or older were 87.5% (21 of 24) and 97.0% (32 of 33) with gatifloxacin versus 63.6% (14 of 22) and 83.9% (26 of 31) with amoxicillin/clavulanate. The corresponding clinical response rates in patients with recurrent otitis media were 79.2% (19 of 24) and 85.7% (18 of 21) with gatifloxacin and 90.5% (19 of 21) and 76.0% (19 of 25) with amoxicillin/clavulanate. Clinical success in those subjects having pretreatment middle ear fluid pathogens was similar for the 2 regimens [80.0% (24 of 30) gatifloxacin, 77.1% (27 of 35) amoxicillin/clavulanate]. Emergence of fluoroquinolone-resistant strains was not observed. Both drugs were generally well-tolerated. Diarrhea was the most common drug-related adverse event (10% gatifloxacin, 18% amoxicillin/clavulanate). No evidence of abnormal joint or gait findings was found during a 12-month follow-up.. Gatifloxacin once daily is at least as effective and well-tolerated as amoxicillin/clavulanate twice daily in children with acute otitis media treatment failure or recurrent otitis media. There was no evidence of arthrotoxicity or emergence of fluoroquinolone-resistant bacteria in gatifloxacin-treated children.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child; Child, Preschool; Female; Fluoroquinolones; Gatifloxacin; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Recurrence; Single-Blind Method; Streptococcus pneumoniae; Treatment Failure; Treatment Outcome

To compare the efficacy and tolerability of clarithromycin extended-release (ER) to amoxicillin/ clavulanate in patients diagnosed with acute bacterial sinusitis.. In a controlled, multicenter, investigator-blinded study, 437 ambulatory patients at least 12 years old with signs/symptoms and radiographic findings of acute sinusitis were randomized to receive clarithromycin ER 1000 mg once daily or amoxicillin/ clavulanate 875 mg/l25 mg twice daily for 14 days.. Clinical and bacteriological response rates were determined at a test-of-cure visit, which was conducted up to 10 days following the completion of treatment. Radiological response was assessed at a follow-up visit.. The clinical cure rate in clinically evaluable patients was 98% (184/188) in the clarithromycin ER group and 97% (179/185) in the amoxicillin/clavulanate group (95% CI for the difference in rates [-2.4%, 4.7%]). Clinical cure was sustained at the follow-up visit (96% for each treatment group). The pathogen eradication rates were 94% (61/65) in the clarithromycin ER group and 98% (61/62) in the amoxicillin/clavulanate group (95% CI for difference in rates [-12.0%, 2.9%]). The radiological success rate was 94% (172/183) in both the clarithromycin ER and amoxicillin/clavulanate groups (95% CI for difference in rates [-4.9%, 4.9%]). Symptomatic improvement or relief was observed as early as 2 days-5 days after the initiation of study drug, with a statistically significantly higher resolution rate of sinus pressure (p = 0.027) and improvement/resolution rate of nasal congestion (p = 0.035) during treatment with clarithromycin ER. The resolution/improvement rate at the test-of-cure visit for each treatment group was > or = 94% for the primary acute sinusitis signs/symptoms, with a statistically significantly higher resolution/improvement rate of purulent nasal discharge with clarithromycin ER (p = 0.010). Both study drugs had a positive and rapid impact on quality of life. Patients reported a high level of satisfaction and probability of using either study antibiotic again, and health care resource use was low, with slightly fewer sinusitis-related physician and outpatient visits required by patients in the clarithromycin ER group (p = 0.055). The treatment groups were comparable with respect to incidence of drug-related adverse events.. In this multinational population of patients with acute bacterial sinusitis, clarithromycin ER was comparable, and for selected measures superior, to amoxicillin/clavulanate based on clinical, bacteriological, and radiological responses as well as quality of life measures, satisfaction with antibiotic therapy, and health care resource utilization.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Anti-Bacterial Agents; Clarithromycin; Delayed-Action Preparations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Single-Blind Method; Sinusitis; Treatment Outcome

The effect on the nasopharyngeal bacterial flora of 10 days of amoxycillin-clavulanate or cefdinir antimicrobial therapy was studied in 50 children with acute otitis media. Before therapy, 17 potential pathogens (Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) were isolated from the nasopharynx of 14 (56%) of those treated with amoxycillin-clavulanate, and 20 potential pathogens were recovered from 15 (60%) of those treated with cefdinir. Following therapy, at days 12-15, the number of potential pathogens was reduced to a similar extent with both therapies, to three in those treated with amoxycillin-clavulanate and two in those treated with cefdinir. However, the number of potential pathogens rebounded faster in those treated with amoxycillin-clavulanate as compared with cefdinir in the two subsequent specimens taken at days 30-35 and 60-65 (12 and 18 in the amoxycillin-clavulanate group, and six and nine in the cefdinir group, P < 0.01 and P < 0.001, respectively). Differences between the groups were also noted in the recovery of organisms with interfering capability. Immediately following amoxycillin-clavulanate therapy, the number of interfering organisms declined from 54 to 13, while following cefdinir treatment their number was reduced from 59 to 39 (P < 0.001). The differences between the two therapy groups persisted in the two later specimens taken at days 30-35 and 60-65 (25 and 38 in the amoxycillin-clavulanate group, and 52 and 51 in the cefdinir group, P < 0.001 and P < 0.05, respectively). This study illustrates the potential beneficial effect of using a narrow-spectrum antimicrobial that selectively spares the interfering organisms while eliminating pathogens. The benefit of such therapy is the prevention of reacquisition of pathogenic bacteria in the nasopharynx. In contrast, utilization of a broad-spectrum antimicrobial is associated with prolonged absence of inhibitory organisms and rapid recolonization with pathogens.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Cephalosporins; Child; Colony Count, Microbial; Haemophilus influenzae; Humans; Moraxella catarrhalis; Nasopharynx; Otitis Media; Streptococcus pneumoniae; Time Factors

A large dosage pediatric formulation of amoxicillin/clavulanate with an improved pharmacokinetic/pharmacodynamic profile was developed to eradicate many penicillin-resistant strains of Streptococcus pneumoniae and Haemophilus influenzae (including beta-lactamase-producing strains).. This randomized, investigator-blinded, multicenter trial examined treatment of bacterial acute otitis media (AOM) in children 6-30 months of age with amoxicillin/clavulanate (90/6.4 mg/kg/d in 2 divided doses for 10 days) versus azithromycin (10 mg/kg for 1 day followed by 5 mg/kg/d for 4 days). Tympanocentesis was performed at entry for bacteriologic assessment, at the on-therapy visit (day 4-6) to determine bacterial eradication and at any time before the end-of-therapy visit (day 12-14) if the child was categorized as experiencing clinical failure. Clinical assessments were performed at the on-therapy, end-of-therapy and follow-up (day 21-25) visits.. We enrolled 730 children; AOM pathogens were isolated at baseline for 249 of the amoxicillin/clavulanate group and 245 of the azithromycin group. For children with AOM pathogens at baseline, clinical success rates at the end-of-therapy visit were 90.5% for amoxicillin/clavulanate versus 80.9% for azithromycin (P < 0.01), and those at the on-therapy and follow-up visits were 94.9% versus 88.0% and 80.3% versus 71.1%, respectively (all P < 0.05). At the on-therapy visit, pretherapy pathogens were eradicated for 94.2% of children receiving amoxicillin/clavulanate versus 70.3% of those receiving azithromycin (P < 0.001). Amoxicillin/clavulanate eradicated 96.0% of S. pneumoniae (92.0% of fully penicillin-resistant S. pneumoniae) and 89.7% of H. influenzae (85.7% [6 of 7 cases] of beta-lactamase-positive H. influenzae). Corresponding rates for azithromycin were 80.4% (54.5%) for S. pneumoniae and 49.1% (100% [1 of 1 case]) for H. influenzae (all P < 0.01 for between-drug comparisons).. Amoxicillin/clavulanate was clinically and bacteriologically more effective than azithromycin among children with bacterial AOM, including cases caused by penicillin-resistant S. pneumoniae and beta-lactamase-positive H. influenzae.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Streptococcus pneumoniae; Treatment Outcome

To identify risk factors for late recovery and failure after ambulatory treatment of exacerbations of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD).. Observational, non-randomised study of risk factors carried out in 2001 and 2002 in Primary Care practices. Patients aged 40 or older diagnosed with an exacerbation of CB or COPD of probable bacterial etiology were included in the study and followed up for 10 days. Patients were treated with amoxicillin plus clavulanic acid (co-amoxiclav) 500-125 mg tds for 10 days, clarithromycin 500 mg bd for 10 days or moxifloxacin 400 mg od for 5 days.. Two hundred and fifty-two general practitioners participated, registering 1147 valid patients. The rate of failure at day 10 was 15.1% without significant differences among the antibiotic treatments. Median time to recovery was 5 days. Factors significantly associated with late recovery (>5 days) on multivariate analysis were: use of long-term oxygen (OR=1.96; 95%CI=1.35-2.85); use of short-acting beta-2 agonists (OR=1.51; 1.17-1.92). The use of moxifloxacin had a "protective" effect against late recovery compared to co-amoxiclav (OR=0.34; 0.26-0.45) and clarithromycin (OR=0.41; 0.31-2.85). Factors associated with therapeutic failure were: previous hospitalisation (OR=1.61; 1.08-2.42); and 2 or more exacerbations the previous year (OR=1.51; 1.04-2.17); criteria of CB had a protective effect against failure (OR=0.53; 0.35-0.79).. There are readily identifiable risk factors for ambulatory treatment failure of exacerbations of CB and COPD. In addition, long-term oxygen therapy and short-acting beta-2 agonists are associated with late recovery, and the use of moxifloxacin compared with co-amoxiclav and clarithromycin is associated with faster recovery of symptoms.

Topics: Acute Disease; Adrenergic beta-Agonists; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bronchitis, Chronic; Clarithromycin; Drug Therapy, Combination; Epidemiologic Methods; Female; Fluoroquinolones; Humans; Male; Middle Aged; Moxifloxacin; Oxygen Inhalation Therapy; Prognosis; Pulmonary Disease, Chronic Obstructive; Quinolines; Treatment Outcome

Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi) are the leading bacterial cause of acute otitis media (AOM), having the nasopharynx (NP) as their reservoir. In October 2001 we began a prospective, multicenter, randomized, evaluator blind study, comparing the efficacy of amoxicillin-sulbactam (Ax/S) and amoxicillin-clavulanic acid (Ax/C) for the treatment of non-recurrent AOM (nr-AOM). Both antimicrobial susceptibility (AS) to Ax/S and Ax/C from Sp and Hi carried by study children (aged 6-48 months with nr-AOM) and, clinical outcome after treatment with high dose of either Ax/C (7:1) or Ax/S (4:1) (amoxicillin dose: 80 mg/(kg day), b.i.d. for 10 days) were assessed. Nasal cultures (NCs) were taken at Day 0. Follow-up NCs, were done only for Sp carriers. On final analysis 247/289 pts (85.5%) were fully evaluable (120 Ax/S and 127 Ax/C). NP carriage rate of Hi and Sp at Day 0 was 32.2% (93/289 pts) and 28.7% (83/289 pts), respectively. Persistent Sp carriage was detected only in 2 pts. Hi betalactamase positive rate was 13% (12/93). MICs for Ax/S and Ax/C were identical when tested against Sp and Hi isolates (range < or = 0.016-1.0 and < or = 0.016-0.25 mg/L, respectively). Clinical efficacy at Days 12-14 and 28-42 were 98.3% (115/117) and 94.2% (97/103) for Ax/S; and 98.3% (115/117) and 95.1% (98/103) for Ax/C, respectively (pNS). We conclude, that Sp and Hi isolated from NCs of nr-AOM pts were highly sensitive to both drugs and correlated with high clinical efficacy rate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Argentina; Carrier State; Child, Preschool; Drug Administration Schedule; Drug Combinations; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Prospective Studies; Single-Blind Method; Streptococcus pneumoniae; Sulbactam; Treatment Outcome

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Administration Schedule; Haemophilus Infections; Haemophilus influenzae; Humans; Maxillary Sinusitis; Radiography; Streptococcal Infections; Streptococcus pneumoniae; Streptococcus pyogenes

In order to evaluate the clinical efficacy and safety profiles of single-dose ceftriaxone (50 mg/kg, not exceeding 1 g) and a 10-day course of amoxicillin-clavulanate (amoxi-clav) [45 mg/kg/day, in 3 divided doses] in children with acute otitis media (AOM), we conducted a prospective, comparative, randomized trial. Between February 2000 and April 2002, 110 children with a mean age of 30.73 +/- 20.79 months were enrolled. 109 patients were evaluated for the safety assessment. The intent-to treat population included 96 patients who completed at least 3 days of treatment. The standard analysis population included 73 patients who completed the 10-day treatment period without any major violation. For the standard analysis population, 57 out of 73 patients experienced treatment success; 31 out of 41 patients in the ceftriaxone group were cured compared with 25 out of 32 patients in the amoxi-clav group. The rate of persistence of middle-ear fluid did not differ between the 2 groups at day 11 or day 28. A higher treatment preference rate was observed in the ceftriaxone group (93.9% vs 58.6%). The most common drug-related adverse effects were found in the digestive system, skin and appendages in both treatment groups. A single dose of ceftriaxone is as safe and effective as amoxi-clav for curing patients with acute otitis media. In addition, a substantially higher proportion of patients receiving single-dose ceftriaxone showed a preference for the study medication compared with those treated with amoxi-clav for 10 days.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Child; Child, Preschool; Female; Humans; Infant; Injections, Intramuscular; Male; Otitis Media; Prospective Studies; Treatment Outcome

The objective of the study was to compare the clinical efficacy and bacteriological response of levofloxacin and amoxicillin/clavulanic acid (co-amoxiclav) in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily (LEV group) or co-amoxiclav 625 mg three times a day (COA group) for 14 days. Thirty four patients were in the LEV group and 26 patients were in the COA group. The mean total symptom score was significantly decreased after treatment and was comparable between both groups. Radiological improvement was 61.8% in the LEV group (41.2% resolution, 20.6% improvement) and 61.5% in the COA group (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the LEV group and 20 patients (76.9%) in the COA group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa. There were no significant changes in vital sign measurements or hemato-biochemical parameters at the end of treatment as compared to baseline values, in both groups. Adverse events were found in 8.8% of patient in the LEV group and in 7.7% of patients in the COA group. Adverse events included nausea, abdominal pain, and diarrhea. All the adverse events in both groups were mild and resolved spontaneously. This study demonstrated that levofloxacin 300 mg orally once daily was as effective and safe as amoxicillin/clavulanic acid 625 mg three times a day in the treatment of maxillary sinusitis, either acute or acute exacerbation. Both drugs showed bacteriological efficacy that was not significantly different. The once daily dosage regimen is more applicable, convenience and has better compliance.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Drug Therapy, Combination; Female; Humans; Levofloxacin; Male; Maxillary Sinusitis; Middle Aged; Ofloxacin; Suppuration

Clarithromycin and amoxicillin/clavulanate (A/C) are first line antibiotics used to treat uncomplicated acute rhinosinusitis (ARS). This study examined the efficacy of clarithromycin and A/C for the treatment of ARS relative to the patient's quality of life (QOL).. Twenty-two patients with uncomplicated ARS were randomly assigned treatment (single blinded relative to the investigator) using clarithromycin or A/C. Patients underwent assessment to confirm the diagnosis and treatment outcome at the initial screening and on completion of antibiotics (diagnosis + 14 days and 28 days). QOL was evaluated using the Allergy Outcomes Survey (AOS), the Rhinoconjunctivitis QOL Questionnaire (RQLQ), the Short Form 36 survey (SF-36), an instantaneous six-item Symptom Severity Survey (SSS-6), and a Visual Analogue Scale (VAS). Surveys were completed at the time of diagnosis, on completion of antibiotics, and at 28 days after diagnosis.. Twenty patients completed the study. The SSS-6 and the RQLQ demonstrated significant improvement for all patients at week 4 (P =.002 and P =.003, respectively). The SSS-6 demonstrated significant improvement for clarithromycin at 14 days (P =.02) and at 28 days (P =.029), whereas A/C patients demonstrated significant improvement in symptoms only at 28 days (P =.046). The RQLQ, which reflects the previous 2 weeks, demonstrated significant improvement for the A/C patients at 28 days (P =.01). The Allergy Survey, the SF-36, and the VAS failed to demonstrate significant improvement in the combined data analysis.. Clarithromycin and A/C were equally effective in treating ARS. The clarithromycin patients felt better more rapidly (at 14 days), but both groups of patients had long-term improvement in symptoms at 28 days.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clarithromycin; Drug Therapy, Combination; Humans; Quality of Life; Rhinitis, Allergic, Perennial; Severity of Illness Index; Single-Blind Method; Sinusitis; Surveys and Questionnaires

Pristinamycin is a bactericidal antibiotic whose spectrum covers the main respiratory pathogens including S. pneumoniae poorly sensitive to penicillin. It has not yet been evaluated in short course treatment of acute exacerbations of chronic obstructive bronchitis (AECB).. 476 patients suffering from an AECB were randomised to either a short course of pristinamycin, 3 G daily for 4 days, or conventional treatment with co-amoxiclav (AAC) 2G daily for 8 days. The duration of follow-up was 6 months.. The clinical success rate at 21 days was the same in both groups at 87.2% and 87.9%, CI95% [-7.0%, 6.0%], in the protocol population (FEV1<80%). Among the 120 patients in whom a bacterial pathogen was isolated at the time of inclusion a satisfactory bacteriological response was obtained in 84.6% of the PRI patients against 78.2% of the AAC patients. The time to relapse was comparable with a relapse rate of 25% reached in 128 days in the PRI group and 125 days in the AAC group. Treatment related side effects occurred in 9.2% of the PRI group and in 10.6% of the AAC group.. Pristinamycin 3 G daily for 4 days is as effective and well tolerated as co-amoxiclav 2G daily for 8 days in the treatment of AECB.

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Chronic Disease; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Patient Selection; Pneumonia, Bacterial; Pristinamycin; Prospective Studies; Pulmonary Disease, Chronic Obstructive; Treatment Outcome

Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial and/or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The potential benefit of routine antibiotic therapy in the absence of evidence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit (or lack thereof) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.. This is a multicenter, randomized, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo. Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ failure. Patients recently hospitalized, having received antibiotics for > 24 h, or on long-term steroids will not be included. Co-interventions (bronchodilators, steroids) are controlled for. Patients will be administered the antibiotic or placebo within 24 hours of admission.. A 20% reduction of the duration of clinical symptoms of exacerbation is expected. To this end, 520 patients are planned to be included in 15 centers in a 2-year period. Secondary end-points are the incidence of documented infection (lower respiratory tract or other sites), antibiotic use, the proportion of patients having infection with resistant bacteria, the incidence of endotracheal intubation, the duration of stay and mortality in the ICU and the hospital.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Critical Care; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; Hospital Mortality; Humans; Incidence; Intubation, Intratracheal; Length of Stay; Morbidity; Multicenter Studies as Topic; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Time Factors; Treatment Outcome

Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States.. In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28).. With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018). For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Probability; Prospective Studies; Reference Values; Risk Assessment; Single-Blind Method; Treatment Outcome

Short course antimicrobial therapy is suggested for group A streptococcal tonsillopharyngitis.. The bacteriologic and clinical efficacies of clarithromycin [30 or 15 mg/kg/day twice daily (b.i.d.)] or amoxicillin/clavulanate (43.8/6.2 mg/kg/day b.i.d.) for 5 days or penicillin V (30 mg/kg/day 3 times a day) for 10 days were compared. In a randomized, open label, parallel group, multicenter study, 626 children (2-16 years old) with tonsillopharyngitis were enrolled; 537 were evaluable for efficacy. Follow-up evaluations were performed at 4-8 and 21-28 days after therapy.. At enrollment, 26% of the Streptococcus pyogenes isolates were clarithromycin-nonsusceptible. All regimens had an apparently similar clinical efficacy. The long term S. pyogenes eradication rates were 102 of 123 (83%) with amoxicillin/clavulanate and 88 of 114 (77%) with penicillin V. In the 30- and 15-mg/kg/day clarithromycin groups, eradication occurred in 71 of 86 (83%) and 59 of 80 (74%) of the clarithromycin-susceptible isolates (P = 0.33), and in 4 of 28 (14%) and 5 of 26 (19%) of the clarithromycin-resistant isolates, respectively (clarithromycin-susceptible versus -resistant, P < 0.0001). Both clarithromycin dosages were well-tolerated.. In group A streptococcal tonsillopharyngitis, 5 days of clarithromycin or amoxicillin/clavulanate treatment had clinical efficacy comparable with that of 10 days of penicillin V treatment; however, amoxicillin/clavulanate and penicillin V were bacteriologically more effective than clarithromycin because of its failure to eradicate the clarithromycin-resistant S. pyogenes isolates. The 5-day clarithromycin regimens are not recommended for treatment of streptococcal tonsillopharyngitis in areas where in vitro resistance of group A streptococci to clarithromycin is common.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clarithromycin; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Penicillin V; Pharyngitis; Probability; Reference Values; Risk Assessment; Severity of Illness Index; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis; Treatment Outcome

The conventional treatment of acute appendicitis is appendectomy followed by intravenous (IV) antibiotics until intraabdominal infection has resolved. It is controversial as to whether it is efficacious to add a course of oral antibiotics after cessation of IV antibiotics. All consenting patients who presented to Kern Medical Center between October 2000 and June 2003 with acute appendicitis were entered into the study. Perforated/gangrenous appendicitis was equally represented in the two study arms. After appendectomy, and when IV antibiotics were ready to be discontinued, patients were randomized to receive a 7-day outpatient course of either placebo (Group 1) or oral antibiotics (Group 2). Patients were monitored for infectious complications for a minimum of 3 months, and there was no statistical difference (11.5% in Group 1 vs 12.1% in Group 2, P = 0.61). The data suggest that adding a course of outpatient oral antibiotics, after completing a course of IV antibiotics, does not decrease postoperative infectious complications in appendicitis patients.

Topics: Abdominal Abscess; Acute Disease; Administration, Oral; Adolescent; Adult; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendectomy; Appendicitis; Child; Double-Blind Method; Female; Humans; Male; Ofloxacin; Postoperative Period; Prospective Studies; Surgical Wound Infection; Treatment Outcome

The role of routine antimicrobial treatment of acute middle-ear infections is under debate, because the efficacy of antimicrobials in the resolution of middle-ear fluid has not been unambiguously proven. Acute tube otorrhea is regarded as evidence of acute otitis media, and for methodologic reasons it was chosen to provide objectivity for diagnostics and outcome assessment. The objective of this study was to assess whether amoxicillin-clavulanate accelerates the resolution of acute tube otorrhea.. Randomized, double-blind, placebo-controlled study in outpatient setting.. Volunteer sample of basically healthy 6- to 72-month-old children with a tympanostomy tube. Eligibility required having acute tube otorrhea of <48 hours' of duration and no prior treatment within the last 2 weeks. The mean age of the participants was 25 months; they had a history of 3 episodes of acute otitis media (median), and 99% had manifestations of a concomitant respiratory infection. Of 79 randomized patients, 7 were withdrawn because of adverse events; 66 patients completed the study.. Amoxicillin-clavulanate (N = 34; 45 mg/kg/d) or matching placebo (N = 32) for 7 days and daily suction of middle-ear fluid through tympanostomy tube.. Duration of acute tube otorrhea and duration of bacterial growth in middle-ear fluid.. The median duration of tube otorrhea was significantly shorter in amoxicillin-clavulanate than in the placebo group (3 vs 8 days). At the end of the 7-day medication period, tube otorrhea was resolved in 28 of 34 children receiving amoxicillin-clavulanate compared with 13 of 32 children on placebo (treatment-control difference 41%; 95% confidence interval, 20%-63%; number needed to treat, 2.4). The median duration of bacterial growth in middle-ear fluid was shorter in amoxicillin-clavulanate than in the placebo group (1 vs 8 days).. Oral antibiotic treatment significantly accelerates the resolution of acute tube otorrhea by reducing bacterial growth in middle-ear fluid.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Gram-Negative Bacterial Infections; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Middle Ear Ventilation; Moraxella catarrhalis; Otitis Media, Suppurative; Pneumococcal Infections; Streptococcus pneumoniae

In a randomized double-blind trial 251 adults with sinusitis-like symptoms were given amoxicillin/clavulanate or placebo for 6 days. Seven diagnostic indicators for acute bacterial rhinosinusitis are compared by their accuracy assuming a latent class model and by the treatment effect that they would have had if used to select a subset of patients for antibiotic treatment. Under a latent class model, radiography is a more efficient indicator then C reactive protein (CRP), which is, in turn, more efficient than other clinical signs and symptoms. However, a history of purulent nasal discharge, and signs of pus in the nasal cavity and throat, are better criteria than radiography or CRP for selecting those patients who will benefit from antibiotic treatment. These contradictory results are a salutary reminder that diagnostic indicators need to be evaluated in terms of therapeutic consequences for the patient.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Biomarkers; C-Reactive Protein; Double-Blind Method; Drug Therapy, Combination; Family Practice; Humans; Models, Statistical; Odds Ratio; Patient Selection; Rhinitis; Sinusitis; Treatment Outcome

Compared with 5 days of dosing, a 3 day dosing regimen of azithromycin for treatment of acute otitis media (AOM) may improve compliance, will simplify therapy for the caregiver and, by giving the same total dose as the 5 day regimen, provide more drug when the bacterial burden is highest.. Children of 6 months-12 years were enrolled if they had had symptoms and signs of AOM for <4 weeks and tympanic membrane effusion by acoustic reflectometry. Eligible children were randomized to azithromycin 10 mg/kg/day x 3 days or co-amoxiclav 45 mg/kg/day x 10 days. The primary endpoint was clinical response at day 28.. One hundred and eighty-eight children (mean age 3.5 years) were randomized to azithromycin and 185 to co-amoxiclav. At day 10, the clinical success rate was 153/185 (83%) in children treated with azithromycin and 159/181 (88%) in children treated with co-amoxiclav. At day 28, 134/182 (74%) of the children were cured on azithromycin compared with 124/180 (69%) on co-amoxiclav. Also at day 28, signs of AOM, such as abnormal reflectometry (45% versus 59%; P = 0.017), bulging of the eardrum (10% versus 16%; P = 0.059) and loss of tympanic membrane landmarks (11% versus 22%; P = 0.010) were seen less frequently in azithromycin- than co-amoxiclav-treated children, respectively. Adverse events related to therapy were seen in 11% of azithromycin patients compared with 20% on co-amoxiclav (P = 0.014).. Azithromycin given over 3 days is as effective as co-amoxiclav for treatment of AOM, may result in more complete resolution of tympanic membrane disease, and is better tolerated.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Female; Hearing Tests; Humans; Infant; Male; Otitis Media; Treatment Outcome; Tympanic Membrane

A randomized, double-blind, multicenter study of adults with acute bacterial sinusitis (ABS) compared the efficacy and safety of two azithromycin (AZM) regimens, 500 mg/day once daily for 3 days (AZM-3) or 6 days (AZM-6) to the efficacy and safety of an amoxicillin-clavulanate (AMC) regimen of 500-125 mg three times daily for 10 days. A total of 936 subjects with clinically and radiologically documented ABS were treated (AZM-3, 312; AZM-6, 311; AMC, 313). Clinical success rates were equivalent among per-protocol subjects at the end of therapy (AZM-3, 88.8%; AZM-6, 89.3%; AMC, 84.9%) and at the end of the study (AZM-3, 71.7%; AZM-6, 73.4%; AMC, 71.3%). Subjects treated with AMC reported a higher incidence of treatment-related adverse events (AE) (51.1%) than AZM-3 (31.1%, P < 0.001) or AZM-6 (37.6%, P < 0.001). More AMC subjects discontinued the study (n = 28) than AZM-3 (n = 7) and AZM-6 (n = 11) subjects. Diarrhea was the most frequent treatment-related AE. AZM-3 and AZM-6 were each equivalent in efficacy and better tolerated than AMC for ABS.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Patient Compliance; Sinusitis; Treatment Outcome

Concentrations of cefaclor (CFC) or amoxicillin-clavulanic acid (AMX/CA) in middle-ear fluid collected preserving the stability and clearing the cell contents has been compared to those obtained using the traditional method. Sixty-seven children with effusive otitis media were treated orally with CFC (20 mg/kg of body weight) or AMX/CA (20 mg/kg) (4:1 ratio). The concentrations in cell-free fluid (C-) appear higher than those in the total fluid (C+) (as assayed traditionally).

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Area Under Curve; Body Fluids; Cefaclor; Cephalosporins; Child; Child, Preschool; Chromatography, High Pressure Liquid; Drug Therapy, Combination; Ear, Middle; Female; Humans; Male

Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged < or =2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged < or =2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged < or =2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Patient Compliance; Penicillins; Recurrence; Treatment Outcome

In 38 patients with an acute paraproctitis a new generation antibiotic Amoxiclave, owing broad spectrum of activity, was applied. While observing the wound clearance and healing process, together with clinical parameters, the results of bacteriological investigation were controlled. High efficacy of the preparation was observed as well as expediency of its application in the purulent wound surgery, for an acute paraproctitis in particular.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Proctitis

In order to meet the evolution of pneumococcus resistance to beta-lactam antibiotics, a new formulation of amoxicillin (AMX) and clavulanic acid (CA), with twice as much AMX (1 g/125 mg vs. 500 mg/125 mg) was developed for the treatment of acute pneumonia in patients at risk. This formulation can also be used in the treatment of acute maxillary sinusitis using a 1 g/125 mg regimen twice-daily.. Compare the sinusal penetration of AMX and CA (1 g/125 mg twice-daily vs. 500 mg/125 mg three times a day) when administered at both regimens to demonstrate equivalent pharmacokinetic and pharmacodynamic behaviour of the former when compared to the latter.. Concentrations of AMX and CA were measured in the anterior ethmoid, maxillary, posterior ethmoid sinus and in the middle nasa concha in 62 patients undergoing surgery for nasosinusal polyps. Patients randomised in two groups corresponding to 2 oral regimens, received either 1 g/125 mg twice a day or 500 mg/125 mg three times a day for 4 days. The last dose in both groups was administered 1 h 30, 3, 5 or 8 hrs prior to surgery. Serum samples were taken simultaneously to tissue samples. AMX and CA were measured by high performance liquid chromatography. Exogenous and above all endogenous blood contamination were taken into account with the hematocrit as well as blood and tissue haemoglobin concentrations. Comparisons of tissue concentrations were made for each sampling time, according to values obtained for a specific tissue with both doses on one hand, and on the other to values obtained with a specific dose in different tissues. The calculated pharmacodynamic parameters, which are considered to be predictive for bacteriological and clinical efficacy, result directly from tissue concentrations of AMX. tissue inhibitory quotients (IQtissue = Tissue concentration/MIC). time above MICs for serum and tissue concentrations (T > MIC).. As regards AMX, whatever the dose, at 1 h 30 and at 3 hrs, tissue concentrations did not differ significantly whatever the tissue studied (from 1.1 to 2.5 micrograms/g). Conversely, at 5 and 8 hrs, they were greater than after the 1 g/125 mg regimen given twice-daily (0.06-0.7 vs. 0.7-1.8 micrograms/g). If we consider a given dose, the comparison between the various tissues showed identical concentrations in the four tissues studied at each sampling time, except in two cases with the dose of 500 mg/125 mg 3 times a day. T > MIC for serum and tissue showed higher values than those required for AMX/pneumococcus association (40-50%) with, nevertheless, greater tissue values for the 1 g/125 mg dose given twice-daily when MIC was of 1 microgram/ml (40-52% vs. 50-66%). The maximum tissue inhibitory quotients were also greater with the twice-daily 1 g/125 mg dose, when calculated with MIC 50 or 90 of S. Pneumoniae, H. influenzae, M. catarrhalis or S. pyogenes. As for CA, concentrations were equivalent for both doses at each sampling time and greater than those required in vitro during respectively 4 and 5 hours for beta-lactamases H. influenzae and M. catarrhalis.. A least an equivalence between both dose regimens was observed, with occasionally a superiority of the twice-daily 1 g/125 mg dose, in terms of pharmacokinetics, tissue penetration and pharmacodynamics for both AMX and CA. This new regimen therefore appears more appropriate for the treatment of acute maxillary sinusitis in adults.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Chemistry, Pharmaceutical; Drug Therapy, Combination; Ethmoid Sinus; Female; Humans; Male; Maxillary Sinus; Maxillary Sinusitis; Middle Aged; Paranasal Sinuses; Time Factors; Turbinates

To assess the equivalence of amoxicillin/clavulanic acid and placebo in the prevention of acute otitis media in children at high risk of acute otitis media who develop upper respiratory tract infection.. This was a multicentre, equivalence, randomized, double-blind trial of two parallel groups comparing 5 days of amoxicillin/clavulanic acid 75 mg kg-1 day-1 (i.e. 25 mg kg-1 every 8 h) and placebo. The main outcome measure was acute otitis media occurring within 8-12 days of initiating treatment.. Two hundred and three infants, aged 3 months-3 years with upper respiratory tract infection over 36 h and a history of recurrent acute otitis media were included over 8.5 months. Two children were lost to follow-up. Patient characteristics were similar in both groups. In the intention to treat analysis the frequency of acute otitis media was 16.2% (16/99) in the placebo group and 9.6% (10/104) in the amoxicillin/clavulanic acid group (P = 0.288). The difference between acute otitis media rates was 6.6% (one-sided 95% confidence interval of 14.3%). The occurrence of side-effects was similar in the amoxicillin/clavulanic acid and placebo groups.. The difference in effectiveness between antibiotic and placebo was not greater than 14.3%, and we calculated that 94 children would need to be exposed to antibiotics to avoid six cases of acute otitis media. In view of the risk of development of resistance due to frequent exposure to antibiotics, our study supports the need for reduction in the administration of antibiotics in upper respiratory tract infection even in children at high risk of acute otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Humans; Infant; Otitis Media; Recurrence; Respiratory Tract Infections; Risk Factors; Treatment Outcome; Virus Diseases

Otorrhea occurs in 21 to 50% of all children with tympanostomy tubes in the United States. More than 1 million children annually undergo tubomyringotomy, constituting placement of more than 2 million tympanostomy tubes each year. The organisms typically responsible for otorrhea are the same as those that cause otitis media in very young children, including Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis. Drainage from tympanostomy tubes in older children involves organisms that colonize the external auditory canal, the most common being Pseudomonas aeruginosa and Staphylococcus aureus. Ofloxacin (Floxin otic), a newer fluoroquinalone antibiotic, has several advantages over other agents available for the treatment of otorrhea caused by acute otitis media in patients with tympanostomy tubes. The twice daily dosing regimen encourages better patient adherence to therapy, which is likely to improve treatment efficacy. Ofloxacin has not been associated with ototoxicity in animal models or in children participating in the clinical trials. It provides coverages for a wide range of pathogens, including Pseudomonas sp., and is indicated for use in children > or =1 year old and currently approved for patients > or =12 years with chronic suppurative otitis media. Ofloxacin applied topically in children with tympanostomy tubes in place and purulent otorrhea is as efficacious as oral amoxicillin/clavulanate (Augmentin) therapy. Other currently available therapeutic options are discussed.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Middle Ear Ventilation; Ofloxacin; Otitis Media, Suppurative; Pseudomonas; Treatment Outcome; United States

Clarithromycin has established efficacy and safety in the treatment of respiratory infections.. This study examined the efficacy and safety of a new extended-release formulation of clarithromycin compared with amoxicillin/clavulanate in the treatment of acute exacerbation of chronic bronchitis (AECB).. This phase IIIB, multicenter, randomized, parallel-group, investigator-blinded study in patients with AECB and productive cough with purulent sputum compared treatment with extended-release clarithromycin (two 500-mg tablets once daily for 7 days) and amoxicillin/clavulanate (one 875-mg tablet twice daily for 10 days). Assessments were performed before treatment, between study days 10 and 12 (or within 48 hours after premature discontinuation), and between study days 17 and 21 (test of cure).. Of 287 patients randomized and treated, 270 were clinically evaluable (137 clarithromycin, 133 amoxicillin/clavulanate). Treatment groups were well matched in terms of demographic characteristics, medical condition, and history. Among clinically evaluable patients at test of cure, 85% and 87% of clarithromycin- and amoxicillin/clavulanate-treated patients, respectively, demonstrated clinical cure (as defined in 1998 draft US Food and Drug Administration guidelines); among clinically and bacteriologically evaluable patients, 92% versus 89%, respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were similar in the 2 groups (88% clarithromycin, 89% amoxicillin/clavulanate). Rates of premature discontinuation of study drug for any reason differed between treatments: 3% (4/142) of clarithromycin-treated patients versus 12% (17/145) of amoxicillin/clavulanate-treated patients (P = 0.005). One percent (2/142) and 6% (8/145) of the respective treatment groups discontinued study drug because of adverse events. Adverse events generally occurred with a similar frequency in the 2 groups; however, taste alteration was more common with clarithromycin (9/142 [6%]) than with amoxicillin/clavulanate (1/145 [1%]; P = 0.01). Mean severity scores for gastrointestinal adverse events showed a significant difference between groups (1.16 for clarithromycin-treated patients and 1.58 for amoxicillin/clavulanate-treated patients: P = 0.016).. The results of this study demonstrate the clinical and bacteriologic equivalence and improved gastrointestinal tolerability of a 7-day course of once-daily extended-release clarithromycin relative to a 10-day course of twice-daily amoxicillin/clavulanate in the treatment of AECB.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Clarithromycin; Female; Humans; Male; Middle Aged; Tablets

Antibiotic-resistant pneumococci are difficult to eradicate from middle ear fluid (MEF) and the nasopharynx (NP). Bacteriologic eradication from the NP and MEF during acute otitis media (AOM) by 3 common antibiotic drugs was prospectively evaluated. In 19 (16%) of 119 MEF culture-positive patients, an organism susceptible to the treatment drug (Haemophilus influenzae, Streptococcus pneumoniae, or both) was isolated from the initial MEF, whereas resistant S. pneumoniae was present in the NP; in 9 (47%) patients, the initial resistant NP organism (identified by serotyping, resistance to the administered drug, and pulsed-field gel electrophoresis) replaced the susceptible MEF organism within only a few days after initiation of treatment. In regions where resistant pneumococci are prevalent, antibiotics may not only fail to eradicate the organisms, but they may often induce MEF superinfection with resistant pneumococci initially carried in the NP. This is an important mechanism by which, in recently treated patients, AOM infections often become refractory to treatment.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Drug Resistance, Microbial; Drug Therapy, Combination; Ear, Middle; Female; Humans; Male; Nasopharynx; Otitis Media; Pneumococcal Infections; Serotyping; Streptococcus pneumoniae; Superinfection; Time Factors; Trimethoprim, Sulfamethoxazole Drug Combination

The recommendation of the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group that high-dose amoxicillin, with or without clavulanate, be used to treat acute otitis media (AOM) addressed concerns about the efficacy of existing therapies against drug-resistant S. pneumoniae. This recommendation relied on pharmacodynamic predictions of concentrations of amoxicillin in middle-ear fluid remaining higher than minimum inhibitory concentrations against intermediately resistant S. pneumoniae for >40% of the dosing interval.. This study compared the tolerability and efficacy of cefprozil and high-dose amoxicillin/clavulanate in patients with AOM.. Patients were randomized to receive 10 days of investigator-blinded oral treatment with either cefprozil suspension (30 mg/kg/d in 2 divided doses) or amoxicillin/clavulanate (45/6.4 mg/kg/d) plus amoxicillin (45 mg/kg/d) in 2 divided doses. The primary efficacy end point was the clinical cure rate 4 to 7 days after the end of treatment. Clinical response by age (6 months-<2 years vs > or =2-7 years), disease severity, and unilateral versus bilateral ear infection was also examined. The primary measures of tolerability were the frequency and severity of adverse events and their relation to study drug. Adverse events were either spontaneously reported or elicited during examination and questioning of the patient. Identified adverse events were coded and recorded using the COSTART (Coding Symbols for Thesaurus of Adverse Reaction Terms) system.. Three hundred four children between the ages of 6 months and 7 years with > or =1 sign or symptom of AOM were enrolled in the study, and 303 (150 cefprozil, 153 amoxicillin/clavulanate) were treated. Twenty-three patients in each treatment group were not evaluable; thus, 257 children were included in the analysis of evaluable patients. Clinical cure rates were 87% (110/127) with cefprozil and 89% (116/130) with amoxicillin/clavulanate (95% CI for the difference in cure rate, -10.7% to 4.1%). No between-group differences in efficacy were noted by age, disease severity, or unilateral or bilateral involvement. The overall incidence of drug-related adverse events was significantly lower with cefprozil than with amoxicillin/clavulanate (19% vs 32%, respectively; P = 0.008), as was the incidence of diarrhea (9% vs 19%, respectively; P = 0.021). Adverse events prompted discontinuation of therapy in 4 (3%) cefprozil patients and 8 (5%) amoxicillin/clavulanate patients.. Based on a search of MEDLINE, this study is the first direct comparison of cefprozil versus high-dose amoxicillin/clavulanate. Cefprozil was as effective as high-dose amoxicillin/clavulanate, with a lower incidence of adverse events.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefprozil; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Drug Tolerance; Female; Humans; Infant; Male; Otitis Media; Single-Blind Method

Although antimicrobial treatment for children with acute sinusitis is used commonly, it is unclear whether it offers significant clinical benefit. The purpose of this study was to evaluate the effectiveness of antimicrobial treatments for acute sinusitis as they are used in community pediatric practice.. We conducted a randomized, placebo-controlled trial in 3 community pediatric practices in St Louis, Missouri. A total of 188 patients who were between the ages of 1 and 18 years and who had had 10 to 28 days of persistent sinus symptoms and a clinical diagnosis of acute sinusitis were randomized to receive 14 days of amoxicillin (40 mg/kg/d in 3 daily doses), amoxicillin-clavulanate (amoxicillin 45 mg/kg/d in 2 daily doses), or placebo. Change in sinus symptoms was assessed both by a quantitative symptom score (the S5 score) and subjectively by the parent. Secondary outcomes included adverse effects of treatment and recurrence or relapse of sinus symptoms. Outcomes were assessed by telephone interviews over a 2-month period.. Of the 161 patients who were included in the analysis, 58 received amoxicillin, 48 received amoxicillin-clavulanate, and 55 received placebo. Day 14 improvement rates were 79%, 81%, and 79%, respectively. There were no differences in the 14-day change in S5 score among treatment groups. The rates of adverse events (amoxicillin, 19%; amoxicillin-clavulanate, 11%; placebo, 10%), relapse (amoxicillin, 12%; amoxicillin-clavulanate, 13%; placebo, 13%), and recurrence (amoxicillin, 9%; amoxicillin-clavulanate, 13%; placebo, 13%) of sinus symptoms were similar among treatment groups.. Neither amoxicillin nor amoxicillin-clavulanate offered any clinical benefit compared with placebo for children with clinically diagnosed acute sinusitis.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Humans; Infant; Placebos; Sinusitis; Treatment Outcome

To evaluate if the extent of normal microflora disturbances differed between treatment with amoxycillin-clavulanate administered in an active form and cefuroxime axetil administered as an inactive prodrug.. Twenty-eight children, 0.5-5 years old, diagnosed with acute otitis media (AOM), were treated with either amoxycillin-clavulanate (13.3 mg/kg 3 times daily) or cefuroxime axetil (15 mg/kg twice daily) for 7 days. Saliva samples and nasopharyngeal swabs were collected before, directly after and 2 weeks after treatment. The saliva samples were quantitatively and qualitatively analyzed and the nasopharyngeal swabs were qualitatively analyzed. All isolated strains were tested for beta-lactamase production.. Both treatment regimens gave rise to similar alterations of the normal oropharyngeal microflora. In both groups, the amount of Streptococcus salivarius was significantly reduced (P < 0.05). The most common causative pathogens of acute otitis were S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. On the day of enrollment, approximately half of the patients, in both groups, were infected with more than one pathogen. The rate of infection or colonization with more than one potential pathogen was low on day 7 but recurred 2 weeks after treatment to similar levels as on day 0. The total number of patients with reinfection, recolonization or recurrence of pathogens on day 21 was 11/12 in the amoxycillin-clavulanate group and 4/7 in the cefuroxime axetil group. The most common beta-lactamase producer was M. catarrhalis.. The local high concentration of antibiotics in the oropharynx immediately after intake of antibiotic suspensions seem to have little or no impact on the extent of disturbance of the microflora in this region. Children of this age group seem prone to either reinfection, recolonization or persistence of pathogens within 2 weeks after treatment. Furthermore, co-infection with more than one pathogen seems common in children with AOM and infection with beta-lactamase producing microorganisms occurs frequently.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamases; Cefuroxime; Cephalosporins; Child, Preschool; Colony Count, Microbial; Drug Therapy, Combination; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Prodrugs; Prospective Studies; Saliva

In this prospective, multicentre, randomised, non-blinded phase III clinical trial, 475 adult patients with acute sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or amoxicillin clavulanate (875 mg twice daily). The primary measure of efficacy was clinical resolution. Secondary outcome measures included clinical relapse at follow-up and evaluation of patient reported outcomes. Of 471 adults comprising the intent-to-treat population (234 moxifloxacin, 237 amoxicillin/clavulanate), moxifloxacin treatment was statistically equivalent to amoxicillin/clavulanate at the test-of-cure visit (85% vs 82%; 95% CI -6%, 13%). Analysis of the efficacy evaluable population, confirmed statistical equivalence (86% vs 84%; 95% CI -7%, 13%). Of note, by day 3 of treatment, significantly more moxifloxacin-treated patients (n = 47; 24%), than amoxicillin/clavulanate-treated patients (n = 28; 14%), reported feeling better (p < 0.02). Frequency of drug-related adverse events were similar between groups: nausea (11% moxifloxacin, 5% amoxicillin/clavulanate) and diarrhoea (3% moxifloxacin, 10% amoxicillin clavulanate). In conclusion, once-daily moxifloxacin is as effective and safe as twice-daily amoxicillin/clavulanate in the treatment of acute sinusitis. Moxifloxacin is associated with more rapid symptomatic relief.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Aza Compounds; Drug Therapy, Combination; Female; Fluoroquinolones; Humans; Male; Maxillary Sinusitis; Middle Aged; Moxifloxacin; Prospective Studies; Quinolines; Treatment Outcome

To determine the bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) against common bacterial pathogens causing acute otitis media (AOM), including penicillin-resistant Streptococcus pneumoniae (PRSP).. In this open label multicenter study, 521 infants and children with AOM [mean age, 18.6 months; age < 24 months, n = 375 (72%)] were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 days. Bilateral otitis media, previous episodes of AOM, antibiotic treatment within 3 months and day-care attendance were recorded in 60.1, 35.7, 50.2 and 38.2% of the children, respectively. Tympanocentesis was performed before the first dose and repeated on Days 4 to 6 for all children with S. pneumoniae at 22 centers and for all children with any pathogen at 3 centers. Clinical response was assessed at end of therapy.. Pathogens were isolated from 355 (68%) of 521 enrolled children; 180 children underwent repeat tympanocentesis and were bacteriologically evaluable. Baseline pathogens were S. pneumoniae (n = 122 enrolled/93 bacteriologically evaluable), Haemophilus influenzae (n = 160/51), both (n = 37/32) and others (n = 36/4). Pathogens were eradicated from 172 (96%) of 180 bacteriologically evaluable children. Overall 122 (98%) of 125 isolates of S. pneumoniae were eradicated, including 31 (91%) of 34 PRSP isolates (penicillin MICs 2 to 4 micrograms/ml). Seventy-eight (94%) of 83 isolates of H. influenzae were eradicated. Symptoms and otoscopic signs of acute inflammation were completely resolved or improved on Days 12 to 15 in 263 (89%) of 295 clinically evaluable children with bacteriologically documented AOM.. On the basis of bacteriologic outcome on Days 4 to 6 and clinical outcome on Days 12 to 15, we found that high dose amoxicillin/clavulanate (90/6.4 mg/kg/day) was highly efficacious in children with AOM, including those most likely to fail treatment, namely children < 24 months of age and those with infectious caused by PRSP.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Penicillin Resistance; Streptococcus pneumoniae; Treatment Outcome

This multicenter, randomized open-label study compared the efficacy and safety of roxithromycin tablets 300 mg once a day (Rx) and amoxicillin/clavulanic acid tablets 875+125 mg twice a day (Acx), administered for a mean of 7 days. The study was carried out in five centers on 100 in- or out-patients of both sexes, aged between 18 and 91 years (mean 38+/-14). All patients suffered from ENT diseases, 85% with acute otitis media, 31% pharyngotonsillitis and 11% rhinosinusitis. The patients were divided into two randomized groups of 50 patients each. Clinical evaluations (signs and symptoms) were performed before, during and at the end of therapy. At the end of therapy, for intent-to-treat and per-protocol populations, a satisfactory overall clinical response was achieved by 82% of patients in the Rx group and 78% in the Acx group with similar reductions in signs and symptoms of disease in both groups. Safety was good, with only 2 patients of the Rx group and 4 patients of the Acx group presenting side effects, involving mainly the gastrointestinal system. Rx appears to be active and safe in the therapy of ENT diseases exhibiting similar effects on the reduction of signs and symptoms as Amx but with better compliance because of once-a-day administration.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Resistance; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Otitis Media; Pharyngitis; Roxithromycin; Sinusitis

Exacerbations of chronic obstructive pulmonary disease (COPD) have an inflammatory component in addition to the possible infectious component. The antiinflammatory properties of fenspiride (Pneumorel(R) 80 mg) should be evaluated in this frequent clinical situation.. Assess the supplementary therapeutic benefit provided by fenspiride administered in combination with antibiotics in COPD patients presenting an episode of bronchial infection.. A preliminary randomized placebo-controlled double-blind study was conduced in 7 centers. Patients under 80 years of age of both sexes were included. All patients had COPD and presented a bronchial infection defined as the presence of at least 2 of the 3 criteria defined by Anthonisen. Patients were randomly assigned to group F or group P. Group F received an antibiotic therapy from day 1 to day 11 plus fenspiride (3 x 80mg/d from day 0 to day 30). Group P received the same antibiotic therapy plus placebo. Amoxicillin 500mg plus clavulanic acid 125, 3 tablets/day, was administered in both groups.. Thirty-nine patients were included (group F 19 patients, group P 20 patients; 6 women and 33 men; mean age 61.1 +/- 9.8 years). The 3 Anthonisen criteria were present in 79% and 75% of the patients in group F and P respectively (NS). On day 11, expectoration resolved in 39% and 32% (NS) and cough in 44% and 16% (NS) of the patients in groups F and P respectively. Lung auscultation returned to normal in 83% of the patients in group F compared with 47% in group P (p=0.05). A composite clinical score including expectoration cough and auscultation findings showed that 28% of the patients in group F were symptom-free on day 11 compared with 0% in group P (p=0.04). On day 30, the two groups were comparable.. In this preliminary study of patients with COPD presenting a bronchial superinfection, there was a significant improvement in lung auscultation and in the composite clinical score in patients given fenspiride. Fenspiride was thus found to provide an early clinical benefit.

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Bronchodilator Agents; Combined Modality Therapy; Cyclooxygenase Inhibitors; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prospective Studies; Spiro Compounds; Treatment Outcome

Augmentin was used prophylactically in 25 patients with an account of the infectious complication risk according to 4 regimens: ultrashort-term (1.2 g intravenously with initial narcosis), short-term (1.2 g intravenously with initial narcosis followed by intravenous administration in a dose of 600 mg in 8 and 16 hours), middle-term (1.2 g intravenously with initial narcosis followed by intravenous administration in a dose of 600 mg every 8 hours for 2 days) and long-term (1.2 g intravenously with initial narcosis followed by intravenous administration in a dose of 600 mg every 8 hours for 3 days). One complication episode as wound suppuration was recorded. The routine approach to the use of antibiotics in emergency abdominal surgery, when antibiotics are administered every day for several days after the operation, should be revised.

Topics: Abdomen; Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Drug Therapy, Combination; Humans; Middle Aged; Surgical Wound Infection

Augmentin (amoxycillin/clavulanate) was used in the treatment of 88 patients with mild and moderate infections of the urogenital organs. The drug was administered in a single dose of 375 mg thrice daily for 6 to 12 days. The renal function in 62 patients (70.5 per cent) was normal and in 26 patients (29.5 per cent) the chronic renal insufficiency latent stage was stated (the decrease of the glomerular filtration up to 55-70 ml/min). When augmentin was used before lithotripsy in 35 patients for 6 days, all the laboratory and clinical indices came to normal in 30 patients (85.7 per cent) and only in 4 patients (11 per cent) leukocyturia and in 1 patient bacteriuria persisted. When augmentin was used in 26 patients before adenomectomy or after transurethral resection for 7 to 9 days, all the indices came to normal in 13 patients (50 per cent) and in the other 13 patients leukocyturia persisted, while no bacteriuria was recorded. When augmentin was used in the treatment of 19 patients with pyelonephritis exacerbation during the postoperative period for 7 to 12 days, all the clinical and laboratory indices came to normal in 13 patients (68.4 per cent), leukocyturia persisted in 6 patients and bacteriuria persisted in 2 patients. When augmentin was used in the treatment of 8 patients with acute orchiepididymitis for 7 to 10 days, the clinical effect was stated in all the patients. As a rule, the drug was well tolerated by the patients.

Topics: Acute Disease; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Chronic Disease; Drug Therapy, Combination; Humans; Inflammation; Male; Male Urogenital Diseases; Middle Aged

This multicenter, randomized, single-blind study compared the efficacy and safety of a new, twice-daily formulation of amoxycillin/clavulanate (Augmenting) with the standard three-times-daily formulation. Children with a clinical diagnosis of acute otitis media, aged between 2 months and 12 years, received either amoxycillin/clavulanate 45/6.4 mg/kg/day twice-daily (b.d.) (range 38.3/5.5-76.2/10.9 mg/kg/day) or amoxycillin/clavulanate 40/10 mg/kg/day three-times-daily (t.d.s.) (range 25/6.25-56/14 mg/kg/day) for 7 or 10 days. Patients were evaluated during therapy (Days 3-5), at the end of therapy (Days 7-12) and at follow-up (Days 38-42). At the end of therapy, for the intent-to-treat and per-protocol populations, respectively, clinical success (cure) was achieved by approximately 94% of patients in both treatment groups. A successful bacteriological response at the end of therapy (Visit 3) was documented in 7/9 patients (77.8%) in the twice-daily group and in 11/13 patients (84.6%) in the three-times-daily group. At follow-up (Visit 4), 93.3% of patients in the twice-daily group and 87.9% in the three-times-daily group continued to have a clinically successful response. Both treatment regimens were well tolerated, with most adverse events being of a mild-moderate and transient nature. The most common treatment-related adverse event was diarrhea, occurring in 7.2% of patients in the twice-daily group and in 10.7% of the three-times-daily group. In total, 173 patients (82.8%) in the twice-daily group and 151 patients (73.3%) in the three-times-daily group were compliant with medication. In conclusion, this study confirms that b.d. amoxycillin/clavulanate is an effective treatment for pediatric acute otitis media and demonstrates that the b.d. and t.d.s. formulations of amoxycillin/clavulanate produce equivalent efficacy. Furthermore, there was a trend towards a higher level of compliance and a lower incidence of drug-related adverse events in the twice-daily compared with the three-times-daily treatment group.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Chemistry, Pharmaceutical; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Patient Compliance; Single-Blind Method; Treatment Outcome

The aim of this short-term open parallel longitudinal clinical study was to compare the clinical and microbiological efficacy of 2 different antibiotic regimes in the treatment of acute periodontal abscesses.. After patient selection, a clinical examination was carried out recording the following variables: pain, edema, redness, swelling, bleeding on probing, suppuration, tooth mobility, lymphadenopathy, and probing pocket depth. Microbiological samples were taken from the lesion and the patient was randomly assigned to one of two antibiotic regimes: azithromycin or amoxicillin/clavulanate. Clinical variables were recorded, and microbiological samples were taken, at 3-5 days, 10-12 days and 30 days. Additional mechanical treatment (debridement and scaling) was performed in the third visit (10-12 days). Blood and urine samples were collected at baseline and after 10-12 days. Microbiological samples were processed by anaerobic culturing, and isolated periodontal pathogens were tested for antibiotic susceptibility by means of the spiral gradient endpoint methodology.. 15 patients took azithromycin, and 14 amoxicillin/clavulanate. Subjective clinical variables demonstrated statistically significant improvements with both antibiotic regimes, which lasted for at least 1 month (p<0.01). Objective clinical variables also showed clear improvements, being statistically significant after 30 days with probing pocket depth in the azithromycin group (p<0.01). Microbiologically, short-term reductions were detected with both antibiotics, however fast recolonization occurred after the third visit. No significant differences were found between both treatment regimes. Antibiotic susceptibilities demonstrated no resistances for amoxicillin/clavulanate, while 2-3 strains of each studied pathogen were resistant to azithromycin.. However, both antibiotic regimes were effective in the short-term treatment of periodontal abscesses in periodontitis patients.

Topics: Acute Disease; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Periodontal Abscess; Statistics, Nonparametric; Time Factors; Treatment Outcome

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Maxillary Sinusitis; Middle Aged; Pneumococcal Infections; Treatment Outcome

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Treatment Outcome

Two dosage regimens of cefdinir were compared with amoxicillin/clavulanate for the treatment of suppurative acute otitis media (AOM) in children.. This was an investigator-blinded, randomized, comparative, multicenter trial, in which tympanocentesis was performed in 384 patients, ages 6 months to 12 years, who had nonrefractory AOM. Patients were randomized to receive one of three 10-day treatment regimens: cefdinir 14 mg/kg daily (QD; n = 128); cefdinir 7 mg/kg twice a day (BID; n = 128); or amoxicillin/clavulanate 40/10 mg/kg/day divided for use three times a day (TID; n = 128).. Of the 384 enrolled patients 303 were evaluable for clinical efficacy. Clinical success rates were statistically equivalent for the 3 treatment groups at the end of therapy: 85 of 102 (83.3%) for cefdinir QD; 81 of 101 (80.2%) for cefdinir BID; 86 of 100 (86%) for amoxicillin/clavulanate. Of the 197 evaluable patients from whom a susceptible pathogen was recovered, presumptive eradication rates at end of therapy were equivalent: 55 of 65 (84.6%), 54 of 66 (81.8%) and 55 of 66 (83.3%) for cefdinir QD-, cefdinir BID- and amoxicillin/clavulanate-treated patients, respectively. However, presumptive eradication rates for Streptococcus pneumoniae were significantly lower for cefdinir BID (55.2%) than for amoxicillin/clavulanate (89.5%; P = 0.0019) and marginally lower than for cefdinir QD (80%; P = 0.054). Diarrhea was the most common treatment-associated adverse reaction in all groups but was significantly more common in amoxicillin/clavulanate-treated patients (35%) than in patients who had been treated with cefdinir QD (10%, P<0.001) or cefdinir BID (13%, P<0.001).. A 10-day regimen of cefdinir 14 mg/kg QD or 7 mg/kg BID was as clinically effective overall as a 10-day regimen of amoxicillin/ clavulanate 40/10 mg/kg/day divided TID in the treatment of tympanocentesis-confirmed, nonrefractory AOM in children. These data suggest that cefdinir QD may be a better alternative than cefdinir BID for refractory AOM. Both dosing regimens of cefdinir were associated with significantly fewer gastrointestinal adverse reactions than was amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media, Suppurative; Treatment Outcome

An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/ clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days posttherapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cefdinir; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media, Suppurative; Treatment Outcome

Evolution of bacterial resistance shortens antibiotic treatment in ENT infections. The efficacy and tolerance of amoxicillin-clavulanate (ACA), with and without associated short steroid therapy, was evaluated in acute sinusitis of adults at a dosage of 1.5 g/d for 5 d vs. 10 d. This multicentre, randomized, double-blind, placebo-controlled study included 433 patients, 417 of whom were suitable for intent-to-treat (ITT) analysis. The therapeutic success rate in the ITT population, assessed according to strict clinical and radiological criteria, was respectively, 80% and 85% in the 5-d and 10-d treatment groups. Due to the statistical risks that were evidenced, the 2 durations of treatment could not be considered equivalent. The analysis of medical history shows that some risk factors (recurrence of sinusitis, previous surgical sinus drainage) seem to promote therapeutic failure and that 5-d treatment is inappropriate in these patients. The persistence of therapeutic success on day 30 was not influenced by the initial duration of treatment. The efficacy and good tolerance of ACA in acute sinusitis in adults were confirmed. Further studies will be needed to define the indications of short treatments better, which seem to be indicated in the absence of specific risk factors.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Inflammatory Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Methylprednisolone; Middle Aged; Risk Factors; Sinusitis; Time Factors; Treatment Outcome

In this comparative trial, outpatients with acute sinusitis were randomly assigned to receive levofloxacin (500 mg orally once daily) or amoxicillin-clavulanate (500/125 mg orally 3 times daily) for 10 to 14 days. The success rates (cured and improved) 2 to 5 days after the end of treatment were 88.4% for the 267 clinically evaluable patients who received levofloxacin and 87.3% for the 268 clinically evaluable patients who received amoxicillin-clavulanate. Drug-related adverse events occurred in a smaller percentage of patients in the levofloxacin treatment group (7.4%) than in the amoxicillin-clavulanate treatment group (21.2%). The most common of these were nausea, diarrhea, vaginitis, and abdominal pain for levofloxacin-treated patients and diarrhea, vaginitis, nausea, genital moniliasis, abdominal pain, vomiting, and flatulence for amoxicillin-clavulanate-treated patients. The results of this study show that once-daily administration of levofloxacin is as effective and better tolerated than amoxicillin-clavulanate administered 3 times daily for treating acute sinusitis in adult outpatients.

Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Drug Therapy, Combination; Female; Gastrointestinal Diseases; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Sinusitis; Treatment Outcome; Vaginitis

To compare the efficacy and the safety of a single intramuscular dose of ceftriaxone, 50 mg/kg, vs. a 10-day course of amoxicillin/clavulanate (amox/clav) therapy, 80 mg/kg/day of amoxicillin: 10 mg/kg/day of clavulanate in three divided doses, in children with acute otitis media (AOM) and to evaluate the changes in nasopharyngeal flora after treatment.. In a prospective, comparative, open randomized, multicenter trial, children were scheduled to return for visits on Days 12 to 14 (main end point) and Days 28 to 42 after the beginning of treatment for AOM. A nasopharyngeal swab for bacterial culture was obtained before the treatment and at Days 12 to 14.. Between February, 1995, and May, 1996, 513 children with a mean age of 14.2 +/- 6.7 months were enrolled. All the patients were evaluable for the safety and intent-to-treat analyses and 463 for the per protocol efficacy. At Days 12 to 14 clinical success was obtained in 186 of the 235 children (79%) given ceftriaxone and in 188 of the 228 children (82.5%) treated with amox/clav. Among the patients with clinical success on Days 12 to 14, the success was maintained at Days 28 to 42 for 108 of 183 (59%) patients in the ceftriaxone group and 103 of 187 (55%) patients in the amox/clav group. Before the antibiotic treatment the percentages of children carrying Streptococcus pneumoniae (59.1%), Haemophilus influenzae (39.4%), Moraxella catarrhalis (55.7%) and the rate of penicillin-resistant S. pneumoniae (52.2%) were comparable between the 2 groups. At Days 12 to 14 the carriage of S. pneumoniae and M. catarrhalis was significantly different between the patients treated with ceftriaxone, 43.9 and 42.2, respectively, and the patients treated with amox/clav, 17.4 and 11.1%, respectively. Among the children carrying S. pneumoniae at Days 12 to 14, the percentage of penicillin-resistant strains reached 63.4% in the ceftriaxone treatment group and 83.0% in the amox/clav treatment group, (P = 0.02). Adverse events (mainly diarrhea) related to the study medication were reported more frequently (P < 0.0001) in the amox/clav treatment group.. In an area with a high rate of penicillin-resistant S. pneumoniae, a single dose of ceftriaxone is as efficient as a 10-day course of amox/clav in the treatment of AOM in young children. There was for the two regimens an increased rate of penicillin-resistant strains among the pneumococci carried, whereas the chance for a child to carry a penicillin resistant S. pneumoniae did not increase after treatment.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Cephalosporins; Child, Preschool; Drug Administration Schedule; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Nasopharynx; Otitis Media with Effusion; Prospective Studies; Streptococcus pneumoniae; Treatment Outcome

A comparative trial was performed of two regimens of antibiotic therapy in acute otitis, exacerbation of otitis media chronica and sinusitis in children. 100 children received combined treatment with amoxycilline and clavulanic acid (amoxiclav and autmentin). 50 control children were i.m. injected ampicilline. Oral co-amoxiclavs proved highly effective in ENT diseases in children and are superior to intramuscular ampicilline.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Child; Chronic Disease; Drug Administration Routes; Drug Therapy, Combination; Follow-Up Studies; Humans; Otitis Media; Penicillins; Retrospective Studies; Sinusitis; Treatment Outcome

This double-masked, multicenter, randomized clinical trial compared the efficacy and tolerability of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial maxillary sinusitis. A total of 263 patients with acute bacterial maxillary sinusitis were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (n = 132) or amoxicillin/clavulanate 500/125 mg 3 times daily (n = 131). Patients' responses to treatment were assessed once during treatment (6 to 8 days after the start of treatment), at the end of treatment (1 to 3 days posttreatment), and at follow-up (26 to 30 days after cessation of treatment). Clinical success, defined as cure or improvement, was equivalent in the cefuroxime axetil and amoxicillin/ clavulanate groups at the end-of-treatment and follow-up assessments. Patients in both groups showed improvements in symptoms of acute sinusitis at the during-treatment visit. Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than treatment with cefuroxime axetil (29% vs 17%), primarily reflecting a higher incidence of gastrointestinal adverse events (23% vs 11%), particularly diarrhea. Two patients in the cefuroxime axetil group and 8 patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events (P = 0.06). These results indicate that cefuroxime axetil 250 mg twice daily is as effective as amoxicillin/clavulanate 500 mg 3 times daily in the treatment of acute sinusitis and produces fewer gastrointestinal adverse events. cefuroxime axetil, amoxicillin/clavulanate, acute sinusitis.

Topics: Acute Disease; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Cefuroxime; Cephalosporins; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Maxillary Sinusitis; Middle Aged; Patient Dropouts

A multinational, multicentre, randomized, prospective, parallel-group study compared treatment with ciprofloxacin administered as an oral suspension (500 mg twice daily for 7 days) with co-amoxiclav tablets (625 mg three times daily for 7 days) in patients suffering from acute exacerbations of chronic bronchitis (AECB). A total of 147 of 165 cases treated with ciprofloxacin (89.1%) and 146 of 162 cases treated with co-amoxiclav (90.1%) were classified as being clinical successes at the primary efficacy assessment 7 days after the end of therapy (assessed as reduced cough, improvement in dyspnoea, reduction in 24-h sputum volume or reduced purulence of sputum). Treatment equivalence was statistically confirmed; treatment difference:--1.0%, 95% CI--6.6% and 4.5%. Before treatment, 128 bacterial strains were isolated from 103 patients (60 ciprofloxacin and 68 co-amoxiclav). The most commonly isolated organism was Haemophilus influenzae (60 isolates), followed by Moraxella catarrhalis (12 isolates), Streptococcus pneumoniae (11 isolates) and Staphylococcus aureus (10 isolates). At day 14, 40 of 46 ciprofloxacin-treated patients (87.0%) and 46 of 55 co-amoxiclav-treated patients (83.6%) who were valid for bacteriological analysis were classified as being bacteriological success (classed as eradication, eradication with colonization or presumed eradication; treatment difference: 3.3%, 95% CI--8.3% and 14.9%). The adverse event profile was comparable between treatment groups. Most adverse events considered possibly or probably related to study drug were related to the gastrointestinal system and were of mild or moderate severity: nausea (13% ciprofloxacin, 10.6% co-amoxiclav), flatulence (10.3% ciprofloxacin, 3.9% co-amoxiclav), abdominal pain (7.6% ciprofloxacin, 7.3% co-amoxiclav) and diarrhoea (4.3% ciprofloxacin, 6.7% co-amoxiclav). We concluded that a 7-day course of ciprofloxacin suspension is equivalent to a 7-day course of co-amoxiclav tablets in terms of clinical and bacteriological efficacy and tolerability for the treatment of AECB. Thus, ciprofloxacin suspension may offer a suitable alternative treatment for AECB patients who have difficulty in swallowing, or who prefer liquid medications to tablets.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bronchitis; Ciprofloxacin; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Tablets; Treatment Outcome

Otitis media is a common infection of childhood. Increasing antibiotic resistance rates among the principal causative pathogens, Streptococcus pneumoniae and Haemophilus influenzae, are associated with failure of first line agents.. This open, randomized, multicenter study compared the clinical efficacy of a short 5-day course of cefuroxime axetil (CAE) suspension with that of amoxicillin/clavulanate (A/CA) suspension for 8 or 10 days.. Children age 6 to 36 months with acute otitis media with effusion, diagnosed by tympanocentesis and microbiologic culture, were randomized to receive CAE (30 mg/kg/day in two divided doses for 5 days) or A/CA 40 mg/kg/day in three divided doses for 10 days (A/CA-10). In French centers A/CA was given at 80 mg/kg/day in three divided doses for 8 days (A/CA-8). Patients were assessed 1 to 4 days after completing the course (posttreatment) and followed up at 21 to 28 days after completing the course.. Of the 716 patients randomized, 252 were treated with CAE, 255 with A/CA-10 and 209 with A/CA-8. In the clinically evaluable population, the proportions of patients with clinical cure at posttreatment were 175 of 203 (86%), 181 of 205 (88%) and 145 of 164 (88%) in the CAE, A/CA-10 and A/CA-8 groups, respectively, demonstrating equivalence among the three treatments. For patients <18 months old, clinical cures were 111 of 134 (83%), 116 of 131 (89%) and 83 of 99 (84%) in the CAE, A/CA-10 and A/CA-8 groups, respectively; equivalence was also demonstrated. At follow-up, 130 of 175 (74%) CAE, 121 of 172 (70%) A/CA-10, and 112 of 142 (79%) A/CA-8 had maintained cure. A total of 837 pretreatment pathogens were isolated from middle ear fluid in 73% (522 of 716) patients, the majority of isolates were S. pneumoniae (30%) and H. influenzae (27%). The most common adverse events were gastrointestinal, the incidence of drug-related diarrhea being higher in the A/CA-10 group (18%) than in either the CAE or A/CA-8 groups (10%).. A 5-day course of CAE, given twice daily, was shown to be equivalent to the two regimens of A/CA for treatment of acute otitis media with effusion in children.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefuroxime; Cephalosporins; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Treatment Outcome

A randomized study of a 3-day course of azithromycin therapy (500 mg once daily) vs. a 10-day course of co-amoxiclav therapy (625 mg thrice daily) in patients with acute sinusitis was performed with an account of the GCP criteria. One hundred patients in 2 groups each of 50 persons were enrolled. The estimates of the patient body temperature, headache, pain on palpation in the area of the accessory nasal sinuses, nasal cavity stuffing, nasal discharge nature and the nose mucous membrane appearance were recorded prior to the treatment, in 72 hours and on the 10th-12th and 26th-30th days of the treatment. The microbiological analysis of the punctate from the accessory nasal sinuses was undertaken before the antibiotic therapy and 72 hours after its start. The economic analysis included the cost of the antibiotic therapy course, hospitalization term, medical manipulations and laboratory tests as well as the cost/efficacy index. The frequency of the relapses within 6 months after the cure was estimated in the two groups compared. In 72 hours and on the 10th-12th days after the treatment start the efficacy of azithromycin was significantly higher than that of co-amoxiclav. The cure was stated in 41 (82 per cent) and 26 (52 per cent) patients on the 10th-12th days, in 6 (12 per cent) and 21 (42 per cent) patients the improvement was stated and the fail was stated in 3 (6 per cent) and 2 (4 per cent) patients respectively. The efficacy of the drugs on the 26th-30th days after the treatment start did not differ. The isolates of Staphylococcus aureus and Streptococcus pyogenes were the main pathogens. The bacteriologic eradication was recorded in 29 (90.6 per cent) patients treated with azithromycin and only in 18 (69.2 per cent) patients treated with co-amoxiclav. Adverse reactions and relapses of the disease within 6 months after the cure were more frequent in the patients treated with co-amoxiclav. The cost of the azithromycin therapy was significantly lower. It was shown that the shortened course of the azithromycin therapy provided earlier cure of the patients with acute sinusitis, better tolerance of the drug, less frequent adverse reactions, lower cost as compared to the use of co-amoxiclav and no relapses.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bacteria; Bacterial Infections; Costs and Cost Analysis; Drug Therapy, Combination; Female; Humans; Male; Sinusitis; Time Factors

To investigate the validity of a short-term course of azitromycin in acute sinusitis (AS). Comparison of clinical and bacteriological effects, tolerance of azitromycin and co-amoxiclav.. 50 AS patients were given a single 500 mg daily dose of axitromycin for 3 days and 50 such patients received co-amoxiclav 625 mg 3 times a day for 10 days. The examination performed before the treatment, 72 hours, 10-12 and 26-30 days after its beginning assessed the presence of fever, head ache, pain at palpation at the site of the sinuses projection, nasal breathing and discharge. X-ray examination and microbiological analysis of the puncture biopsy from the nasal sinuses were conducted before treatment and on its day 10-12.. On the treatment hour 72 and day 10-12 azitromycin efficiency was significantly higher than that of co-amoxiclav. Recovery on the treatment day 10-12 was registered in 41(82%) and 26(52%) patients, improvement--in 6(12%) and 21(42%), no effect--in 3(6%) and 2(4%) patients, respectively, for azitromycin and co-amoxiklav. On the treatment days 26-30, 45 and 43 patients recovered, respectively. The causative agents were mainly S.aureus and Str.pyogenes. Eradication of the pathogens in response to azitromycin occurred in 29, to co-amoxiclav in 18 patients. The latter caused side effects more frequently.. Azitromycin vs. co-amoxiclav provides cure in acute sinusitis for a shorter time, is better tolerated and less toxic.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Biopsy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Radiography; Sinusitis; Treatment Outcome

Treatments with once-daily trovafloxacin (200 or 100 mg) and amoxicillin/clavulanic acid (500/125 mg three times daily) were compared in adults with acute exacerbations of chronic obstructive bronchitis. At end of treatment, 95% (113/119) of clinically evaluable patients receiving trovafloxacin 200 mg, 98% (113/115) of patients treated with trovafloxacin 100 mg and 97% (113/117) of patients receiving amoxicillin/clavulanic acid were cured or improved. At study end, 91%, 87% and 88%, respectively, were cured or improved. At end of treatment, trovafloxacin 200 mg eradicated Haemophilus influenzae in 97% of patients, Streptococcus pneumoniae in 90% and Chlamydia pneumoniae in 100%. The respective eradication rates for trovafloxacin 100 mg were 84%, 100% and 100%; those for amoxicillin/clavulanic acid were 92%, 100% and 100%. At study end, trovafloxacin 200 mg totally eradicated all three pathogens. Trovafloxacin 100 mg eradicated Haemophilus influenzae in 91% of patients, Streptococcus pneumoniae in 100% and Chlamydia pneumoniae in 80%. Respective eradication rates for amoxicillin/clavulanic acid were 78%, 100% and 80%. Only 7% (10/144) of patients receiving trovafloxacin 200 mg reported treatment-related adverse events, as did 7% (10/135) of patients given trovafloxacin 100 mg and 12% (17/140) of patients given amoxicillin/clavulanic acid.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Bronchitis; Chlamydia Infections; Chronic Disease; Drug Therapy, Combination; Female; Fluoroquinolones; Haemophilus Infections; Humans; Male; Middle Aged; Naphthyridines; Pneumococcal Infections

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Diarrhea; Double-Blind Method; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Gastroenteritis; Humans; Infant; Male; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

In this randomized, multicenter, observer-blind study, the efficacy, safety and tolerability of amoxycillin/clavulanate and cefaclor were compared in children with a clinical diagnosis of acute otitis media. Patients aged between 1 and 12 years received either amoxycillin/clavulanate (250 mg/62 mg t.i.d., or 125 mg/31 mg t.i.d. if aged under 6 years) or cefaclor (250 mg t.i.d., or 125 mg t.i.d. if aged under 6 years) for 7 days. The amoxycillin/clavulanate regimen was based on a dose of 20/5 mg/kg/day (representing 20 mg amoxycillin plus 5 mg clavulanic acid) in three divided doses. Patients were followed-up at the end of therapy and on days 10-12 and 38-40. At the end of the study (days 38-40), clinical success rates were 91.4% for amoxycillin/clavulanate and 78.6% for cefaclor. The difference was statistically significant (p = 0.008). After the 7 days of treatment, 3 patients (2.9%) in the amoxycillin/clavulanate group had clinical failure, compared with 18 patients (16.1%) in the cefaclor group (p < 0.001). Both treatments were well tolerated and there were no statistically significant differences between the groups in adverse event profiles. The incidence of diarrhea was low (7.0% amoxycillin/clavulanate, 8.4% cefaclor) and was generally of mild or moderate intensity. The study demonstrated that amoxycillin/clavulanate was significantly more effective clinically than cefaclor in the treatment of acute otitis media in children.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Single-Blind Method; Treatment Outcome

Acute otitis media (AOM) in children with tympanostomy tubes in place typically presents with otorrhea (draining ear). Because therapy is not standardized, various topical and systemic antibiotics of unproven efficacy and safety have been used in this indication. This study compared the safety and efficacy of ofloxacin otic solution, 0.3% (OFLX) with that of Augmentin oral suspension (AUG) in pediatric subjects 1-12 years of age with tympanostomy tubes and acute purulent otorrhea. Subjects were randomized to receive 10d of OFLX, 0.25 ml topically bid, or of AUG, 40 mg/kg per day. Audiometry was performed in subjects > or =4 years of age. Overall cure rate for clinically evaluable subjects was 76% with OFLX (n = 140) and 69% with AUG (n = 146; P = 0.169). Overall eradication rates for OFLX and AUG were similar for Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis and were superior with OFLX for Staphylococcus aureus and Pseudomonas aeruginosa (P<0.05 for both). OFLX had a greater overall pathogen eradication rate (96% vs. 67%; P<0.001). Treatment-related adverse event rates were 31% for AUG and 6% for OFLX (P<0.001). Neither treatment significantly altered hearing acuity. Topical ofloxacin 0.3% otic solution 0.25 ml bid was as effective and better tolerated than systemic therapy with Augmentin oral suspension 40 mg/kg per day in treating AOM in children with tympanostomy tubes.

Topics: Acute Disease; Administration, Oral; Administration, Topical; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Audiometry; Bacterial Infections; Child, Preschool; Drug Therapy, Combination; Female; Humans; Male; Middle Ear Ventilation; Ofloxacin; Otitis Media, Suppurative

Use of a beta-lactamase stable antibiotic is called for in cases of acute otitis media (AOM) likely to be caused by beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis. Two beta-lactamase-stable agents commonly used for empirical treatment of AOM are amoxicillin/clavulanate and cefixime.. A multicenter, randomized clinical trial compared cefixime (CFX; 8 mg/kg once daily) with amoxicillin/clavulanate (A/C; 40 mg/kg/day in three divided doses) for the treatment of children with AOM. Three hundred thirteen children were randomly assigned to a 10-day course of either CFX (n = 158) or A/C (n = 155). Based on history, physical examinations and otoscopic and tympanometric assessments, clinical responses were evaluated as cure, improvement, failure, relapse or nonevaluable. Compliance and patient/parent acceptability were also analyzed.. Overall favorable clinical responses (cure plus improvement) were comparable post-therapy for the two treatments (CFX = 76%; A/C = 77%). Significant differences in response rates for both treatments were noted among different geographic regions, with the highest response rates observed in the Northeast and South. Acceptability of CFX was significantly better than that of A/C (P = 0.0001), and the adverse experience rate was lower (P = 0.001). The most frequently reported adverse experiences were diarrhea (CFX 15.2%, A/C 29.7%) and vomiting (CFX 3.2%, A/C 10.32%). Relapse rates were 26% for CFX and 29% for A/C.. This study demonstrated that CFX has comparable clinical efficacy and a better adverse events profile than A/C when used to treat AOM of childhood.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefixime; Cefotaxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Treatment Outcome

To compare the safety and efficacy, in treating acute otitis media (AOM) in children, of a new formulation of amoxicillin/clavulanate potassium (Augmentin) oral suspension providing 45/6.4 mg/kg/day and administered twice daily (bid) for 5 and 10 days, respectively, with the safety and efficacy of the original formulation providing 40/10 mg/kg/day and administered three times daily (tid) for 10 days.. Eight hundred sixty-eight children ages 2 months to 12 years with AOM were randomly assigned to one of the three treatment groups. Stringent criteria were used for the diagnosis of AOM and for determinations of "cure" and "improvement." Subjects were reexamined on Days 12 to 14 and 32 to 38.. Among subjects whose treatment and follow-up conformed fully to protocol, the proportion of treatment successes (clinically cured or improved) on Days 12 to 14 was 78.8% (149 of 189) in the tid 10-day group, 86.5% (154 of 178) in the bid 10-day group and 71.1% (140 of 197) in the bid 5-day group. Corresponding values on Days 32 to 38 were 64.2% (95 of 148) in the tid 10-day group, 63.1% (94 of 149) in the bid 10-day group and 57.8% (93 of 161) in the bid 5-day group. None of the differences between the tid 10-day regimen and either of the 2 bid regimens were statistically significant, but the bid 10-day regimen was significantly more effective than the bid 5-day regimen in younger subjects. In the study population as a whole, results were similar to those in per protocol subjects. Overall the incidence of protocol-defined diarrhea was 26.7% (74 of 277) in the tid 10-day group, compared with 9.6% (27 of 280) in the bid 10-day group (P < 0.0001) and 8.7% (25 of 286) in the bid 5-day group (P < 0.0001).. In comparison with the original formulation of Augmentin administered tid for 10 days in the treatment of AOM in children, the new formulation administered bid for 10 days provides at least equivalent efficacy and causes substantially less diarrhea. Administration for 5 days appears not to provide equivalent efficacy, but the difference appears limited to younger children and the margin of difference is small.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chemistry, Pharmaceutical; Child; Child, Preschool; Clavulanic Acids; Diarrhea; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Incidence; Infant; Logistic Models; Male; Otitis Media; Treatment Outcome

Acute otitis media is the leading reason for antibiotic prescriptions in childhood. The increase in antibiotic resistance of Streptococcus pneumoniae is generally attributed to the extensive use of antibiotics and the selective pressure on the bacterial strains of the nasopharyngeal flora.. To evaluate the change in nasopharyngeal carriage of S. pneumoniae during antibiotic therapy prescribed for acute otitis media.. Between October, 1993, and March, 1994, we conducted a clinical trial comparing cefpodoxime-proxetil and amoxicillin-clavulanate in acute otitis media. From 364 children, 4 months to 4.5 years old, a nasopharyngeal sample was obtained before and after treatment. Antibiotic susceptibility was established by determining minimal inhibitory concentrations by the agar dilution method. Serotype and randomly amplified polymorphic DNA analysis were used to compare pre- and posttreatment S. pneumoniae strains.. The risk for a child to carry penicillin-resistant S. pneumoniae (MIC > or = 0.125 mg/l) did not increase after antibiotic treatment: 84 of 364 (23.1%) before, 70 of 364 (19.2%) after. There was a significant decrease of penicillin-susceptible S. pneumoniae carriage, 117 of 364 (32.1%) before treatment compared with 24 of 364 (6.6%) (P = 0.0001) after treatment. However, among the children carrying S. pneumoniae at the end of the treatment there was an increase in the percentage of penicillin-resistant pneumococci: 84 of 201 (41.8%) before treatment and 70 of 94 (74.5%) after treatment. Among the 94 children carrying S. pneumoniae at the end of the treatment, 22 did not harbor pneumococcus before, 16 carried another genotypically different serotype and 56 harbored the same serotype. Among these 56 children 2 patients harbored strains that had increased MICs for the tested beta-lactam antibiotics. The randomly amplified polymorphic DNA analysis showed that in one case, the strains were genetically different.. These data illustrate that antibiotic therapy did not increase the rate at which children carried penicillin-resistant S. pneumoniae, but there was an increase in the rate of resistance among the children carrying pneumococci at the end of the treatment, mainly as a result of reduction of susceptible strains.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Child, Preschool; Clavulanic Acids; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Penicillin Resistance; Prospective Studies; Streptococcus pneumoniae

Two hundred and fifteen children aged 4 months 6 years with acute otitis media (AOM) were randomized to be treated either by a single i.m. injection of ceftriaxone, 50 mg/kg, with a second dose in the event of unsatisfactory response after 48 h or a history of recurrent AOM (109 patients) or amoxicillin clavulanate 12.5 mg tid (106 patients). The failure rate was similar in children treated by ceftriaxone and amoxicillin clavulanate, 4.6% and 4.7%, respectively (standard error for intergroup difference -2.87%, 95% confidence interval -5.62% to 5.87%). No significant differences between the groups were found in the dynamics of the resolution of the acute symptomatology, otoscopy findings, relapse rate at 30 days or tympanographic evidence of middle ear effusion at the scheduled visits on days 30, 60 and 90. Recurrence of AOM between days 31 and 90 was observed significantly in more children treated with amoxicillin clavulanate than with ceftriaxone--25 out of 84 (29.4%) versus 11 out of 81 (13.6%) (P = 0.012).. Ceftriaxone injection(s) is as efficient at least as 10-day oral amoxicillin clavulanate for treatment of acute otitis media in children. Although not recommended as routine, ceftriaxone can be considered in the management of acute otitis media under special circumstances, particularly in cases when the ability to tolerate or absorb oral drugs is compromised, in children refusing or unable to take oral therapy or when the compliance is questionable.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Injections, Intramuscular; Male; Otitis Media; Statistics, Nonparametric

One hundred and sixty-five consecutive patients ( > 2 years of age) with acute group A streptococcal (GAS) pharyngitis randomly received co-amoxyclav (79 patients) or phenoxymethyl penicillin (86 patients). beta-Lactamase activity in saliva was determined for each patient. At follow up after seven days, tonsillar cultures from seven patients (9.6%) in the penicillin V group grew group A streptococcus; three of these patients had tonsillitis clinically. In the co-amoxiclav group these figures were three (3.8%) and two respectively (P > 0.05). Within the 12 month follow up period, there were four clinical recurrences (6.1%) in the penicillin V group and seven (9.3%) in the co-amoxiclav group (P > 0.1). beta-Lactamase activity in the saliva was demonstrated in 29 patients (19.2%). Fourteen (74%) of 19 bacteriological failures or clinical recurrences had beta-lactamase activity, versus 15 (12%) of 129 successfully treated patients (P < 0.001). There is no evidence that oral co-amoxiclav is better than oral penicillin V for the first treatment of acute GAS pharyngitis, but bacteriological failure and clinical recurrence are strongly associated with the presence of beta-lactamase activity in commensal flora.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamases; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Penicillin V; Penicillins; Pharyngitis; Saliva; Streptococcal Infections

In a double-blind, placebo-controlled trial, patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) were randomly allocated to oral treatment with sparfloxacin (200 mg loading dose followed by 100 mg once daily) or amoxycillin/clavulanic acid (500 mg/125 mg tds) for a total treatment duration of 7 to 14 days. Patients were evaluable if they had a FEV1/FVC ratio of less than 70% at stable state and presented with a suspected infectious exacerbation defined as increases in dyspnoea, sputum volume and sputum purulence. The primary efficacy variable was the overall success (defined as disappearance or improvement of dyspnoea and reductions in sputum volume and purulence) at end of treatment and follow-up. Overall efficacy was assessed in both the intent-to-treat (728 patients) and the evaluable (351 patients) populations. At the end of treatment and follow-up, success rates were identical for the sparfloxacin (87.3% and 78.7%) and amoxycillin-clavulanic acid (88.8% and 79.8%) treatment groups. Similar figures were found for the intent-to-treat population. The analysis of drug safety was similar for both treatment groups. The most frequently encountered pathogens were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Sparfloxacin appeared superior for bacteriological eradication of Haemophilus influenzae, and Moraxella catarrhalis. Sparfloxacin in a single daily dose appears at least as effective as amoxycillin/clavulanic acid in the treatment of patients with acute exacerbations of COPD.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Fluoroquinolones; Haemophilus influenzae; Humans; Lung Diseases, Obstructive; Middle Aged; Moraxella catarrhalis; Quinolones; Streptococcus pneumoniae

In recent years there has been considerable interest in reducing the duration of antibiotic treatment regimens in patients with common bacterial infections. We conducted two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle ear fluid obtained by tympanocentesis, comparing the efficacy and safety of 5 or 10 days of treatment with cefuroxime axetil suspension (CAE) with that of 10 days of treatment with amoxicillin/clavulanate suspension (AMX/CL) in children with acute otitis media.. A total of 719 pediatric patients from the ages of 3 months to 12 years were enrolled in the 2 studies. Patients received CAE for either 5 or 10 days at 30 mg/kg/day in 2 divided doses (n = 242 and 235, respectively) or AMX/CL for 10 days at 40 mg/kg/day in 3 divided doses (n = 242). Patients in the CAE (5 days) group received placebo on Days 6 through 10. In the study that included tympanocentesis, bacteriologic assessments were based on middle ear fluid cultures obtained pretreatment and, when possible, after treatment in patients with an unsatisfactory clinical outcome.. Organisms were isolated from the pretreatment middle ear fluid specimens of 177 of 244 (73%) patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis (37, 35 and 12% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 92% (24 of 26), 84% (32 of 38) and 95% (36 of 38) of bacteriologically evaluable patients treated with CAE for 5 or 10 days or with AMX/CL, respectively. A satisfactory clinical outcome (cure or improvement) occurred in 69% (101 of 147), 70% (121 of 173) and 74% (131 of 177) of clinically evaluable patients treated with CAE (5 days), CAE (10 days) or AMX/CL, respectively. Treatment with AMX/CL was associated with a significantly higher incidence of drug-related adverse events than was treatment with CAE for either 5 or 10 days (P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs. 17 and 12%, respectively; P < 0.001), particularly diarrhea.. Treatment with CAE given twice daily for 5 days is equivalent to treatment for 10 days either with the same regimen of CAE or with AMX/CL given three times daily in pediatric patients with acute otitis media.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefuroxime; Child; Child, Preschool; Clavulanic Acids; Confidence Intervals; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Prodrugs; Prospective Studies; Suspensions; Treatment Outcome

This randomized, open label study compared the efficacy and safety of a 5-day course of once daily azithromycin to those of a 10-day course of three times daily amoxicillin/ clavulanate.. One hundred sixty-nine children with confirmed acute bacterial otitis media were randomized to treatment with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days or 40 mg/kg/ day of amoxicillin/clavulanate suspension in three divided doses for 10 days. Clinical efficacy and safety were evaluated on Days 11 and 30.. Analysis of evaluable patients 11 days after the start of treatment demonstrated that 87.8% of patients treated with azithromycin and 100.0% of the patients treated with amoxicillin/ clavulanate were cured or improved. Presumed bacteriologic eradication of the baseline pathogens Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes was comparable in the two groups: 87.8% in patients treated with azithromycin; and 100.0% in patients receiving amoxicillin/clavulanate. At Day 30, 82.2% of patients treated with azithromycin and 80.0% of patients treated with amoxicillin/clavulanate were cured or improved. Presumed bacteriologic eradication of the base-line pathogens was similar in the two groups: 82.2% in patients treated with azithromycin; and 81.1% in patients receiving amoxicillin/clavulanate. Relapses occurred in 5.1% of patients receiving azithromycin and 21.1% of patients taking amoxicillin/clavulanate (P = 0.047). Treatment-related side effects occurred in 3.5% of the azithromycin patients compared with 31.0% of amoxicillin/clavulanate patients (P < 0.001).. Azithromycin was comparable to amoxicillin/clavulanate in achieving clinical cure or improvement and presumed eradication of baseline pathogens in pediatric patients with acute otitis media. Azithromycin was significantly better tolerated and was associated with fewer relapses than seen after amoxicillin/clavulanate therapy.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Otitis Media

To compare the efficacy and safety of azithromycin and amoxicillin/clavulanate in pediatric acute otitis media.. Investigators from 12 US centers recruited 677 children. In a randomized, double blind, double dummy fashion, participants received either azithromycin suspension (n = 341) once daily for 5 days or amoxicillin/clavulanate suspension (n = 336) in three divided doses daily for 10 days.. Among evaluable patients satisfactory clinical response rates (cured and improved) measured 11 days after therapy began were 87.5% in the azithromycin group and 87.9% in the amoxicillin/clavulanate group; corresponding rates at 30 days were 73.5% in the azithromycin and 71.2% in the amoxicillin/clavulanate groups. Relapse rates were comparable for the treatment groups. Treatment-related side effects, primarily gastrointestinal, were reported significantly less frequently with azithromycin (8.8%) than with amoxicillin/clavulanate (30.8%) (P < 0.0001). Two (0.6%) azithromycin patients and 12 (3.6%) amoxicillin/ clavulanate patients discontinued therapy because of treatment-related side effects (P < 0.006 between groups).. In these children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Humans; Infant; Otitis Media

This multicenter, randomized, open label study compared the efficacy and safety of azithromycin and amoxicillin/clavulanate for the treatment of acute otitis media among children who were attending a day-care facility or school.. Eligible children with acute otitis media from 21 US centers were randomized to treatment with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days or approximately 40 mg/kg/day of amoxicillin/clavulanate suspension in 3 divided doses for 10 days. Clinical efficacy was evaluated on Days 14, 30 and 45. Acceptance and convenience of the medications were assessed on Day 14 by parent interviews with a standardized questionnaire.. Of the 263 children enrolled in the study, 233 were evaluable at the primary evaluation 45 days after the start of treatment. Satisfactory clinical response rates (cure, delayed cure and improvement) were 60.5% in patients treated with azithromycin and 64.9% in patients treated with amoxicillin/clavulanate. Satisfactory clinical response rates at secondary evaluations were also comparable: 92.2% vs. 90.0% at Day 14 and 66.7% vs. 72.7% at Day 30 in patients treated with azithromycin and amoxicillin/clavulanate, respectively. No significant differences in treatment failures, relapses or recurrences were noted with either medication. Azithromycin was significantly better tolerated and caused fewer treatment-related adverse events (7.2%) than amoxicillin/clavulanate (17.1%) (P < 0.001). In response to the interview and questionnaire, parents of children treated with azithromycin noted less need for special arrangements to give medication (2.0% vs. 14.9%). Children liked the taste of azithromycin (89.2%) and did not have to be forced to take the medication (2.4%). Parents of children receiving amoxicillin/clavulanate noted that 61.8% liked the medication and 19.4% of children had to be forced to take it.. This study demonstrates that azithromycin was comparable to amoxicillin/clavulanate in achieving satisfactory clinical response rates in children with acute otitis media attending day care or school. Azithromycin was significantly better tolerated than amoxicillin/ clavulanate. Parents considered azithromycin to be significantly more convenient to administer and more acceptable to children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child Day Care Centers; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Schools

The efficacy and safety of ceftibuten (9 mg/kg daily for 10 days) were compared with those of amoxicillin/clavulanate (Augmentin 40 mg/kg/day given every 8 hours for 10 days) in the empiric treatment of acute otitis media in children. This was a multicenter, investigator-blinded study with 1:1 randomization. Overall clinical response and signs and symptoms of otitis were collected prospectively pretreatment, 3 to 5 days during treatment, 1 to 3 days post-treatment and at 2- to 4-week follow-up. In addition to spontaneous reports of other adverse events, gastrointestinal adverse events were prospectively elicited at each visit. Two hundred ninety-six patients (146 ceftibuten and 150 amoxicillin/clavulanate) were treated with at least 1 dose of study medication. Compliance with dosing was assessable with weight of drug consumed in 127 patients in each treatment group. Five percent (6 of 127) of ceftibuten patients and 11% (14 of 127) of amoxicillin/clavulanate patients received < 80% of prescribed drug (P = 0.10) and were therefore not valid. Two hundred twenty-two patients (121 ceftibuten and 101 amoxicillin/clavulanate) received a minimum of 80% of prescribed medication and were compliant with the protocol. Ceftibuten and amoxicillin/clavulanate groups were comparable both for demographic variables and for baseline signs and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftibuten; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Patient Compliance; Treatment Outcome

Although it varies from country to country, there is a worrying worldwide increase in antibiotic resistance among pathogens causing otitis. This has led to a search for therapeutic alternatives to the reference treatment, which is still amoxicillin in many countries. Cefpodoxime proxetil is one such alternative. Six comparative randomized trials of cefpodoxime proxetil in childhood acute otitis media have been published or presented at international conferences. They involved a total of 1188 patients, 658 of whom received cefpodoxime proxetil and 530 of whom received the comparator drug (amoxicillin/clavulanic acid in 3 trials, cefaclor in 1, and cefixime in 2); duration of treatment varied from 5 days for cefpodoxime proxetil to 10 days for amoxicillin/clavulanic acid, and the age of the children included ranged from 2 months to 12 years. The clinical efficacy of cefpodoxime proxetil was at least equivalent to that of the comparators in 4 trials and significantly better in 2 trials. Firstly, in one study vs. amoxicillin/clavulanic acid, the superiority of cefpodoxime proxetil (8 mg/kg/day twice daily) in terms of healing at the end of treatment and in terms of the number of normal tympanograms at the follow-up visit was shown. Secondly, in a study performed by our group, vs. cefixime, cefpodoxime proxetil (8 mg/kg/day twice daily) showed a better healing rate at the end of treatment in febrile and painful acute otitis media. The microbiologic and pharmacokinetic data show that cefpodoxime proxetil is one of the most active compounds against Haemophilus influenzae and Streptococcus pneumoniae.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Otitis Media; Prodrugs; Randomized Controlled Trials as Topic; Streptococcus pneumoniae; Treatment Outcome

We performed a randomized, double-blind, placebo-controlled study to determine whether acute otitis media could be prevented by antibiotic therapy initiated promptly after the appearance of symptoms of upper respiratory tract infection. One hundred four children aged 1 to 4 years received a 7-day course of either amoxicillin-clavulanate or placebo. Acute otitis media developed in 9 (18%) of the 50 children receiving amoxicillin clavulanate and in 12 (22%) of the 54 children receiving placebo (p = 0.59).

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chi-Square Distribution; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Respiratory Tract Infections; Statistics, Nonparametric; Time Factors

We conducted a large, multicenter, randomized, open-label study throughout France comparing the efficacy and safety of cefixime suspension (8 mg/kg/day, b.i.d., for 10 days) versus amoxicillin-clavulanate suspension (80 mg/kg/day, t.i.d., for 10 days) in 510 children (ages 6 to 36 months) with acute otitis media. The most frequent microorganisms colonizing the nasopharynx at the start of treatment were Streptococcus pneumoniae (51.5%), Haemophilus influenzae (45%) and Moraxella catarrhalis (30.2%). Rates of beta-lactamase positivity were 32.1% and 95.3% for H. influenzae and M. catarrhalis, respectively. Decreased susceptibility of S. pneumoniae to penicillin was found in 39.7% of isolates. Clinical efficacy was 87.8% (223/254) for cefixime and 87.0% (215/247) for amoxicillin-clavulanate. At the 5-week follow-up visit, relapse had occurred in 15.7% (31/197) of cefixime-treated patients and in 15.6% (32/205) of those treated with amoxicillin-clavulanate. We conclude that these two regimens are equally effective in acute otitis media in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Cefixime; Cefotaxime; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Nasopharynx; Otitis Media

Five hundred thirty-seven patients were enrolled in two independent, investigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10-day treatment with cefuroxime axetil with those of 10-day treatment with amoxicillin-clavulanate in the treatment of secondary bacterial infections of acute bronchitis. Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twice daily or 10 days of treatment (n = 183) with amoxicillin-clavulanate at 500 mg three times daily. Patients in the cefuroxime axetil (5 days) group received placebo on days 6 to 10. Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when possible, following treatment. Organisms were isolated from the pretreatment sputum specimens of 242 of 537 (45%) patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus (28, 25, 13, 9, and 8% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. A satisfactory clinical outcome (cure or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37 versus 19 and 15%, respectively; P < 0.001), particularly diarrhea and nausea. These results indicate that treatment with cefuroxime axetil at 250 mg twice daily for 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis. In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with significantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxic

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bronchitis; Cefuroxime; Cephalosporins; Child; Clavulanic Acids; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Treatment Outcome

In this open comparative and prospective study 180 adults of either sex were randomised to treatment with either amoxicillin/clavulanic acid (AMC) 500/125mg tid or cefetamet pivoxil (CAT) 500mg bid for 7 days. Demographic data and assessable findings were similar in both groups. Clinical outcomes of 169 assessable patients showed high efficacy of both drugs: 92% with AMC and 96% with CAT. Bacteriological response rates were equivalent in 141 evaluable cases: 84% vs. 89%, respectively. Baseline susceptibility testing (DIN) revealed a notable number of Haemophilus species either intermediately susceptible or resistant to AMC. Gastrointestinal disorders predominated among the adverse events with diarrhea occurring nearly twice as often in the AMC group. CAT is an effective and safe alternative option in the treatment of AECB in adults. The advantage of CAT is its enhanced activity against gram-negative bacteria. It is well tolerated.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Ceftizoxime; Cephalosporins; Chronic Disease; Clavulanic Acids; Drug Therapy, Combination; Female; Gastrointestinal Diseases; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Prospective Studies

A total of 260 children, 3 months to 11 years old (median age 24 months), with acute otitis media (AOM) received either cefpodoxime proxetil (CP) 8 mg/kg/d b.i.d. or amoxicillin/clavulanic acid (ACA) 40/10 mg/kg/d t.i.d. for 8 days. A significant difference in clinical cure rates was observed between the CP group 71/118 (60%) and the ACA group 42/105 (40%), p = 0.003. At the follow-up visit (20-30 days after the start of treatment), significant advantages were recorded with the CP vs. ACA therapy, in terms of satisfactory clinical response [90/111 (81%) vs 60/94 (63.8%), p = 0.005] residual middle ear effusion (14.4% vs 28.7%, p = 0.01) and normal tympanometry (78% vs 61.4%, p = 0.017). Compliance and adverse event frequency were the same in both treatment groups. The higher clinical cure rate and equivalent safety profile of CP indicates that it is an acceptable alternative to ACA for the treatment of AOM in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefpodoxime Proxetil; Ceftizoxime; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Patient Compliance; Prodrugs; Treatment Outcome

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

Cefprozil is a new oral cephalosporin with activity against the most common pathogens isolated in acute otitis media. This randomized study enrolled 361 patients (mean age 29 months). Physical examination and culture via tympanocentesis were required less than 48 h before therapy. One hundred and ninety-one patients were evaluable for clinical efficacy; 99 received cefprozil (20 mg/kg/day bd) and 92 received amoxycillin/clavulanate (13.3 mg/kg/day tid). Duration of treatment was 7-9 days for 81 patients, 10 days for 105 patients and 11-16 days for five patients. The treatment groups were comparable with respect to demographics, severity of infection and number of previous episodes. Clinical evaluations of efficacy were based on physical examination including otoscopy within a 14 day period after therapy. Satisfactory clinical responses were achieved in 84% of cefprozil-treated patients and 87% of amoxycillin/clavulanate-treated patients. Pathogens most commonly isolated included Haemophilus influenzae (33%) and Streptococcus pneumoniae (22%). All 361 patients were evaluable for safety. Adverse clinical events were reported in 13% (24) of cefprozil-treated patients and 20% (36) of amoxycillin/clavulanate-treated patients. Cefprozil, administered twice a day, is comparable to a regimen of amoxycillin/clavulanate three times a day in the treatment of acute otitis media in children.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefprozil; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Neisseriaceae Infections; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

The presence of otitis media with effusion (OME) and high negative pressure (-200 to -400 mm H2O), were investigated in the follow-up of a randomized double-blind placebo-controlled trial on the efficacy of amoxicillin/clavulanic acid in the treatment of acute otitis media. All children in this study were recruited from a general practice population. Tympanometry results 1 month from the start of an episode of acute otitis media were taken as outcome criteria. Bilateral middle ear dysfunction was defined as bilateral OME, unilateral OME and contralateral or bilateral high negative pressure. Bilateral middle ear dysfunction was present in 47.9% of the patients. Of all the investigated factors of possible influence (age, sex, season, laterality of acute otitis media, therapy, and clinical course of acute otitis media), only season showed a statistically significant influence on the persistence of OME/high negative pressure (P = 0.001). Bilateral middle ear dysfunction was shown to be of prognostic value for the risk of a recurrence of acute otitis media (odds ratio 3.75).

Topics: Acoustic Impedance Tests; Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Ear, Middle; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Placebos; Recurrence; Risk Factors

A new macrolide drug, clarithromycin (Biaxin) was compared with amoxicillin/clavulanate (Augmentin) in a single-blind (investigator-blind), randomized, multicenter study of 497 outpatients with acute maxillary sinusitis; treatment was 500 mg clarithromycin bid (n = 246) or 500 mg amoxicillin/clavulanate tid (n = 251). Pathogens included Streptococcus pneumoniae in 22% of patients, Staphylococcus aureus in 16%, Haemophilus influenzae in 10%, and Moraxella catarrhalis in 7%. For evaluable patients, clinical success (cure or improvement) was noted for 97% (128/132) of clarithromycin recipients and 93% (119/128) amoxicillin/clavulanate recipients. Clinically significant improvement in signs and symptoms was comparable between groups. Bacteriologic cure rates were 87% (115/132) and 90% (115/128), respectively. Respective pathogen eradication rates were 87% (125/143) and 90% (125/139). Adverse events not due to concurrent conditions occurred in 41% of the former and 46% of the latter group; most were mild to moderate gastrointestinal upsets (21% and 38%, respectively; P < 0.001). We conclude that clarithromycin appears to be as effective as amoxicillin/clavulanate in acute maxillary sinusitis and may cause fewer gastrointestinal upsets.

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Bacterial Infections; Clarithromycin; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Maxillary Sinusitis; Single-Blind Method; Treatment Outcome

A total of 311 children who had recurrent otitis media or who had experienced failure of initial treatment of acute otitis media with phenoxymethylpenicillin, amoxicillin, ampicillin esters or cefaclor were entered into a single-blind study in two parallel groups in order to compare the clinical efficacy and safety of amoxicillin/clavulanate suspension given b.i.d. or t.i.d. for seven days. The patients were examined prior to the start of treatment, at an early follow-up visit 9 to 12 days after the start of treatment and at a late follow-up visit about three weeks later. Specimens for bacteriological culture were taken from the nasopharynx at entry, at the early follow-up visit, and at the late follow-up visit if there were symptoms of otitis. Both treatment groups showed a similar response, 90% or more of the patients being cured or showing improvement at the time of the early follow-up visit. The initial nasopharyngeal cultures showed growth of Haemophilus influenzae in 53% of the patients, Moraxella catarrhalis in 43% and Streptococcus pneumoniae in 39%. After treatment, cultures showed elimination of the initial pathogens in 30% of patients in both groups and recolonization in 23% in both groups. Haemophilus influenzae was the bacteria most frequently found in the nasopharynx at the first follow-up visit. Adverse effects, which consisted mostly of gastrointestinal and dermatological reactions, tended to be more common in the b.i.d. group but the difference was not statistically significant.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chi-Square Distribution; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Nasopharynx; Otitis Media; Patient Compliance; Recurrence; Single-Blind Method; Streptococcus pneumoniae

An open randomized trial was conducted in 159 children (aged 1 to 8 years) with acute otitis media to compare the clinical efficacy of azithromycin (n = 105) and co-amoxiclav (n = 54). Azithromycin (10 mg/kg/day) was administered as a single dose for three days and co-amoxiclav was given tid for ten days at a dosage according to the manufacturer's instructions for the country. Of 103 evaluable azithromycin patients on day 3 to 5 after the start of therapy, 31 (30%) were considered cured, 67 (65%) improved and five (5%) failed compared with eight (15%) cured, 45 (83%) improved and one (2%) failed among the 54 evaluable co-amoxiclav treated patients. There was a higher number of azithromycin patients with complete resolution of symptoms at this first visit (P = 0.056). By day 10 to 12, clinical equivalence between the two treatment groups was observed with clinical cure in 86 (88%), improvement in 11 (11%) and failure in one (1%) of the 98 azithromycin patients, and in the 54 patients treated with co-amoxiclav, clinical cure was observed in 45 (83%), and improvement in nine (17%) patients. Both drugs were well tolerated and treatment related side-effects were reported in 8/105 (8%) azithromycin and 2/54 (4%) co-amoxiclav patients. In the azithromycin treatment group, these were predominantly mild to moderate gastrointestinal effects, whilst in the co-amoxiclav treatment group, both reports were of mild erythematous rash. One patient from each treatment group was withdrawn due to side-effects (azithromycin--diarrhoea and vomiting; co-amoxiclav--erythematous pruritic rash).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Erythromycin; Female; Humans; Infant; Male; Otitis Media

A total of 389 children (age 0.6-10.2 years) with typical signs and symptoms of acute otitis media were randomized (1:1) to treatment with either azithromycin or co-amoxiclav. The dosage schedule for azithromycin was 10 mg/kg/day, in a single daily dose, administered for three days. Co-amoxiclav was given at a dose of 13.3 mg/kg (amoxycillin equivalent) tid for ten days. Patients were evaluated 4-6 days and 12-16 days after the start of therapy. A satisfactory clinical response was reported for 93.2% of the 192 evaluable azithromycin-treated patients (144 cured, 35 improved), and for 97.3% of the 189 evaluable co-amoxiclav-treated patients (148 cured, 36 improved). Six (3.0%) relapses occurred in the azithromycin group, and four (2.1%) in the co-amoxiclav treatment group, respectively. Side-effects were recorded in a significantly fewer number of the azithromycin patients (23 of 197; 11.7%) compared with the co-amoxiclav patients (43 of 192; 22.4%, P < 0.02). Adverse events were mainly gastrointestinal in nature, with diarrhoea the most frequent complaint (32 cases with co-amoxiclav; five with azithromycin; P < 0.001). One patient from each group discontinued therapy because of treatment-related adverse events. Laboratory analyses (mainly haematological in nature) showed abnormalities in six of 100 azithromycin patients and ten of 101 co-amoxiclav patients. It was concluded that three-day, single-dose azithromycin and ten-day tid co-amoxiclav therapy have comparable clinical efficacy in paediatric patients with acute otitis media; however, there was a lower incidence of side effects in the azithromycin group.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Combinations; Erythromycin; Female; Humans; Infant; Male; Otitis Media

The efficacy and safety of a once-daily oral regimen of 400 mg ceftibuten was compared with oral co-amoxiclav 500 mg three times daily in a multicentre, single-blind study. In patients with a bacteriologically confirmed infection, a successful clinical outcome was reported in 25 of 25 patients treated with ceftibuten and 10 of 10 patients treated with co-amoxiclav. In a further group of 88 patients, most of whom had been excluded from the primary efficacy evaluation because no pathogen was isolated pretreatment, overall successful clinical outcomes of 87% and 88% were reported for ceftibuten and co-amoxiclav, respectively. The duration of treatment and the time to resolution of the signs and symptoms of sinusitis were not significantly different in the two treatment groups. The incidence of adverse events was higher in the co-amoxiclav-treated patients (31% versus 15% in the ceftibuten group) as was the incidence of severe events (10% for co-amoxiclav-treated patients versus < 1% in the ceftibuten group). In summary, once-daily ceftibuten can be considered a safe and effective treatment for acute bacterial sinusitis.

Topics: Acute Disease; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Ceftibuten; Cephalosporins; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Single-Blind Method; Sinusitis

This multicenter study compared the clinical and bacteriologic efficacy of two oral antibiotics, cefuroxime axetil and amoxicillin/clavulanate, in the treatment of acute bacterial maxillary sinusitis.. Three hundred seventeen patients with clinical and radiographic evidence of acute maxillary sinusitis were enrolled at nine centers and were randomly assigned to receive 10 days of treatment with cefuroxime axetil 250 mg twice daily (n = 157) or amoxicillin/clavulanate 500 mg three times daily (n = 160). Patients were assessed for both clinical and bacteriologic responses once during treatment (5 to 7 days) and twice after treatment (1 to 3 days and 4 weeks). Bacteriologic assessments were based on needle aspirates of the maxillary sinus obtained pretreatment and, when possible, at the first posttreatment visit.. Organisms were isolated from the pretreatment sinus aspirates of 198 of 317 (62%) patients, with the primary isolates being Streptococcus pneumoniae (22%), Haemophilus spp. (17%), Staphylococcus aureus (13%), and Haemophilus influenzae (10%). A satisfactory clinical outcome (cure or improvement) was achieved in 85% (98 of 115) and 82% (102 of 124) of the clinically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.446). With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 84% (31 of 37) and 87% (34 of 39) of bacteriologically evaluable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (p = 0.567). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events (13% versus 3%, p = 0.001), particularly diarrhea (8% versus 1%, p = 0.001). Two patients in the cefuroxime axetil group and three patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events.. Our results indicate that cefuroxime axetil twice a day is as effective as amoxicillin/clavulanate three times a day in the treatment of acute bacterial maxillary sinusitis but produces fewer adverse effects.

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefuroxime; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Humans; Maxillary Sinusitis; Prodrugs; Single-Blind Method; Treatment Outcome

Cefetamet pivoxil was investigated in an open, randomized comparative study involving a total of 37 children with acute pyelonephritis, whose ages ranged from 2 to 14 years. The patients received either 10 mg/kg (n = 18) or 20 mg/kg (n = 8) cefetamet pivoxil twice daily, or 30-50 mg/kg amoxycillin/clavulanic acid three times daily (n = 11) for a period of 7-10 days. Escherichia coli was the main causative agent isolated in 28 (75.7%) of the patients; other pathogens included Proteus mirabilis (three patients). Proteus species (one patient), Klebsiella pneumoniae (two patients), Pseudomonas diminuta (one patient) and mixed infections (three patients). No differences in the overall treatment outcome could be observed between the treatment regimens used and, at the end of treatment, all pathogens were eradicated with neither relapse, nor persistence of the isolated pathogen, nor reinfection occurring. The clinical signs and symptoms had subsided in all patients at treatment end and the tolerability of the trial drugs was found to be satisfactory with no premature treatment withdrawal required. It is concluded that cefetamet pivoxil in the standard twice-daily dose of 10 mg/kg was equally effective and as well tolerated as 20 mg/kg cefetamet pivoxil given twice daily or 30-50 mg/kg amoxycillin/clavulanic acid given three times daily.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftizoxime; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Drug Tolerance; Escherichia coli Infections; Female; Humans; Male; Proteus Infections; Pyelonephritis

In two randomized clinical trials in children with otitis media, the efficacy and safety of cefprozil are compared to those of amoxicillin/clavulanate (n = 530) and of cefaclor and cefixime (n = 394). The rate of clinical cure or improvement was similar among patients receiving each drug regimen, ranging from 78% for amoxicillin/clavulanate to 89% for cefaclor; for cefprozil, this rate was 84% and 85% in the two studies, respectively. In the first study, cefprozil was superior to amoxicillin/clavulanate in the satisfactory clinical response rate for Streptococcus pneumoniae (P = .049), but response rates were similar for Haemophilus influenzae and Moraxella catarrhalis. Significantly more patients treated with amoxicillin/clavulanate (P less than .001) in the first study or cefixime (P less than .01) in the second study developed diarrhea than did those treated with cefprozil. We conclude that cefprozil therapy for otitis media in children produces clinical and bacteriologic response rates similar to those seen with amoxicillin/clavulanate, cefixime, or cefaclor. Furthermore, diarrhea was significantly less common with cefprozil than with cefixime or amoxicillin/clavulanate.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion

A regimen of cefprozil (500 mg twice daily), a new oral cephalosporin with a broad in vitro spectrum of antimicrobial activity, was compared to standard regimens of cefaclor (500 mg three times daily), cefuroxime axetil (500 mg twice daily), or amoxicillin/clavulanate (500 mg/125 mg three times daily) for the treatment of lower respiratory tract infections (mainly bronchitis and acute exacerbations of chronic bronchitis) in adults in three open-label, randomized trials. In the first trial, in which bacterial pathogens were isolated in initial cultures for only one-third of the patients, 90% of the pathogens were susceptible to cefprozil. A satisfactory clinical response was noted for 84% of the evaluable patients who received cefprozil versus 79% of those who received cefaclor for treatment of lower respiratory tract infections; rates of bacteriologic efficacy were 82% and 78%, respectively. In the second study rates of satisfactory clinical response were 96% with cefprozil and 83% with cefuroxime axetil (P less than .03) for treatment of bronchitis; the respective bacteriologic response rates were 100% and 92%. In the third trial, clinical efficacy was 91% for cefprozil and 87% for amoxicillin/clavulanate for treatment of bronchitis; bacteriologic efficacy was 95% and 96%, respectively. Tolerability and safety profiles were comparable, except that there was a higher rate of diarrhea among patients who received amoxicillin/clavulanate (P = .03).

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Bronchopneumonia; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Humans; Pneumonia, Pneumococcal

Two controlled clinical trials compared loracarbef (LY163892 with amoxicillin/clavulanate or amoxicillin in the treatment of acute exacerbations of chronic bronchitis. Collectively, of 1,057 patients enrolled, 390 qualified for analysis: group 1 comprised 200 patients treated with loracarbef (400 mg twice daily); group 2, 120 patients treated with amoxicillin/clavulanate (500 mg three times daily); and group 3, 70 patients treated with amoxicillin (500 mg three times daily). Symptomatic and bacteriologic outcomes were assessed at post-therapy (within 72 hours of therapy completion), and at late-posttherapy (10-14 days after therapy completion). These evaluations were combined to provide an "overall" evaluation that accounted for all unfavorable outcomes occurring at either the posttherapy or late-posttherapy visit. At the posttherapy evaluation, 93.0% of group 1 patients, 95.0% of group 2 patients, and 88.6% of group 3 patients demonstrated favorable clinical outcomes (cure or improvement). "Overall" favorable clinical outcomes were achieved in 88.0% of group 1 patients, 90.0% of group 2 patients, and 81.4% of group 3 patients. Bacteriologic results from the two studies could not be merged due to marked differences in how posttherapy bacteriologic results were assessed. The clinical significance of positive posttherapy sputum cultures was doubtful: 90% of patients with a positive sputum culture at the posttherapy visit who returned for the late-posttherapy visit had successful clinical outcomes documented at the late-posttherapy evaluation. Loracarbef was associated with a lower incidence of diarrhea and a higher incidence of headache as compared with amoxicillin/clavulanate. These results suggest that 400 mg loracarbef twice daily for 7 days is effective and safe in the treatment of acute exacerbations of chronic bronchitis.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bronchitis; Cephalosporins; Chronic Disease; Clavulanic Acids; Diarrhea; Drug Therapy, Combination; Europe; Female; Headache; Humans; Incidence; Male; Middle Aged; Treatment Outcome; United States

Pathogenic bacteria were isolated from 90% of patients with acute otitis media. This higher-than-expected rate of positive cultures was probably related to the meticulous bacteriologic techniques used.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Bacteriological Techniques; Cefixime; Cefotaxime; Cefpodoxime Proxetil; Ceftizoxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Moraxella catarrhalis; Otitis Media; Prodrugs; Punctures; Recurrence; Single-Blind Method; Streptococcus pneumoniae; Tympanic Membrane

Forty-eight patients with acute bronchitis and four with pneumonia were randomly assigned to receive five doses (500 mg on day 1, plus 250 mg/day on days 2-5) of azithromycin; 54 patients with acute bronchitis and four with pneumonia were assigned 30 doses (625 mg every eight hours for ten days) of amoxicillin/clavulanic acid (CA). The two regimens were equally effective, with clinical improvement or cure in 92% and 87% of patients respectively, bacteriological cure in 89% and 86%, with 91% and 89% of pathogens eliminated. Minor side effects occurred in 6% and 12% of patients in the two groups, respectively. No major abnormalities in laboratory safety parameters were seen in either group.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Bronchitis; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Erythromycin; Female; Humans; Male; Middle Aged; Pneumonia; Pseudomonas aeruginosa; Streptococcus pneumoniae

To determine the efficacy of coamoxiclav in children aged 6 months to 12 years with recurrent acute otitis media.. A randomised double blind placebo controlled clinical trial.. General practice in the Netherlands.. 121 children with recurrent acute otitis media, defined by onset of otalgia and otoscopic signs of middle ear infection within four to 52 weeks after the previous attack. Confirmation of diagnosis and randomisation was done by otolaryngologists.. Oral co-amoxiclav or placebo in weight related doses for seven days.. An irregular clinical course defined as the presence of otalgia or a body temperature greater than or equal to 38 degrees C, or both, after three days.. Eleven (16%; 95% confidence interval 9% to 28%) children had an irregular course in the co-amoxiclav group and 10 (19%; 9% to 31%) in the placebo group (difference not significant). Age, dichotomised at 2 years, was the only significant prognostic factor for irregular course of the disease (odds ratio 5.9; 1.8 to 19.1). Among children aged below 2 years, 28% (4/14) in the co-amoxiclav group and 58% (7/12) in the placebo group had irregular courses. For children 2 years and older these percentages were 13% (7/52) and 7% (3/41).. Children with recurrent acute otitis media are at greater risk of an irregular clinical course of the disease than children with a first episode of acute otitis media. Co-amoxiclav has no significant benefit over placebo in treating children over 2 years with acute otitis media.

Topics: Acute Disease; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Prognosis; Recurrence

One hundred five infants and children with acute otitis media were randomized to therapy with loracarbef, an experimental carbacephem antibiotic, or amoxicillin-clavulanate (Augmentin), an approved drug for this disease. Ninety-two were evaluable (46 in each group). Middle ear fluid samples obtained for culture before therapy grew Haemophilus spp. in 30% of cases, pneumococci in 29% of cases, and Moraxella catarrhalis in 15% of cases. beta-Lactamase-producing bacteria were found in 37% of patients. Clinical failure occurred in four loracarbef-treated patients and one amoxicillin-clavulanate-treated patient (P = 0.361). Recurrence of acute otitis media was more common in the 2 to 3 weeks after loracarbef treatment (eight patients) than it was after amoxicillin-clavulanate therapy (three patients), but not significantly so (P = 0.197). Thus, combined failure and recurrence occurred in 12 loracarbef-treated patients and four amoxicillin-clavulanate-treated patients (P = 0.052). Gastrointestinal side effects occurred in 13 loracarbef-treated and 21 amoxicillin-clavulanate-treated patients (P = 0.13). Diaper rash was more common with amoxicillin-clavulanate (22 patients) than with loracarbef (10 patients; P = 0.016). Satisfactory results were achieved with both antibiotics, and adverse effects, although common, were minor.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Cephalosporins; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Random Allocation; Recurrence

A total of 102 children with recurrent otitis media or therapeutic failure after treatment with phenoxymethyl penicillin were entered into a double-blind study with parallel groups, comparing treatment with amoxycillin/clavulanate suspension (Spektramox) for 7 days with amoxycillin suspension (Imacillin) for 10 days. Bacterial and clinical investigations were performed. A total of 91 patients were evaluated for efficacy at the first follow-up visit (10-12 days after start of treatment). Amoxycillin/clavulanate and amoxycillin showed equally high, satisfactory treatment results, i.e. more than a 90% response. Similarly, there was no statistically significant difference between the treatment groups at the second follow-up visit (about 30 days after start of treatment). Bacteriological cultures from the nasopharynx showed equal distribution of Haemophilus influenzae, Branhamella catarrhalis and Streptococcus pneumoniae between the study groups. Elimination of the initially occurring pathogens was equal in the two study groups with the exception of B. catarrhalis which was eliminated to a significantly higher extent with amoxycillin/clavulanate. Both drugs were well tolerated. In patients with recurrent otitis media or therapeutic failure, treatment with amoxycillin/clavulanate for 7 days results in high, satisfactory clinical effects and is comparable to treatment with amoxycillin for 10 days.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Haemophilus Infections; Humans; Male; Moraxella catarrhalis; Otitis Media; Penicillin V; Pneumococcal Infections; Time Factors

A total of 137 children with acute otitis media with effusion were randomly allocated to treatment with cefprozil (30 mg/kg/day divided into two equal doses), an investigational cephalosporin or amoxicillin clavulanate potassium (40 mg/kg/day divided into three equal doses) for 10 days. The most common pathogens obtained from middle ear cavities by tympanocentesis were Streptococcus pneumoniae (33%), Haemophilus influenzae (19.6%) and Moraxella catarrhalis (8.3%). Patients were scheduled for follow-up visits at midtreatment, at end of therapy and at 30 days. Of the 137 children 122 were evaluable. Five of 60 patients (8.3%) treated with cefprozil and 14 of 62 patients (22.5%) treated with amoxicillin clavulanate potassium were considered therapeutic failures because of persistence of symptoms and/or isolation of the original pathogen or superinfection (P = 0.05). Rates of relapse, reinfection and persistent middle ear effusion as documented by tympanogram were comparable in both groups. When persistent middle ear effusion was analyzed by pneumatic otoscopy, 64 of 103 affected ears (62.1%) treated with cefprozil and 80 of 105 affected ears (76.1%) treated with amoxicillin clavulanate potassium were abnormal (P = 0.04). Loose stools were more common in children treated with amoxicillin clavulanate potassium than in children treated with cefprozil (P = 0.0004). Based on the efficacy results from this study, the lower gastrointestinal side effects and the convenience of twice-a-day dosing, we believe that cefprozil in a dosage of 30 mg/kg/day divided every 12 hours represents a potential alternative for the treatment of acute otitis media with effusion in children.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Haemophilus influenzae; Humans; Infant; Moraxella catarrhalis; Otitis Media with Effusion; Recurrence; Streptococcus pneumoniae

A clinical trial comparing 5 days' treatment with amoxycillin/clavulanate (group A) and a single dose of fosfomycin trometamol (group B) is presented. The study was done in symptomatic patients presenting to their family practitioner, with the microbiological testing being carried out in a university hospital laboratory. Of 62 patients with significant bacteriuria, 29 were given amoxycillin/clavulanate and 33 fosfomycin trometamol, in a randomized fashion. Cure rates 1 week and 5 weeks after the end of treatment were 72 and 65% in group A and 85 and 81% in group B. Adverse events assessed in 141 patients were unusual (10.1% in group A and 8.3% in group B) and were mild in nature. The results of this study suggest that single-dose treatment with fosfomycin trometamol is effective and acceptable as a conventional course of amoxycillin clavulanate for the treatment of simple acute dysuria and/or frequency with infection.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteriuria; Clavulanic Acids; Drug Therapy, Combination; Family Practice; Female; Fosfomycin; Humans; Male; Remission Induction; Time Factors; Urinary Tract Infections

In a prospective randomized open study, 111 young children with otitis media were orally treated during 10 days with Pediazole (50 mg/kg/day in 3 divided doses) or amoxicillin + clavulanic acid (40 mg/kg/day in 3 or 4 divided doses) for efficacy and safety evaluation. 51 children wer assigned to amoxicillin + clavulanic acid (group I) and 60 to erythromycin-sulfisoxazole (group II). Mean age was respectively 24.7 months in group I and 23.4 months in group II. Results of efficacy evaluation were as follows: (table; see text) there was no statistically significant difference between the two treatment groups for efficacy. Overall safety was good. The treatment was discontinued only in four cases (3 in the amoxicillin + clavulanic acid group and 1 in the EES-sulfisoxazole group). In conclusion, Erythromycin sulfisoxazole combination (Pediazole) fits in with current epidemiological profile of Acute Otitis Media and represents a therapy of choice in this indication.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Clavulanic Acids; Drug Combinations; Drug Therapy, Combination; Drug Tolerance; Erythromycin; Female; Humans; Infant; Male; Otitis Media; Prospective Studies; Randomized Controlled Trials as Topic; Recurrence; Sulfisoxazole

In this randomized, blinded, multicenter comparison study, 377 infants and children with acute otitis media (AOM) received a 10-day course of an oral suspension of one of the following: cefuroxime axetil (CAE), 30 mg/kg/day; cefaclor (CEC), 40 mg/kg/day; or amoxicillin-clavulanate potassium (AMX-CL), 40 mg/kg/day. Clinical efficacy was determined by pneumatic otoscopy and tympanometric testing 3 to 5, 11 to 14, and 22 to 26 days after the initiation of therapy. There was a statistically significant difference among the three treatment groups with respect to clinical outcome; more patients in the CAE group (62%) than in the CEC group (46%) or the AMX-CL group (52%) had complete resolution of signs and symptoms of AOM (including effusion). Paired comparisons revealed a significant difference in efficacy between CAE and CEC and a nearly significant difference between AMX-CL and CEC. Taste acceptability was highest for CEC and lowest for this formulation of CAE. Significantly more patients in the AMX-CL group than in the CAE or CEC group had a side effect, primarily diarrhea, vomiting, or diaper rash. We conclude that CAE suspension has greater clinical efficacy than CEC and fewer side effects than AMX-CL.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Cefaclor; Cefuroxime; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Evaluation Studies as Topic; Female; Humans; Infant; Male; Otitis Media; Time Factors

In a prospective study, 105 infants aged 3-12 months with acute otitis media were randomly assigned to one of three treatment groups: amoxycillin/clavulanate ('Augmentin') alone (36 patients), myringotomy plus placebo (35 patients), or augmentin plus myringotomy (34 patients). The last two groups were double-blinded. Bacterial pathogens, mainly Haemophilus influenzae (of which 20% were beta-lactamase producers) and Streptococcus pneumoniae, were isolated from 60% of the ear exudates and all isolates were sensitive to augmentin. Most of the infants improved clinically within 3-6 days irrespective of the treatment protocol. As judged by otoscopy, 60% of the patients receiving augmentin, with or without myringotomy, recovered completely compared with 23% of patients treated with myringotomy plus placebo. Treatment with augmentin was also more effective than myringotomy with regard to persistence of ear infection. In the myringotomy plus augmentin group closure of the incision and resolution of the discharge from the incision site was faster than in the myringotomy plus placebo group. The addition of myringotomy to augmentin did not seem to affect either the persistence of the infection after treatment or the residual middle ear effusion.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Clinical Trials as Topic; Combined Modality Therapy; Diarrhea; Double-Blind Method; Drug Administration Schedule; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies; Random Allocation; Time Factors; Tympanic Membrane

In a multicenter study, Augmentin pediatric suspension was given to 1,227 young children (3 months - 3 years) with otitis media seen in private practice. Patterns of otitis included first episodes, recurrences, and forms that had failed to respond to previous antimicrobial therapy. The study medication was given as a first-line treatment, on the basis of epidemiologic data, in a daily dose of 40 mg/kg for 7 to 10 days. In the 3 months to 3 years age group, two micro-organisms are prevalent, ie. Haemophilus influenzae, which is the most common agent and may produce beta-lactamases (10 to 18% of strains), and Streptococcus pneumoniae. Among our patients, the otitis-conjunctivitis syndrome caused by Haemophilus influenzae was fairly frequent (8.7% of cases). Clinical effectiveness as evaluated between D8 and D11 was good or very good in 91.2% of cases. Tolerance was satisfactory in 83% of patients. Side effects were uncommon and consisted primarily in gastrointestinal symptoms. We point out the potentially deleterious effect of concurrent anti-inflammatory treatment. Acceptability of the suspension was judged satisfactory by the parents in 91.6% of cases. Augmentin proved well-suited to epidemiologic data, outstandingly effective, well tolerated, and easy to use because of its presentation as a pediatric suspension; it is therefore an appropriate first-line drug in the common indication addressed in our study.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Infant; Multicenter Studies as Topic; Otitis Media

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalexin; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Random Allocation

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalexin; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Recurrence

An open randomised comparative trial of the efficacy and safety of Augmentin as against the triple therapy of penicillin-gentamicin-metronidazole in acute salpingitis was conducted in forty women admitted to hospital. Laparoscopy was performed routinely to confirm the diagnosis. The two groups of patients were comparable as to age and clinical and biological symptoms and the severity of the salpingitis (grade I to IV, with the presence or absence of Fitz-Hugh-Curtis syndrome). Treatment was started immediately after the laparoscopy, first by parental route until the patient had been apyrexic for 48 hours. Oral follow-up was then commenced. Twenty women received Augmentin and twenty the triple antibiotic therapy. Specimens for bacteriological study were obtained before treatment (culture of the urine, culture from the IUD and from the cervix, and swabs were taken laparoscopically). This made it possible to identify aerobic and anaerobic organisms. (The gonococcus was found more often in the group treated with triple antibiotics). On discharge, cures had been obtained in 12 women and 6 more were responding out of the Augmentin group. Out of the triple therapy group 8 were cured and 10 were responding. There was one failure in each group (persisting fever). Long-term assessment was carried out in the out-patients three weeks after discharge. 11 out of the 13 reviewed in the Augmentin group and 8 out of the 14 in the triple therapy group were considered as definitely cured. The clinical safety of both treatments was good. These results demonstrate that Augmentin is as effective as the combined therapy in treating acute salpingitis and with the added advantage of its easy use and lower cost.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acids; Drug Therapy, Combination; Female; Gentamicins; Humans; Metronidazole; Penicillins; Salpingitis

In the first part of this study, a correlation between the throat and nasopharyngeal cultures and the etiological agents of sinusitis given in the literature is investigated. No correlation has been found. In the second part, 80 patients is divided randomly into three groups, 23 patients (28.8%) has been given serum physiologic therapy, 34 patients (42.4%) amoxicillin + antihistaminic + nose drops therapy and 23 patients (28.8%) amoxicillin + antihistaminic + nose drops therapy. Statistically significant clavulanate difference has been found in the cure rate between the antibiotic related regimens and serum physiologic therapies (p less than 0.05), but no significance has been found between amoxicillin and amoxicillin clavulanate regimens (p greater than 0.05).

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Immunization, Passive; Male; Maxillary Sinus; Nasopharynx; Pharynx; Random Allocation; Sinusitis

One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cephalexin; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Earache; Female; Fever; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Random Allocation; Recurrence

This study compared the relative effectiveness of two antimicrobial preparations, amoxicillin and amoxicillin-clavulanate potassium (Augmentin), in the treatment of acute maxillary sinusitis in children 2 to 16 years of age. Of 171 children with persistent (ten to 30 days' duration) nasal discharge or daytime cough or both, 136 (80%) had abnormal maxillary sinus radiographs. These children were stratified by age and severity of symptoms and randomly assigned to receive either amoxicillin, amoxicillin-clavulanate potassium, or placebo. After the exclusion of 28 children with throat cultures positive for group A Streptococcus and 15 who did not complete their medication, the remaining 93 children were evaluated: 30 received amoxicillin, 28 received amoxicillin-clavulanate potassium, and 35 received placebo. Clinical assessment was performed at three and ten days. On each occasion, children treated with an antibiotic were more likely to be cured than children receiving placebo (P less than .01 at three days, P less than .05 at ten days). The overall cure rate was 67% for amoxicillin, 64% for amoxicillin-clavulanate potassium, and 43% for placebo.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Ethmoid Sinus; Female; Follow-Up Studies; Humans; Male; Maxillary Sinus; Radiography; Random Allocation; Sinusitis; Surveys and Questionnaires; Time Factors; Transillumination

A total of 150 children with acute otitis media were randomly allocated to treatment with amoxicillin-potassium clavulanate (Augmentin) or with cefaclor. Each drug was given in a daily dosage of approximately 40 mg/kg in three divided doses for ten days. Tympanocentesis done before treatment yielded specimens that contained pneumococcus or Haemophilus sp or both in 67% of specimens. Viridans group streptococci were isolated from 10% of specimens and Branhamella catarrhalis from 6%. Patients were scheduled for follow-up examinations at midtreatment, end of therapy, and at 30, 60, and 90 days. Of the 150 children, 130 were evaluable. Five of 60 patients (8%) treated with cefaclor were considered therapeutic failures because of persistent purulent drainage and isolation of the original pathogen or suprainfection. There were no failures among patients treated with Augmentin (P = .019). Rates of relapse, recurrent acute otitis media with effusion, and persistent middle ear effusion were comparable in the two groups of patients. Diaper rash, or loose stools, or both were significantly more common in children treated with Augmentin (34%) than in those taking cefaclor (12%), but in no case was it necessary to discontinue medication because of these mild side effects (P = .002). Cefaclor therapy was discontinued in one patient because of severe abdominal pain and vomiting. In this study, treatment with Augmentin was superior to treatment with cefaclor in the acute phase of acute otitis media with effusion, but Augmentin produced more adverse effects. The rates of persistent middle ear effusion and recurrent acute otitis media with effusion were comparable with the two regimens.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefaclor; Cephalexin; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Female; Follow-Up Studies; Haemophilus Infections; Humans; Infant; Male; Otitis Media; Otitis Media with Effusion; Pneumococcal Infections; Random Allocation

Acute otitis media (AOM) is a common indication for antibiotics in children. We sought to characterize the frequency of nonguideline concordant antibiotic therapy for AOM in the United States, by agent and duration.. Using national administrative claims data (2016-2019), we identified children aged 6 months to 17 years with an oral antibiotic dispensed within 3 days of a new diagnosis of suppurative AOM. Use of nonguideline concordant agents and durations, defined based on national treatment guidelines, were summarized by age, race, rurality, region, and insurance type. Subsequent oral antibiotic dispensing within the year after AOM diagnosis was also evaluated. We created sunburst diagrams to visualize longitudinal patterns of within-person antibiotic utilization for AOM, by agent and duration.. We identified 789 424 eligible commercially-insured and 502 239 medicaid-insured children. Among commercially insured children, 35% received nonguideline concordant agents for AOM, including cefdinir (16%), amoxicillin-clavulanate (12%), and azithromycin (7%). Fewer children age <2 years received a nonguideline concordant initial agent (27%) compared to age ≥6 years (41%). More children age <2 years received three or more antibiotics over the following year (34% vs. 3% for children age ≥6 years). The most common treatment duration was 10 days for all ages; treatment duration for the initial antibiotic was nonguideline concordant for 95% and 89% of children age 2-5 years and ≥6 years, respectively. Patterns were similar for medicaid-insured children.. Nonguideline concordant antibiotic use is common when treating AOM in children, including use of broad-spectrum agents and longer-than-recommended antibiotic durations.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefdinir; Child; Humans; Infant; Otitis Media; United States

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Drug Therapy, Combination; Humans; Infant; Urticaria

We evaluated antibiotic prescriptions issued for Finnish children with acute sinusitis by a nationwide private outpatient clinic network from 2014-2020. Data were compared before and after updated guidelines in 2018.. The study comprised data on 45 296 children aged 2-17 years with acute sinusitis, namely diagnoses, ages, dates, the doctor's specialty and any antibiotics. We measured compliance with the updated 2018 Finnish guidelines, which recommended amoxicillin or amoxicillin-clavulanic acid for children under 12 years old, with doxycycline as an alternative for 12 years plus.. There were 6621-7585 visits per year for acute sinusitis in 2014-2019 and 2954 in 2020. Antibiotics were prescribed for 37.9%-41.6% of patients during the study years. Amoxicillin, including penicillin, accounted for 35.9% of prescriptions, followed by amoxicillin-clavulanic acid (26.9%). Macrolides accounted for 20.6% and, encouragingly, decreased by 38% from 2014-2019. Doxycycline accounted for 5.3%. Paediatricians, general practitioners (GPs) and ear, nose and throat specialists followed the guidelines in 75.1%, 73.8% and 66.7% of cases, respectively. GPs prescribed antibiotics more often than other physicians.. Antibiotics were prescribed for about 40% of acute sinusitis visits by Finnish children from 2014-2019. Specialities differed with regard to prescribing rates and whether they followed the guidelines.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Doxycycline; Drug Prescriptions; Finland; Humans; Practice Patterns, Physicians'; Respiratory Tract Infections; Sinusitis

Acute sinusitis is one of the most common indications for antibiotic prescribing in children, with an estimated 4.9 million such prescriptions in the US annually. Consensus does not exist regarding the optimal empirical antibiotic.. To compare amoxicillin-clavulanate vs amoxicillin for the treatment of acute sinusitis in outpatient children.. Cohort study of children and adolescents aged 17 years or younger with a new outpatient diagnosis of acute sinusitis and a same-day new prescription dispensation of amoxicillin-clavulanate or amoxicillin in a nationwide health care utilization database. Propensity score matching was used to mitigate confounding.. A new prescription dispensation of amoxicillin-clavulanate or amoxicillin.. Treatment failure, defined as an aggregate of a new antibiotic dispensation, emergency department or inpatient encounter for acute sinusitis, or inpatient encounter for a sinusitis complication, was assessed 1 to 14 days after cohort enrollment. Adverse events were evaluated, including gastrointestinal symptoms, hypersensitivity and skin reactions, acute kidney injury, and secondary infections.. The cohort included 320 141 patients. After propensity score matching, there were 198 942 patients (99 471 patients per group), including 100 340 (50.4%) who were female, 101 726 (51.1%) adolescents aged 12 to 17 years, 52 149 (26.2%) children aged 6 to 11 years, and 45 067 (22.7%) children aged 0 to 5 years. Treatment failure occurred in 1.7% overall; 0.01% had serious failure (an emergency department or inpatient encounter). There was no difference in the risk of treatment failure between the amoxicillin-clavulanate and amoxicillin groups (relative risk [RR], 0.98 [95% CI, 0.92-1.05]). The risk of gastrointestinal symptoms (RR, 1.15 [95% CI, 1.05-1.25]) and yeast infections (RR, 1.33 [95% CI, 1.16-1.54]) was higher with amoxicillin-clavulanate. After patients were stratified by age, the risk of treatment failure after amoxicillin-clavulanate was an RR of 0.98 (95% CI, 0.86-1.12) for ages 0 to 5 years; RR was 1.06 (95% CI, 0.92-1.21) for 6 to 11 years; and RR was 0.87 (95% CI, 0.79-0.95) for 12 to 17 years. The age-stratified risk of adverse events after amoxicillin-clavulanate was an RR of 1.23 (95% CI, 1.10-1.37) for ages 0 to 5 years; RR was 1.19 (95% CI, 1.04-1.35) for 6 to 11 years; and RR was 1.04 (95% CI, 0.95-1.14) for 12 to 17 years.. In children with acute sinusitis who were treated as outpatients, there was no difference in the risk of treatment failure between those who received amoxicillin-clavulanate compared with amoxicillin, but amoxicillin-clavulanate was associated with a higher risk of gastrointestinal symptoms and yeast infections. These findings may help inform decisions for empirical antibiotic selection in acute sinusitis.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Cohort Studies; Female; Humans; Infant; Infant, Newborn; Male; Mycoses; Sinusitis; Treatment Failure

The success rate of non-operative treatment (NOT) of acute uncomplicated appendicitis (AUA) in children varies from 65% to 95%. There are no recommendations on the appropriate antibiotic therapy.. To determine the clinical efficacy of amoxicillin-clavulanic acid for NOT of AUA in children.. Design: Cross-sectional study in a single medical centre.. Emergency department and Paediatric Visceral Surgery department of the Children Hospital in Toulouse, France.. Patients 5-15 years old who were diagnosed with appendicitis, (1) With abdominal pain and a first episode of acute appendicitis, (2) With no radiological or ultrasound evidence of appendicolith, appendiceal perforation, pelvic abscess nor peritonitis, and (3) With non-septic general aspect, were included.. NOT consisted of hospital admission. The antibiotic treatment was a combination of amoxicillin and clavulanic acid (80 mg/kg/day of amoxicillin): intravenous regimen during 48 hours followed by oral route during 7 days.. Success rate of amoxicillin-clavulanic acid NOT in children with AUA at 2 years.. The initial success rate of amoxicillin-clavulanic acid NOT in children with AUA was 100% (104/104 patients). The success rate at 2 years was 85.6% (89/104) at discharge. None of the 15 patients who underwent surgery after recurrence of appendicitis presented with peritonitis, appendiceal perforation nor pelvic abscess.. Narrowed antibiotic therapy with amoxicillin and clavulanic acid seems to be an alternative to surgery in children with AUA. It is necessary to wait for the results of ongoing studies to confirm these results.

Topics: Abscess; Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendicitis; Child; Child, Preschool; Clavulanic Acid; Cross-Sectional Studies; Humans; Peritonitis; Retrospective Studies; Treatment Outcome

The objective of the study was to compare the antibiotic treatment failure and recurrence rates between antibiotic agents (amoxicillin, amoxicillin-clavulanate, cefdinir, and azithromycin) for children with uncomplicated acute otitis media (AOM).. We completed a retrospective cohort study of children 6 months-12 years of age with uncomplicated AOM identified in a nationwide claims database. The primary exposure was the antibiotic agent, and the primary outcomes were treatment failure and recurrence. Logistic regression was used to estimate ORs, and analyses were stratified by primary exposure, patient age, and antibiotic duration.. Among the 1 051 007 children included in the analysis, 56.6% were prescribed amoxicillin, 13.5% were prescribed amoxicillin-clavulanate, 20.6% were prescribed cefdinir, and 9.3% were prescribed azithromycin. Most prescriptions (93%) were for 10 days, and 98% were filled within 1 day of the medical encounter. Treatment failure and recurrence occurred in 2.2% (95% CI: 2.1, 2.2) and 3.3% (3.2, 3.3) of children, respectively. Combined failure and recurrence rates were low for all agents including amoxicillin (1.7%; 1.7, 1.8), amoxicillin-clavulanate (11.3%; 11.1, 11.5), cefdinir (10.0%; 9.8, 10.1), and azithromycin (9.8%; 9.6, 10.0).. Despite microbiologic changes in AOM etiology, treatment failure and recurrence were uncommon for all antibiotic agents and were lower for amoxicillin than for other agents. These findings support the continued use of amoxicillin as a first-line agent for AOM when antibiotics are prescribed.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Cefdinir; Child; Humans; Infant; Otitis Media; Retrospective Studies; Treatment Outcome

Acute appendicitis is the most frequent surgical emergency in the paediatric population. Complicated appendicitis accounts for 30% of cases and is inextricably linked to postoperative infectious complications. A study at our institution showed that amoxicillin-clavulanate resistant Escherichia coli in complicated appendicitis was significantly linked to postoperative infectious complications. These findings led to a change in the empirical antibiotic protocol (amoxicillin-clavulanate changed to ceftriaxone + metronidazole as of 2017), intending to reduce postoperative infectious complications in complicated appendicitis in our institution.. This study aimed to analyse the microbiology and resistance profiles of pathogens of complicated appendicitis at our institution since implementing the new antibiotic protocol and the postoperative infectious complications rate.. We designed a retrospective comparative cohort study. During the defined study period (01 January 2017 to 31 July 2020), medical records were analysed for cases of acute appendicitis, complicated appendicitis and postoperative infectious complications, retaining only those who fulfilled inclusion criteria. Postoperative outcomes, microbiology and antibiotic resistance of peritoneal swabs were analysed.. During the study period, 95 patients presented with a complicated appendicitis, and 11 (12%) developed postoperative infectious complications. The most frequent pathogens found in complicated appendicitis were E. coli (66%), Streptococcus anginosus (45%), and Bacteroides fragilis (22%). Pseudomonas aeruginosa was present in 17% of complicated appendicitis. Pathogens involved in postoperative infectious complications mirrored the distribution found in complicated appendicitis without postoperative infectious complications. Antibiotic susceptibility analysis showed that 10 (15%) of E. coli strains were resistant to amoxicillin-clavulanate but sensitive to ceftriaxone + metronidazole, with only one strain responsible for causing a postoperative infectious complication. Six additional strains of E. coli (9%) were resistant to amoxicillin-clavulanate and our empirical antibiotic regimen but were not associated with an increase in postoperative infectious complications. Compared with our previous study, there was a decrease in postoperative infectious complications from 16% to 12%. Postoperative infectious complications caused by amoxicillin-clavulanate-resistant E. coli decreased from 28% to 9%.. This retrospective study demonstrated a decrease in the rate of postoperative infectious complications due to amoxicillin-clavulanate-resistant E. coli in complicated appendicitis. These findings accentuate the need to implement evidence-based treatment protocols based on local microbiology profiles and resistance rates to optimise post-operative antibiotics in complicated appendicitis.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendectomy; Appendicitis; Ceftriaxone; Child; Clinical Protocols; Cohort Studies; Escherichia coli; Humans; Metronidazole; Postoperative Complications; Retrospective Studies

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Dose-Response Relationship, Drug; Female; Humans; Male; Sinusitis; Time Factors

Treatment options for urinary tract infection (UTI) caused by extended-spectrum beta-lactamase (ESBL)-producing organisms are limited other than carbapenem. Accordingly, clinicians should investigate alternative antimicrobial options for limited infection. This study was performed to assess the efficacy of single-dose amikacin and a 7-day oral regimen of amoxicillin/clavulanate for the treatment of acute cystitis caused by ESBL-producing. A single-dose amikacin and 7-day oral amoxicillin/clavulanate regimen was given to all patients with acute cystitis or recurrent cystitis between May 2016 and October 2018. We conducted a retrospective cohort study assessing the efficacy of this regimen for the treatment of UTI due to ESBL-producing organisms. Both clinical and laboratory efficacy were assessed a minimum of 7 days and a maximum of 14 days after the completion of treatment.. A total of 47 patients were enrolled in this study.. The combination of amoxicillin/clavulanate and amikacin may be an alternative to carbapenem treatment in patients with acute cystitis caused by ESBL-producing Enterobacteriaceae.

Topics: Acute Disease; Aged; Amikacin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cystitis; Drug Administration Schedule; Escherichia coli; Escherichia coli Infections; Female; Humans; Klebsiella Infections; Klebsiella pneumoniae; Male; Middle Aged; Retrospective Studies

To investigate the efficacy and safety of home-treatment with oral piv-mecillinam or amoxicillin-clavulanate in children with acute pyelonephritis.. Children aged over 6 months diagnosed with culture confirmed pyelonephritis at Danish Paediatric Departments were home-treated with piv-mecillinam (tablets) or amoxicillin-clavulanate (liquid or tablets). Follow-up was performed by phone (second treatment day) and clinical review of the patients in the hospital (day three).. Four hundred eighteen children were included. In total, 333/418 (80%) responded well to the initial oral antibiotic treatment. 85/418 (20%) were changed to another treatment of these 47/418 (11%) to a second-line oral antibiotic and 38/418 (9%) to intravenous antibiotics due to insufficient clinical improvement or bacterial resistance. Bacterial resistance was similar for piv-mecillinam and amoxicillin-clavulanate: 4/74 (5%) versus 33/333 (10%) (p = 0.22). Insufficient clinical improvement, despite no resistance, primarily occurred in children treated with piv-mecillinam: 16/74 (22%) versus 28/344 (8%) (p < 0.001), and predominantly occurred in piv-mecillinam treated children <5 years: 7/20 (35%) versus 9/54 (17%) (p < 0.05), potentially because of problems with piv-mecillinam tablets. In the study population no cases of death or septicemia developed after start of initial oral treatment.. A home-treatment regime for pyelonephritis in children >6 months is safe; however, during treatment, clinical re-evaluation is required as in 20% of cases a change in treatment was necessary.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Humans; Infant; Pyelonephritis

The Korean Otologic Society developed guidelines for treatment of acute otitis media (AOM) in 2010, which advocated limiting the prescription of antibiotics. However, it is not known whether this has influenced the antibiotic prescription rate. Thus, this study aimed to examine the impact of these guidelines on the patterns in antibiotic prescription for AOM in Korean children.. AOM patients aged less than 15 years, included in the Korean Health Insurance Review and Assessment Service database from 2009 to 2017, were retrospectively identified. We estimated the overall antibiotic prescription rate, antibiotic prescription rates for suppurative and non-suppurative AOM, and types of antibiotics prescribed. Moreover, we analyzed differences in antibiotic prescription rates according to age group, hospital type, and medical department.. The overall antibiotic prescription rate decreased significantly from 2009 to 2017. The antibiotic prescription rate for non-suppurative AOM decreased much more than the rate for suppurative AOM. Overall, amoxicillin/clavulanate was the most commonly prescribed antibiotic, followed by cephalosporin. The antibiotic prescription rate decreased by a similar margin in all age groups. Tertiary referral hospitals and otorhinolaryngology department showed the lowest antibiotic prescription rate every year.. This study demonstrated the changes in antibiotic prescription rates for AOM following implementation of the Korean AOM treatment guidelines. The practice of antibiotic prescription for children with AOM appears to have decreased every year. However, the overall antibiotic prescription rate is still high. Therefore, clinicians should understand and adhere to the guidelines, and merely observe children with mild AOM symptoms.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media; Practice Patterns, Physicians'; Republic of Korea; Retrospective Studies

Ludwig angina is a life-threatening type of soft tissue cellulitis involving 3 compartments on the floor of the mouth including the submental, sublingual, and submandibular spaces bilaterally. Prevention, early recognition, and treatment of Ludwig angina are critical because this is a clinical diagnosis with unpredictable progression. This article describes a rare case of Ludwig angina that evolved from an odontogenic infection and the specific microbiology and clinical course and discusses possible etiologies and prevention.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Debridement; Dental Care; Dental Pulp Necrosis; Early Diagnosis; First Aid; Humans; Ludwig's Angina; Male; Periapical Abscess; Radiography, Dental; Root Canal Therapy; Tomography, X-Ray Computed; Tracheostomy; Treatment Outcome; Young Adult

This study is a retrospectively recruited case series. We report three infants with acute conjunctivitis induced by β-lactamase-positive, ampicillin/clavulanic acid-resistant strains of Haemophilus influenzae (BLPACR). Patients with BLPACR-positive cultures were recruited from among 5,107 patients with inflammatory diseases of the ocular surface who underwent examinations, including bacterial culturing of conjunctival sac or corneal scrapings, between 2000 and 2015. Three BLPACR-positive patients were recruited, including a 10-month-old boy, a 4-month-old girl, and a 7-month-old girl. All three demonstrated BLPACR conjunctivitis. The clinical findings in these patients included fever, mucopurulent discharge, lid swelling, and conjunctival hyperemia. Samples of conjunctival swabs were obtained from all three infants, and BLPACR was isolated from all these conjunctival swabs. Antimicrobial susceptibility testing showed sensitivity to levofloxacin and resistance to ampicillin, cefaclor, and clarithromycin. We conclude that in infantile BLPACR conjunctivitis, simultaneous investigation for the determination of causative organism and antibiotic susceptibility testing are crucial aspects of the medical treatment.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; beta-Lactamases; Conjunctivitis, Bacterial; Drug Resistance, Multiple, Bacterial; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Levofloxacin; Male; Microbial Sensitivity Tests; Retrospective Studies; Topoisomerase II Inhibitors

Topics: Acute Disease; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Cefazolin; Clinical Decision-Making; Combined Modality Therapy; Debridement; Female; Floxacillin; Hip Prosthesis; Humans; Knee Prosthesis; Male; Microbial Sensitivity Tests; Middle Aged; Netherlands; Practice Patterns, Physicians'; Prosthesis-Related Infections; Retrospective Studies; Staphylococcal Infections

To assess compliance of antibiotic prophylaxis in surgery for acute appendicitis in children and its effect on surgical site infection.. We carried out a prospective cohort study to evaluate compliance of antibiotic prophylaxis in appendectomies in children. An assessment of the level of compliance with prophylaxis was made, as well as the causes of non-compliance. The effect of non-compliance of antibiotic prophylaxis on the incidence of surgical site infection was studied with the adjusted relative risk (RR) with a backstep logistic regression model.. The study included a total of 412 patients. Antibiotic prophylaxis was indicated in 348 patients, and administered in 95.7% of cases, with an overall protocol compliance of 90.7%. The principal cause of non-compliance was time of initiation. Cumulative incidence of surgical site infection was 2.7%. No relationship was found between inadequate prophylaxis compliance and infection (RR: 1.01; 95% confidence interval: 0.95-1.11; p = 0.61).. Compliance of antibiotic prophylaxis was high, but could be improved. No relationship was found between prophylaxis compliance and surgical site infection rate.. Evaluar la adecuación de la profilaxis antibiótica en la cirugía de apendicitis aguda en niños y su efecto en la infección del sitio quirúrgico.. Estudio de cohortes prospectivo para evaluar la adecuación al protocolo de la profilaxis antibiótica en apendicectomías en población infantil. Se evaluaron la administración de la profilaxis y las causas de la inadecuación. Se estudió el efecto de la inadecuación en la incidencia de infección del sitio quirúrgico con el riesgo relativo (RR) ajustado con un modelo de regresión logística por pasos hacia atrás.. Se estudiaron 412 pacientes. La profilaxis antibiótica estaba indicada en 348 pacientes y se administró en el 95.7% de los casos, con una adecuación global al protocolo del 90.7%. La causa principal del incumplimiento fue la hora de inicio. La incidencia acumulada de infección del sitio quirúrgico fue del 2.7%. No se encontró relación entre la adecuación de la profilaxis y la infección del sitio quirúrgico (RR: 1.01; intervalo de confianza del 95%: 0.95-1.11; p = 0.61).. La adecuación de la profilaxis antibiótica fue alta, pero puede mejorarse. No se encontró relación entre la adecuación de la profilaxis antibiótica y la incidencia de infección del sitio quirúrgico.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Antibiotic Prophylaxis; Appendectomy; Appendicitis; Cefazolin; Ceftriaxone; Child; Child, Preschool; Confidence Intervals; Drug Administration Schedule; Female; Gentamicins; Guideline Adherence; Humans; Incidence; Logistic Models; Male; Medication Adherence; Metronidazole; Prospective Studies; Surgical Wound Infection

Orbital complications (OC) secondary to acute rhinosinusitis (ARS) in adults are less common than in children, with assumed worse outcome.. Adults with OC secondary to ARS between 1994 and 2014 were reviewed retrospectively. Parameters recorded included age, gender, clinical symptoms and signs, computed tomography (CT) scan findings, duration of hospitalization, treatment before and during admission, cultures, and outcome.. Thirty-seven adults with a mean age of 34.6 years, 27 males and 10 females, were diagnosed with OC, 19 (51.3%) with subperiosteal orbital abscess (SPOA), and none with orbital abscess/cellulitis or cavernous sinus thrombosis. Twelve patients with SPOA were managed conservatively with Amoxicillin-Clavulanate in most cases, and only 7 (36.8%) underwent surgery. A CT scan was performed in 27 cases revealing rhinosinusitis in all patients, including frontal involvement in 19 (51.3%) patients and sphenoid sinus in 16 (43.2%).. A shift toward conservative treatment in cases of SPOA has long been integrated in the management protocols, mainly in children under 9 years old. The presumed worse prognosis in adults is not supported in our study, and a conservative treatment is urged to be considered in this group of patients albeit the more extensive radiologic involvement of their sinuses.

Topics: Abscess; Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamase Inhibitors; Conservative Treatment; Drainage; Female; Humans; Israel; Male; Orbit; Orbital Cellulitis; Prognosis; Retrospective Studies; Rhinitis; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome

Although prohibited by law and legal regulatory frameworks, non-prescribed sale of antibiotics in community medicine retail outlets (CMROs) remains a serious problem in Ethiopia. The aim of this study was to document the extent of and motivations behind non-prescribed sale of antibiotics among CMROs in Gondar town, Ethiopia.. A 2 phase mixed-methods study (a simulated patient visit followed by an in-depth interview) was conducted among CMROs in Gondar town, Ethiopia. Two clinical case scenarios (acute childhood diarrhea and upper respiratory tract infection) were presented and the practice of non-prescribed sale were measured and results were reported as percentages. Pharmacy staff (pharmacists and pharmacy assistants) were interviewed to examine factors/motivations behind dispensing antibiotics without a valid prescription.. A stringent law and policy enforcement regarding the sale of antibiotics without a valid prescription should be in place. This will ultimately help to shift the current pharmacy practices from commercial and business-based interests/practices to the provision of primary healthcare services to the community.

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Community Pharmacy Services; Diarrhea; Ethiopia; Female; Humans; Interviews as Topic; Male; Motivation; Pharmacists; Prescriptions; Qualitative Research; Respiratory Tract Infections

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefotaxime; Ciprofloxacin; Combined Modality Therapy; Drainage; Drug Therapy, Combination; Female; Humans; Metronidazole; Parotitis; Self Medication; Streptococcal Infections; Tomography, X-Ray Computed; Viridans Streptococci

Septic arthritis of the temporomandibular joint as a complication of acute otitis media is rare in the Western world. This report describes the case of a 7-year-old boy who had pain in his right ear and limited mouth opening, following the onset of acute otitis media. A contrast-enhanced computed tomography scan revealed right-sided mastoiditis and hydrops of the right temporomandibular joint, suggesting septic arthritis. Real-time PCR and microbiologic analysis identified Streptococcus pyogenes and Staphylococcus epidermidis in the joint aspirate. Treatment with arthrocentesis and antibiotics led to full recovery of temporomandibular joint function.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Arthritis, Infectious; Arthrocentesis; Child; Humans; Male; Otitis Media; Radiography, Panoramic; Real-Time Polymerase Chain Reaction; Streptococcus pyogenes; Temporomandibular Joint Disorders; Tomography, X-Ray Computed

The aim of the current study was to compare community-acquired acute pyelonephritis (CA-APN) with health care-associated acute pyelonephritis (HCA-APN), describe the outcomes, and identify variables that could predict antimicrobial susceptibility. We conducted an observational study that included all consecutive episodes of acute pyelonephritis (APN) in adults during 2014 at a Spanish university hospital. From each episode, demographic data, comorbidities, clinical presentation, microbiological data, antimicrobial therapy, and outcome were recorded. A multivariable logistic regression model was performed to define the variables associated with antimicrobial resistance. A total of 607 patients, 503 (82.9%) with CA-APN and 104 (17.1%) with HCA-APN, were included in the study. Patients with HCA-APN were older than patients with CA-APN (70.4 versus 50.6 years;

Topics: Acute Disease; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefotaxime; Cefuroxime; Ciprofloxacin; Cohort Studies; Community-Acquired Infections; Cross Infection; Drug Resistance, Bacterial; Empirical Research; Escherichia coli; Escherichia coli Infections; Female; Hospitals, University; Humans; Logistic Models; Male; Microbial Sensitivity Tests; Middle Aged; Pyelonephritis; Risk Factors; Spain; Trimethoprim, Sulfamethoxazole Drug Combination; Urinary Tract Infections

Acute respiratory tract infections account for the majority of antibiotic exposure in children, and broad-spectrum antibiotic prescribing for acute respiratory tract infections is increasing. It is not clear whether broad-spectrum treatment is associated with improved outcomes compared with narrow-spectrum treatment.. To compare the effectiveness of broad-spectrum and narrow-spectrum antibiotic treatment for acute respiratory tract infections in children.. A retrospective cohort study assessing clinical outcomes and a prospective cohort study assessing patient-centered outcomes of children between the ages of 6 months and 12 years diagnosed with an acute respiratory tract infection and prescribed an oral antibiotic between January 2015 and April 2016 in a network of 31 pediatric primary care practices in Pennsylvania and New Jersey. Stratified and propensity score-matched analyses to account for confounding by clinician and by patient-level characteristics, respectively, were implemented for both cohorts.. Broad-spectrum antibiotics vs narrow-spectrum antibiotics.. In the retrospective cohort, the primary outcomes were treatment failure and adverse events 14 days after diagnosis. In the prospective cohort, the primary outcomes were quality of life, other patient-centered outcomes, and patient-reported adverse events.. Of 30 159 children in the retrospective cohort (19 179 with acute otitis media; 6746, group A streptococcal pharyngitis; and 4234, acute sinusitis), 4307 (14%) were prescribed broad-spectrum antibiotics including amoxicillin-clavulanate, cephalosporins, and macrolides. Broad-spectrum treatment was not associated with a lower rate of treatment failure (3.4% for broad-spectrum antibiotics vs 3.1% for narrow-spectrum antibiotics; risk difference for full matched analysis, 0.3% [95% CI, -0.4% to 0.9%]). Of 2472 children enrolled in the prospective cohort (1100 with acute otitis media; 705, group A streptococcal pharyngitis; and 667, acute sinusitis), 868 (35%) were prescribed broad-spectrum antibiotics. Broad-spectrum antibiotics were associated with a slightly worse child quality of life (score of 90.2 for broad-spectrum antibiotics vs 91.5 for narrow-spectrum antibiotics; score difference for full matched analysis, -1.4% [95% CI, -2.4% to -0.4%]) but not with other patient-centered outcomes. Broad-spectrum treatment was associated with a higher risk of adverse events documented by the clinician (3.7% for broad-spectrum antibiotics vs 2.7% for narrow-spectrum antibiotics; risk difference for full matched analysis, 1.1% [95% CI, 0.4% to 1.8%]) and reported by the patient (35.6% for broad-spectrum antibiotics vs 25.1% for narrow-spectrum antibiotics; risk difference for full matched analysis, 12.2% [95% CI, 7.3% to 17.2%]).. Among children with acute respiratory tract infections, broad-spectrum antibiotics were not associated with better clinical or patient-centered outcomes compared with narrow-spectrum antibiotics, and were associated with higher rates of adverse events. These data support the use of narrow-spectrum antibiotics for most children with acute respiratory tract infections.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cephalosporins; Child; Child, Preschool; Female; Humans; Macrolides; Male; Otitis Media; Pharyngitis; Primary Health Care; Quality of Life; Respiratory Tract Infections; Retrospective Studies; Sinusitis; Streptococcal Infections; Streptococcus pyogenes; Treatment Failure

Nonoperative treatment of acute appendicitis appears to be feasible in adults. It is unclear whether the same is true for children.. Children 5-18 years with <48 h symptoms of acute appendicitis were offered nonoperative treatment: 2 doses of piperacillin IV, then ampicillin/clavulanate ×1 week. Treatment failure (worsening on therapy) and recurrence (after completion of therapy) were noted. Patients who declined enrollment were asked to participate as controls. Cost-utility analysis was performed using Pediatric Quality of Life Scale (PedsQL®) to calculate quality-adjusted life month (QALM) for study and control patients.. Twenty-four patients agreed to undergo nonoperative management, and 50 acted as controls. At a mean follow-up of 14 months, three of the 24 failed on therapy, and 2/21 returned with recurrent appendicitis at 43 and 52 days, respectively. Two patients elected to undergo an interval appendectomy despite absence of symptoms. Appendectomy-free rate at one year was therefore 71% (C.I. 50-87%). No patient developed perforation or other complications. Cost-utility analysis shows a 0.007-0.03 QALM increase and a $1359 savings from $4130 to $2771 per nonoperatively treated patient.. Despite occasional late recurrences, antibiotic-only treatment of early appendicitis in children is feasible, safe, cost-effective and is experienced more favorably by patients and parents.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendectomy; Appendicitis; beta-Lactamase Inhibitors; Child; Child, Preschool; Cost-Benefit Analysis; Drug Therapy, Combination; Feasibility Studies; Female; Humans; Male; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Quality of Life; Recurrence; Treatment Failure

This study sought to compare the antimicrobial susceptibility rates between acute uncomplicated cystitis patients with failed initial antimicrobial treatment, who were considered unresolved cases, and newly presenting acute uncomplicated cystitis patients without recent antimicrobial use within 3 months and to determine whether different treatment strategies should be applied according to recent antimicrobial exposure (RAE). Female acute uncomplicated cystitis patients with Escherichia coli growth, who visited our hospital's urology department from 2010 to 2014, were divided according to RAE. The antimicrobial susceptibility of E. coli was compared between the group with RAE and the group with no antimicrobial exposure (NAE) within 3 months. The total number of acute uncomplicated cystitis patients with E. coli growth was 259: 40 patients comprised the RAE group and 219 patients formed the NAE group. The mean age was significantly older and previous recurrent cystitis history was higher in the RAE group (p < 0.05). Furthermore, the antimicrobial susceptibility of E. coli to amoxicillin-clavulanic acid, cefotaxime, cefoxitin, ciprofloxacin, and trimethoprim-sulfamethoxazole was significantly lower in the RAE group, with susceptibility results of 64.7%/88.0% (RAE/NAE), 77.5%/89.0%, 79.4%/95.3%, 31.3%/64.2%, and 42.5%/70.6%, respectively. RAE was an independent factor for antimicrobial resistance. This study showed that antimicrobial susceptibilities were significantly lower in acute uncomplicated cystitis patients with failed initial antimicrobial treatment, who are defined as unresolved cases. Our results suggest that first-line antimicrobials might show poor efficacy in cases of unresolved, acute uncomplicated cystitis and alternative or secondary antimicrobials should be considered in these cases.

Topics: Acute Disease; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefotaxime; Cefoxitin; Ciprofloxacin; Cystitis; Drug Resistance, Multiple, Bacterial; Escherichia coli; Escherichia coli Infections; Female; Humans; Microbial Sensitivity Tests; Middle Aged; Recurrence; Treatment Failure; Trimethoprim, Sulfamethoxazole Drug Combination

Topics: Acute Disease; Administration, Cutaneous; Amoxicillin-Potassium Clavulanate Combination; Autoimmune Diseases; Dermatologic Agents; Drug Hypersensitivity Syndrome; Facial Dermatoses; Female; Humans; Immunosuppressive Agents; Middle Aged; Ointments; Sinusitis; Tacrolimus; Vitiligo

Otitis media is a more frequent occurrence in children, and the disease may progress from an acute to chronic state if appropriate and timely intervention is not initiated.. A total of 212 children aged 6 months to 10 years were examined and treated for otitis media, in a 13-month hospital-based study.. Acute otitis media was diagnosed in 130 (61.3 per cent) of the patients. There were 82 (38.7 per cent) chronic suppurative otitis media cases. The incidence of acute otitis media and chronic suppurative otitis media in the first year of life was 54.6 per cent and 45.1 per cent respectively. Chronic suppurative otitis media patients were assigned to one of three treatment groups. Recovery occurred in 70.4 per cent of amoxicillin-treated patients, in 88.9 per cent of amoxicillin-clavulanic acid treated patients and in 96.4 per cent of culture and antibiotic sensitivity test patients. Relapses were seen only in the amoxicillin (five cases) and amoxicillin-clavulanic acid (two cases) groups.. The success rate in patients treated with antibiotics makes this option mandatory for an established diagnosis.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Chronic Disease; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Nigeria; Otitis Media; Otitis Media, Suppurative

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendectomy; Appendicitis; Female; Humans; Male; Middle Aged; Prospective Studies; Recurrence; Time Factors; Young Adult

To demonstrate clinical value of clavulanic acid/amoxicillin (CVA/AMPC) 1:14 combination dry syrup for acute bacterial rhinosinusitis (ABRS), the efficacy and safety were evaluated in a multicenter, open-label, uncontrolled study in 27 children with ABRS. The proportion of subjects who were 'cured' at the test of cure as the primary endpoint was 88.5%. In subjects with a major pathogenic bacteria at baseline (i.e., Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) bacterial eradication was achieved in ≥ 80% of the subjects with the exception of β-lactamase non-producing ampicillin resistant H. influenzae: BLNAR and β-lactamase producing ampicillin resistant H. influenzae: BLPAR (β-lactamase producing amoxicillin/clavulanic acid resistant H. influenzae: BLPACR). The MIC of CVA/AMPC (1:14) was not higher than 4 μg/mL for all pathogens except one strain each of BLNAR and BLPAR (BLPACR). Drug-related adverse events were reported in 19% of patients (5/27 patients). All of the reported drug-related adverse events were classified as gastrointestinal disorders that have been commonly reported with antibacterial drugs. These results indicate that CVA/AMPC (1:14) was clinically useful for the treatment of ABRS and is also suggested that was effective especially for the treatment of ABRS in children caused by beta-lactamase-producing bacteria including M. catarrhalis.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactamase Inhibitors; Child; Child, Preschool; Humans; Infant; Rhinitis; Sinusitis

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cutaneous Fistula; Dacryocystitis; Disease Susceptibility; Female; Fistula; Humans; Infant; Infectious Mononucleosis; Lacrimal Apparatus Diseases; Streptococcal Infections; Streptococcus pneumoniae

To determine prognostic factors that independently predict response to antimicrobial therapy in children with acute sinusitis.. A total of 206 children meeting a priori clinical criteria for acute sinusitis who were prescribed antimicrobial therapy by their primary care provider were included. The severity of symptoms in the 8-12 days after treatment was initiated was followed with the use of a validated scale. We examined the univariate and multivariate association between factors present at the time of diagnosis (symptoms, signs, nasopharyngeal culture result, radiograph results) and time to resolution of symptoms. This study was conducted 8-10 years after the 7-valent pneumococcal conjugate vaccination was introduced but before introduction of the 13-valent pneumococcal conjugate vaccination.. Children with proven nasopharyngeal colonization with Streptococcus pneumoniae improved more rapidly (6.5 vs 8.5 median days to symptom resolution) than those who were not colonized with S pneumoniae. Age and radiograph findings did not predict time to symptom resolution.. In children with acute sinusitis, proven nasopharyngeal colonization with S pneumoniae at presentation independently predicted time to symptom resolution. Future randomized, placebo-controlled trials could investigate the usefulness of testing for the presence of nasopharyngeal pathogens as a predictor of response to treatment.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Female; Haemophilus influenzae; Humans; Male; Moraxella catarrhalis; Nasopharynx; Prognosis; Prospective Studies; Sinusitis; Streptococcus pneumoniae

In 2011, new guidelines on antibiotic prescription for acute otitis media (AOM) were published in France to decrease the use of third generation cephalosporins that promote the carriage of extended-spectrum beta-lactamase producing Escherichia coli. Our objective was to assess the impact of the 2011 French recommendations on the type of antibiotics prescribed for AOM.. Fourteen thousand six hundred and sixty-one children, 6 to 24 months of age, presenting with AOM were included in 2 studies, between November 1, 2009 and October 31, 2012. The first one was conducted with the support of 62 private practice pediatricians; the second one was conducted in 7 pediatric emergency departments. Three periods of 1 year each were defined.. Antibiotics were prescribed in 12,471 (85.1%) of cases of AOM during the study period. Amoxicillin prescriptions was multiplied by 25, between the first year (2.6%) and the last year (66.1%). Conversely, prescriptions of cefpodoxime proxetil and amoxicillin-clavulanic acid decreased from 33.6% and 62.0% in the first year to 5.2% and 27.7% in the last year, respectively. This trend was observed in both private practices and in the pediatric emergency departments.. Amoxicillin became the most frequently prescribed antibiotic for AOM in 2012, complying with the 2011 French guidelines, while the proportion of prescribed broad-spectrum antibiotics decreased. Our study highlights the importance of guidelines to decrease the prescription of broad-spectrum antibiotics, a crucial factor in the prevention of antibiotic resistance.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefpodoxime Proxetil; Ceftizoxime; Child, Preschool; Drug Resistance, Microbial; Drug Utilization; Emergency Service, Hospital; France; Guideline Adherence; Humans; Inappropriate Prescribing; Infant; Multicenter Studies as Topic; Otitis Media; Pediatrics; Practice Guidelines as Topic; Practice Patterns, Physicians'; Private Practice

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Bronchitis; Humans; Ibuprofen; Treatment Outcome

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Glucocorticoids; Humans; Male; Psoriasis; Tonsillitis

A 38-year-old man presented with pleuritic chest pain that was present on waking and localised to the left costal margin with no radiation. He was otherwise asymptomatic and denied preceding trauma, heavy lifting, coughing or recent vomiting. Observations and examination were unremarkable; however, a chest radiograph showed a pneumomediastinum. Spontaneous pneumomediastinum (SPM) is a rare condition that tends to follow a benign clinical course. A CT of the chest is generally only indicated if the chest X-ray fails to show an SPM in patients for whom there is a high index of clinical suspicion. A contrast-enhanced swallow study is only indicated if there is suspicion of an oesophageal tear or rupture. Evidence suggests that patients with SPM can be managed conservatively and observed for 24 h.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Analgesics; Chest Pain; Diagnosis, Differential; Emergency Service, Hospital; Humans; Male; Mediastinal Emphysema; Radiography, Thoracic; Risk Assessment; Severity of Illness Index; Treatment Outcome

We sought to determine whether recurrent acute otitis media (rAOM) occurring within 30 days of amoxicillin/clavulanate treatment was caused by bacterial relapse or new pathogens.. Pneumococcal conjugate vaccinated children, age 6-36 months, enrolled in a prospective, longitudinal study experiencing rAOM<1 month after completing amoxicillin/clavulanate therapy were studied. AOM episodes occurred between June 2006 and November 2012. Multilocus sequence typing was used to genotype isolates.. Sixty-six children were in the study cohort; 63 otopathogens were recovered from middle ear fluid after tympanocentesis. Nontypeable Haemophilus influenzae (NTHi) accounted for 47% of initial AOMs versus 15% by Streptococcus pneumoniae (Spn), P<0.0001. NTHi accounted for 42% of rAOM versus 24% by Spn (P value=0.04). NTHi was the main otopathogen that caused true bacteriologic relapses (77%). β-lactamase-producing NTHi and penicillin nonsusceptible Spn were not more common in rAOM than initial AOM infections. Among 21 paired (initial and rAOM events) NTHi isolates genotyped, 13 (61.9%) were the same organism; 1 of 9 (11.1%) of paired Spn isolates was the same (P value=0.017). rAOM occurring within a week of stopping amoxicillin/clavulanate was a different pathogen in 21% of cases, 8-14 days later in 33%, 15-21 days in 41% and 22-30 days in 57% (P=0.04).. In amoxicillin/clavulanate-treated children, NTHi was the main otopathogen that caused true bacteriologic relapses. New pathogens causing rAOM versus persistence of the initial pathogen significantly increased week to week. Neither relapses nor new infections were caused more frequently by β-lactamase producing NTHi or penicillin nonsusceptible Spn.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Cohort Studies; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Logistic Models; Male; Otitis Media; Pneumococcal Infections; Recurrence; Streptococcus pneumoniae

To update the American Academy of Pediatrics clinical practice guideline regarding the diagnosis and management of acute bacterial sinusitis in children and adolescents.. Analysis of the medical literature published since the last version of the guideline (2001).. The diagnosis of acute bacterial sinusitis is made when a child with an acute upper respiratory tract infection (URI) presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever[temperature ≥39°C/102.2°F] and purulent nasal discharge for at least 3 consecutive days). Clinicians should not obtain imaging studies of any kind to distinguish acute bacterial sinusitis from viral URI, because they do not contribute to the diagnosis; however, a contrast-enhanced computed tomography scan of the paranasal sinuses should be obtained whenever a child is suspected of having orbital or central nervous system complications. The clinician should prescribe antibiotic therapy for acute bacterial sinusitis in children with severe onset or worsening course. The clinician should either prescribe antibiotic therapy or offer additional observation for 3 days to children with persistent illness. Amoxicillin with or without clavulanate is the firstline treatment of acute bacterial sinusitis. Clinicians should reassess initial management if there is either a caregiver report of worsening(progression of initial signs/symptoms or appearance of new signs/symptoms) or failure to improve within 72 hours of initial management.If the diagnosis of acute bacterial sinusitis is confirmed in a child with worsening symptoms or failure to improve, then clinicians may change the antibiotic therapy for the child initially managed with antibiotic or initiate antibiotic treatment of the child initially managed with observation.. Changes in this revision include the addition of a clinical presentation designated as “worsening course,” an option to treat immediately or observe children with persistent symptoms for 3 days before treating, and a review of evidence indicating that imaging is not necessary in children with uncomplicated acute bacterial sinusitis.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Disease Progression; Female; Humans; Infant; Male; Observation; Paranasal Sinuses; Prognosis; Respiratory Tract Infections; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome; United States

Recurrence acute otitis media (RAOM) may cause a considerable morbidity and a great parental concern. The aim of this study was to analyze the risk factors that are likely to be responsible for RAOM in infants, and their impact on treatment failure.. A retrospective study on 340 infants with RAOM was conducted. Data were collected from hospital charts. A 10 days course of amoxicillin/clavulanate was used for treatment of recurrence, while surgical management in the form of adenoidectomy and/or myringotomy was reserved for patients with persistent disease. We analyzed various risk factors that may affect the prognosis of RAOM, including: age, prematurity, upper respiratory tract infections (URTI), duration of breastfeeding, use of pacifiers, parental smoking, seasonality, the presence of siblings (family size), gender, adenoid hypertrophy, allergy, and craniofacial abnormalities.. Use of pacifiers, short duration of breastfeeding, older infantile age, winter season, URTI and presence of adenoid hypertrophy were identified as risk factors for RAOM. Treatment failure may be due to adenoid hypertrophy, short duration of breastfeeding and it is more common in older age infants. We did not find a significant association between RAOM and gender, prematurity, exposure to passive smoking, the presence of siblings, allergy, craniofacial abnormalities.. Factors that may cause recurrence of the disease in infant population are use of pacifiers, short duration of breastfeeding, older infantile age, winter season, upper respiratory tract infections and adenoid hypertrophy. Also, treatment failure may be caused by adenoid hypertrophy and short duration of breastfeeding. Good understanding of these factors may help to decrease the recurrence rate and to improve the treatment of the disease.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Breast Feeding; Cohort Studies; Female; Humans; Hypersensitivity; Incidence; Infant; Male; Otitis Media; Pacifiers; Prognosis; Recurrence; Respiratory Tract Infections; Retrospective Studies; Risk Factors; Seasons; Severity of Illness Index; Siblings; Time Factors; Tobacco Smoke Pollution

Early treatment of profound bilateral sensorineural hearing loss with cochlear implantation has become routine, resulting in an increased proportion of children implanted at younger ages. These children are at a relatively high risk for acute otitis media (AOM), and are more likely to develop mastoiditis in the implanted ear. Despite the significant risks associated with mastoiditis, including compromise of the implant, there are no specific guidelines on the management of this population. We propose a treatment algorithm emphasizing early but conservative operative intervention.. A retrospective chart review included eight patients, who experienced mastoiditis, in the context of cochlear implantation at our center from August 2005 to November 2012. During this period 806 implant surgeries were completed.. The median age at which mastoiditis occurred was 37 months, and the mean time from implantation to mastoiditis was 9.56 months. All patients underwent drainage of the middle ear in conjunction with intravenous antibiotics, and two additionally underwent post-auricular incision and drainage.. Recent mastoidectomy may be a risk factor for the development of a post-auricular abscess in children, who develop AOM following cochlear implantation. A treatment algorithm was developed, which emphasizes early operative drainage in conjunction with aggressive antibiotic therapy. Conclusions A consistent approach to the management of mastoiditis in children with cochlear implants has not been established. Rapid initiation of aggressive antibiotic therapy and a low threshold for conservative operative intervention results in effective resolution of infection while allowing preservation of the implant.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefprozil; Cefuroxime; Cephalexin; Cephalosporins; Child; Child, Preschool; Clindamycin; Cochlear Implantation; Cochlear Implants; Drainage; Female; Hearing Loss, Sensorineural; Humans; Infant; Infusions, Intravenous; Male; Mastoiditis; Otitis Media; Prosthesis-Related Infections; Retrospective Studies; Risk Factors

Acute pancreatitis is rare in pregnancy, with an estimated incidence of 1 in 1000-3000 pregnancies. Gallstones are the commonest cause. Mortality and morbidity associated with pancreatitis have declined as diagnosis and management options improve. Presentation usually occurs in the third trimester or early postpartum period with severe epigastric pain, nausea, vomiting, anorexia and fever. Blood investigations show an elevated white cell count and increased liver enzyme concentrations. Ultrasound is safe but has lower sensitivity than computerised tomography for detecting gallstones. Management during pregnancy has traditionally been conservative, followed by cholecystectomy after delivery. Recurrence of pancreatitis during pregnancy may necessitate more urgent surgery. The second trimester is considered the safest for surgery, with early involvement of intensive care as the condition can deteriorate rapidly. We present three cases managed in our unit over a six-month period that illustrate the spectrum of disease and the successful use of a multidisciplinary team approach.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cesarean Section; Cholangiopancreatography, Endoscopic Retrograde; Cholangiopancreatography, Magnetic Resonance; Cholecystectomy; Female; Gentamicins; Humans; Magnetic Resonance Imaging; Pancreas; Pancreatitis; Pregnancy; Pregnancy Complications; Ultrasonography

The first case of Ewingella americana conjunctivitis in an otherwise healthy child is reported. Cultures of the conjunctival purulent exudate taken from both eyes grew E. americana. The infection resolved completely after successful treatment with amoxicillin/clavulanate. E. americana should be considered a rare but potential pathogen causing conjunctivitis.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Conjunctivitis, Bacterial; Enterobacteriaceae; Enterobacteriaceae Infections; Humans; Male

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Therapy, Combination; Humans; Practice Guidelines as Topic; Rhinitis; Sinusitis; Treatment Outcome

The paper presents the results of clinical examination of 114 patients aged 60-88 years with acute odontogenous periostitis receiving treatment in in-patient maxillofacial surgery unit. The dynamic of clinical symptoms is used to carry out the comparative effectiveness study of several peroral antibiotics in elderly patients.

Topics: Acute Disease; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ciprofloxacin; Female; Fluoroquinolones; Humans; Jaw Diseases; Male; Middle Aged; Ofloxacin; Periostitis; Suppuration; Treatment Outcome

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; History, 20th Century; Humans; Infant; Otitis Media; Treatment Outcome

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Otitis Media

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Otitis Media; Watchful Waiting

In-depth knowledge of existing practice is required to inform interventions aimed at antibiotic prescribing quality improvement. We set out to describe the presentation, antimicrobial management and associated outcome of adults presenting in general practice with acute cough/lower respiratory tract infection (LRTI) in Poland.. Observational study of 301 adults with acute cough/LRTI. Clinicians completed a case report form (CRF) describing presentation, history and management and patients completed a symptom diary for up to 28 days after consultation.. Two hundred and twenty-one patients (with CRF and symptom diary completed) were analysed. The median duration of feeling unwell before presentation was 4 days. Clinicians recorded an average of eight symptoms for patients at presentation. Apart from cough, patients most commonly reported feeling generally unwell (91.9%), limitation of normal activities (80.5%), coryza (80.1%) and phlegm production (76.0%). Auscultation abnormalities were present in 55.0%. Overall, medicines were prescribed for 95.0%; 72.4% were prescribed antibiotics [mostly macrolides/lincosamides (38.8%) and amoxicillin/co-amoxiclav (36.3%)) with 11.3% advised to take antibiotics only if still necessary after a specified delay. Mucolytics were prescribed for 61.1%. Antibiotic prescription was strongly associated with a diagnosis of LRTI and the presence of auscultation abnormalities. The median duration of cough after presentation was 8 days.. Antibiotics continue to be frequently prescribed for acute cough/LRTI in Poland, and the decision to prescribe was strongly associated with clinicians' findings of abnormalities on auscultation and diagnosis of LRTI. Delayed prescribing was infrequent. Mucolytics were commonly prescribed despite evidence of no effect.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Auscultation; Cough; Drug Prescriptions; Female; General Practice; Humans; Lincosamides; Logistic Models; Macrolides; Male; Middle Aged; Poland; Practice Patterns, Physicians'; Respiratory Tract Infections; Severity of Illness Index; Time Factors; Treatment Outcome; Young Adult

Topics: Acinetobacter baumannii; Acinetobacter Infections; Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; C-Reactive Protein; Female; Fever; Humans; Leukocyte Count; Neutrophils; Peritonsillar Abscess; Pharyngitis; Tonsillitis

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Child, Preschool; Female; Gentamicins; Humans; Thyroid Gland; Thyroiditis, Suppurative; Ultrasonography

Streptococcus pneumoniae and Haemophilus influenzae are most important respiratory pathogens with increasing antimicrobial resistance among the key pathogens responsible for community-acquired respiratory tract infections and have the potential to limit the effectiveness of antibiotics available to treat these infections. In the present study, a total of 18 isolates of Streptococcus pneumoniae and 9 isolates of Haemophilus influenzae were characterised from specimens obtained from patients of acute respiratory tract infections including otitis media, tonsillitis, bronchitis, pneumonia and sinusitis. In the present study, all the Streptococcus pneumoniae isolates were sensitive to coamoxiclav and to cefixime, while they showed variable resistance to the other antibiotics screened. The degree of resistance to various antibiotics was as follows: Streptococcus pneumoniae showed resistance to cotrimoxazole (66.7%), azithromycin (55.6%), erythromycin (16.7%), chloramphenicol (16.7%), clindamycin (11.1%) and penicillin (11.1%). Haemophilus influenzae showed resistance to cefixime 100%, chloramphenicol 88.9%, penicillin 77.8%, erythromycin 77.8%, cefuroxime 77.8%, azithromycin 77.8%, and clindamycin 11.1%. The present study showed the emergence of variable resistance to penicillin, cotrimoxazole and other antibiotics.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Drug Resistance, Microbial; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Pneumococcal Infections; Respiratory Tract Infections; Streptococcus pneumoniae

Observation without initial antibiotic therapy was accepted as an option for acute otitis media (AOM) management in the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline. The guideline also recommended amoxicillin as the first-line treatment for most children, and analgesic treatment to reduce pain if it was present. Our objective was to compare the management of AOM after publication of the 2004 guideline.. We analyzed the National Ambulatory Medical Care Survey, 2002-2006 (N = 1114), which occurred in US physicians' offices. The patients were children aged 6 months to 12 years who were diagnosed with AOM. The time comparisons were the 30-month periods before and after the guideline. The main outcome was the encounter rate at which no antibiotic-prescribing was reported. Secondary outcomes were the identification of factors associated with encounters at which no antibiotic-prescribing was reported and antibiotic- and analgesic-prescribing rates.. The rate of AOM encounters at which no antibiotic-prescribing was reported did not change after guideline publication (11%-16%; P = .103). Independent predictors of an encounter at which no antibiotic-prescribing was reported were the absence of ear pain, absence of reported fever, and receipt of an analgesic prescription. After guideline publication, the rate of amoxicillin-prescribing increased (40%-49%; P = .039), the rate of amoxicillin/clavulanate-prescribing decreased (23%-16%; P = .043), the rate of cefdinir-prescribing increased (7%-14%; P = .004), and the rate of analgesic-prescribing increased (14%-24%; P = .038).. Although management of AOM without antibiotics has not increased after the publication of the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline, children who did not receive antibiotics were more likely to have mild infections. In accordance with the guideline, the prescribing of amoxicillin and analgesics has increased. Contrary to the guideline, the prescribing of amoxicillin/clavulanate has decreased, whereas the prescribing of cefdinir has increased.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Female; Guideline Adherence; Health Care Surveys; Humans; Infant; Logistic Models; Male; Otitis Media; Pediatrics; Practice Guidelines as Topic; Practice Patterns, Physicians'; United States

The aim of the study was to determine the microbiological profile of acute appendicitis in children.. Prospective descriptive study including children hospitalized for acute appendicitis.. A specimen of the appendice and the peritoneal exudates (if exists) was performed intraoperatively for aerobe bacteriological examination. Anaerobic incubation was not possible in our study.. Eighty children were included. The specimen culture isolated aerobic bacteria in 56 patients (70%). Polymicrobial infection was found in 14 children. Gram-negative bacilli were the most frequently isolated microorganisms (64/70). Escherichia coli was found in 48 children. The resistance rate to amoxicilline-clavulanic acid and to cefazolin was 35%. Pseudomonas aeruginosa susceptible to ticarcillin was detected in seven patients.. In our study, the specimen culture found aerobic bacteria in 70% of cases, especially Gram-negative bacilli. Empiric antibiotherapy in acute complicated appendicitis in children should be efficient against these microorganisms.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Appendicitis; Bacteria, Aerobic; Cefazolin; Child; Colony Count, Microbial; Drug Resistance, Bacterial; Escherichia coli; Exudates and Transudates; Female; Gram-Negative Aerobic Bacteria; Humans; Male; Prospective Studies; Ticarcillin

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis, Chronic; Diagnosis, Differential; Drug Therapy, Combination; Fluoroquinolones; Glucocorticoids; Humans; Practice Guidelines as Topic; Prednisone; Primary Health Care; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Treatment Outcome; Trimethoprim, Sulfamethoxazole Drug Combination

Overuse of broad-spectrum antibiotics is associated with antibiotic resistance. Acute otitis media (AOM) is responsible for a large proportion of antibiotics prescribed for US children. Rates of broad-spectrum antibiotic prescribing for AOM are unknown.. Analysis of the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey, 1998 to 2004 (N = 6,878). Setting is office-based physicians, hospital outpatient departments, and emergency departments. Patients are children aged 12 years and younger prescribed antibiotics for acute otitis media. Main outcome measure is percentage of broad-spectrum antibiotics, defined as amoxicillin/clavulanate, macrolides, cephalosporins and quinolones.. Broad-spectrum prescribing for acute otitis media increased from 34% of visits in 1998 to 45% of visits in 2004 (P < .001 for trend). The trend was primarily attributable to an increase in prescribing of amoxicillin/clavulanate (8% to 15%; P < .001 for trend) and macrolides (9% to 15%; P < .001 for trend). Prescribing remained stable for amoxicillin and cephalosporins while decreasing for narrow-spectrum agents (12% to 3%; P < .001 for trend) over the study period. Independent predictors of broad-spectrum antibiotic prescribing were ear pain, non-white race, public and other insurance (compared to private), hospital outpatient department setting, emergency department setting, and West region (compared to South and Midwest regions), each of which was associated with lower rates of broad-spectrum prescribing. Age and fever were not associated with prescribing choice.. Prescribing of broad-spectrum antibiotics for acute otitis media has steadily increased from 1998 to 2004. Associations with non-clinical factors suggest potential for improvement in prescribing practice.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cephalosporins; Child; Child, Preschool; Drug Utilization; Humans; Infant; Macrolides; Otitis Media; United States

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Etanercept; Exanthema; Female; Humans; Immunoglobulin G; Immunosuppressive Agents; Middle Aged; Receptors, Tumor Necrosis Factor; Stevens-Johnson Syndrome

Topics: Acute Disease; Adrenal Cortex Hormones; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Bronchodilator Agents; Common Cold; Community-Acquired Infections; Comorbidity; Diagnosis, Differential; Drug Therapy, Combination; Dyspnea; Humans; Male; Middle Aged; Pneumonia, Bacterial; Pulmonary Disease, Chronic Obstructive

Retropharyngeal abscess is an uncommon entity that can have severe and even fatal complications if it is not identified and treated early. Clinical and radiologic findings must be considered together prior to surgical drainage of a suspected retropharyngeal abscess. Airway obstruction may require emergent surgical management with tracheotomy. We describe the case of a 22-year-old man with a massive retropharyngeal abscess that was caused by inadequate treatment of acute tonsillitis. He responded well to surgical drainage and empiric antibiotic therapy.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Male; Retropharyngeal Abscess; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis; Young Adult

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Chemical and Drug Induced Liver Injury; Cholestasis; Humans; Male

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Biopsy; Diagnosis, Differential; Drug Eruptions; Exanthema; Humans; Male; Skin Diseases, Vesiculobullous

Non-traumatic nasal septal abscess is rare, commonly seen in patients with poor immunity, and presents as isolated nasal septal abscess. Further, nasal septal abscess complicated with acute sinusitis is rather rare. Very little literature has been generated for non-traumatic nasal septal abscess complicated with acute sinusitis in healthy patients. Prompt diagnosis and adequate treatment will help to prevent the complications associated with nasal septal abscess such as saddle nose and intracranial involvement. Herein, to our knowledge, we present the first case involving an otherwise healthy little girl with nasal septal abscess complicated with acute sinusitis and facial cellulitis.

Topics: Abscess; Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Cellulitis; Cheek; Child; Ethmoid Sinusitis; Eyelid Diseases; Female; Humans; Maxillary Sinusitis; Nasal Obstruction; Nasal Septum; Nose Diseases; Postoperative Care; Streptococcal Infections; Tomography, X-Ray Computed; Viridans Streptococci

Recent studies have questioned the use of prolonged intravenous treatment in neonates with urinary tract infection (UTI). The aim of the present study was to examine the clinical course of neonates with UTI with special attention paid to the rates of bacteremia and meningitis and to determine the efficacy of short-term intravenous antibiotic.. Retrospective review of clinical charts of neonates admitted for UTI. Patients were treated first intravenously with a beta-lactam antibiotic and gentamicin. Treatment was completed orally.. One hundred seventy-two neonates (median age, 19 days) were included. Of 129 blood cultures carried out, 16 (12.4%) were positive. Analysis of cerebrospinal fluid was performed in 75 patients; none of the cultures was positive. Forty-nine patients (28.5%) were treated with ampicillin and gentamicin and 105 (61%) with amoxicillin-clavulanate and gentamicin. The median length of intravenous treatment was 4 days (P25: 3; P75: 6). Oral amoxicillin-clavulanate was used in the continuation phase in 75%. No treatment failure or relapse was detected. Eleven (8.7%) of 126 patients had renal scarring at 6 months.. The clinical course in neonates with UTI treated with short-term intravenous antibiotic followed by oral treatment is highly favorable, both in short and long terms. The absence of meningitis and the good evolution of the associated bacteremias argue in favor of a review of the habitual diagnostic-therapeutic protocol in neonates.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; beta-Lactams; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance, Bacterial; Emergency Service, Hospital; Female; Follow-Up Studies; Gentamicins; Humans; Infant, Newborn; Infusions, Intravenous; Male; Microbial Sensitivity Tests; Retrospective Studies; Risk Assessment; Treatment Outcome; Urinalysis; Urinary Tract Infections

We describe a case of acute ischemia of the 2nd, 3rd and 4th fingers of the right hand secondary to peripheral vascular occlusive disease induced by repeated intra-arterial cocaine injections. The complete occlusion of the distal arteries resolved following treatment with iloprost, a synthetic stable analogue of prostacyclin PGI2, in addition to anticoagulants and antibiotics.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anticoagulants; Arterial Occlusive Diseases; Cocaine-Related Disorders; Drug Therapy, Combination; Hand; Humans; Iloprost; Ischemia; Male; Nadroparin; Peripheral Vascular Diseases; Treatment Outcome; Vasodilator Agents

In this prospective study we compared the efficiency of azithromycin and amoxicillin-clavulanate in treatment of acute sinusitis in children. Seventy patients were included in the age between 5 and 15 years. Beside ENT and pediatricians examination, nasal and throat smear on culture and antibiogram is taken from all the patients, as well as, X-ray of paranasal sinuses and laboratory findings, followed by check-up of nasal and throat smear and X-ray of paranasal sinuses. Azithromycin in single daily dose of 10 mg/kg during three days showed same efficiency as amoxicillin-clavulanate given three times per day in dose of 45 mg/kg during ten days.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Female; Humans; Male; Paranasal Sinuses; Radiography; Sinusitis

The aim of this study was to evaluate the applicability, safety and efficacy of an ambulatory treatment protocol in patients with uncomplicated acute diverticulitis.. All patients diagnosed with uncomplicated acute diverticulitis based on abdominal computed tomography findings during a 2-year period were prospectively included. Patients with vomiting, severe comorbidities, or without an appropriate family environment were excluded. Ambulatory treatment consisted of oral antibiotics for 1 week (amoxicillin-clavulanic 1 g t.i.d. or ciprofloxacin 500 mg b.i.d. plus metronidazole 500 mg t.i.d. in patients with penicillin allergy). A clear liquid diet for the first 2 days and pain control with oral acetaminophen 1 g t.i.d. were also recommended.. Fifty-three patients were diagnosed with uncomplicated acute diverticulitis and 13 patients were excluded. Therefore, ambulatory treatment was initiated in 40 patients. Only two patients (5%) required admission after outpatient therapy was started due to vomiting and persistent abdominal pain, respectively. In both patients, the inflammatory process was successfully resolved by intravenous antibiotic treatment. In the remaining 38 patients (95%), ambulatory treatment was completed without complications.. Ambulatory treatment of uncomplicated acute diverticulitis is safe, effective and applicable in most patients with tolerance to oral intake and with an appropriate family environment.

Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Ciprofloxacin; Data Interpretation, Statistical; Diverticulitis; Female; Follow-Up Studies; Humans; Male; Metronidazole; Middle Aged; Patient Selection; Prospective Studies; Radiography, Abdominal; Safety; Time Factors; Tomography, X-Ray Computed

To determine outcomes in acute otitis media (AOM) according to severity of disease and to assess different initial treatment regimens, 308 with AOM were enrolled and divided into severe (n = 277; 89.9%) and non-severe (n = 31; 10.1%) groups based on symptoms and tympanic membrane changes. Children in the severe group were initially managed with amoxicillin (AMPC) whereas children in the non-severe group were initially managed without antibiotics. Children were monitored on days 1, 5, 10, 14 and 28. Five outcome measures were assessed: disappearance of symptoms at day 5, resolution of tympanic membrane changes by day 28, disappearance of middle ear effusions by day 28, recurrence of acute symptoms prior to day 28, and need to change treatment regimens. Children with severe disease were more often male (57% versus 36%, P < 0.05) and more often colonized with pathogens (77% versus 55%, P < 0.05 than children with non-severe disease. The two groups were similar with respect to age and day care attendance. Despite differences in initial treatment regimens between the two groups, symptoms improved at the same rate for severe and non-severe disease, 94% by day 5. In contrast, tympanic membranes returned to normal in 69% of the severe and 81% of the non-severe groups by day 28; however, as early as day 5, 10% of the severe and 55% of the non-severe groups demonstrated normal tympanic membranes. Middle ear effusions similarly disappeared more slowly in the severe group, 52% versus 74% by day 14 and 76% versus 84% by day 28. Recurrence rates of acute symptoms occurred with equal frequency in the severe, 15%, and non-severe groups, 10%. Failure of the symptoms or the tympanic membranes to improve led to antibiotic changes in 59.9% of the severe group and to the addition of antibiotics in 51.6% of the non-severe group. Children in the severe group who failed to improve with an initial course of amoxicillin were younger (40.2 months versus 45.8 months, P < 0.05), had higher tympanic membrane scores (4.5 versus 4.1, P < 0.05), and were more often colonized with penicillin-resistant Streptococcus pneumoniae (33.8% versus 6.5%, P < 0.01) than children who responded to AMPC. In a similar manner, children with non-severe disease who failed to improve without antibiotics were younger (40.7 months versus 54.8 months, P < 0.05) and more often colonized with pathogens (75.0% versus 33.4%, P < 0.05).. Severe disease occurred more often among males and among children colonized with pathogens. Response to treatment was impaired in younger children and in children colonized with pathogens, especially penicillin-resistant Streptococcus pneumoniae.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Epidemiologic Methods; Female; Humans; Infant; Male; Nasopharynx; Otitis Media; Pneumococcal Infections; Sex Factors; Treatment Outcome

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Blood Vessel Prosthesis; Cellulitis; Cloxacillin; Confusion; Diabetes Mellitus, Type 2; Diabetic Foot; Drug Therapy, Combination; Femoral Artery; Hallucinations; Humans; Ischemia; Leg; Male; Popliteal Artery; Prosthesis-Related Infections; Radiography; Staphylococcal Infections; Vitamin B 12 Deficiency

The growing resistance of Streptococcus pneumoniae to penicillin can be overcome by increasing the dose of the penicillin administered. This generated the recommendation that the adult dose of amoxicillin for the treatment of acute maxillary sinusitis (AMS) be increased from 1.5 g/day to 4.0 g/day. The objective of this study was to investigate whether the higher dose of amoxicillin is more effective than the previously recommended dose in eradicating S. pneumoniae from the nasopharynx of patients who present with AMS. Nasopharyngeal cultures obtained from 58 patients with AMS were studied: 30 received amoxicillin 1.5 g/day given in divided doses three times a day for 10 days (amoxicillin/clavulanic acid 4:1 formulation) and 28 were treated with amoxicillin 4.0 g/day given in divided doses twice a day for 10 days (amoxicillin/clavulanic acid 16:1 formulation). Seventy-one potentially pathogenic organisms were isolated: S. pneumoniae (27 isolates), Haemophilus influenzae non-type b (25), Moraxella catarrhalis (5), Streptococcus pyogenes (5) and Staphylococcus aureus (9). The number of S. pneumoniae isolates in the 1.5 g/day group was reduced from 14 to 9 (2 intermediately resistant and 3 highly resistant). In contrast, the number of S. pneumoniae isolates in the 4.0 g/day group was reduced from 13 to 2 (1 highly resistant) (P<0.05). No differences were noted in the eradication rate of other groups of isolates, which were all susceptible to amoxicillin/clavulanic acid. These data illustrate the superiority of 4.0 g/day amoxicillin/clavulanic acid compared with 1.5 g/day amoxicillin/clavulanic acid in the eradication of S. pneumoniae from the nasopharynx.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Dose-Response Relationship, Drug; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Maxillary Sinusitis; Middle Aged; Moraxella catarrhalis; Moraxellaceae Infections; Nasopharynx; Pneumococcal Infections; Staphylococcal Infections; Streptococcal Infections; Streptococcus pyogenes

The effect on the nasopharyngeal flora of 7 days of amoxicillin-clavulanate or 5 days of 800 mg once a day was studied in 50 adults with acute sinusitis. The numbers of potential pathogens and interfering alpha-hemolytic streptococci were equally reduced after both therapies. However, the number of interfering Prevotella spp. declined more significantly after amoxicillin-clavulanate treatment.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Female; Haemophilus influenzae; Humans; Ketolides; Male; Maxillary Sinusitis; Middle Aged; Moraxella catarrhalis; Nasopharynx; Prevotella; Streptococcus pneumoniae

To describe patterns observed in the treatment of acute otitis media (AOM) in several locations of five countries.. Cross-sectional, descriptive study. Random sample of 12,264 paediatric outpatients seen by paediatricians or general practitioners (GPs). Data on patient demographics, diagnoses and treatment were collected. Diagnoses were coded by ICD-9 and drugs by ATC classification. Patients diagnosed with AOM (ICD-9 codes: 381 and 382) were selected for analysis.. Cases of AOM (873) accounted for 7.1% of the sample. There is a clear variation in the percentage of children diagnosed with AOM and treated with antibiotics in the different locations, antibiotic prescriptions being higher in Barcelona (93% of children), and lowest in Smolensk (56.4 % of children were treated without antibiotics). The antibiotics used varied widely: ampicillin use is almost limited to Smolensk (26.7%) and Bratislava (13.8%), whereas amoxicillin plus clavulanic acid is the choice in Toulouse (33.8%), Valencia (30.2%) and Barcelona (28.9%), and cephalosporins are more frequently prescribed in Tenerife (51.7%). Finally, macrolides are used in Barcelona (18.3%), Valencia (17.5%) and Tenerife (13.6%), but not prescribed in Toulouse or Sofia. Prescriptions of anti-inflammatory drugs were only relevant in Valencia (31.7%), Tenerife (27.2%) and Toulouse (17.4%) and of otological preparations in Sofia, where almost each child received ear drops (91.9%). Nasal preparations are commonly used only in Sofia (41.9%), Bratislava (65.5%) and Smolensk (68.6%).. Despite the general agreement of most guidelines, wide differences in the treatment of uncomplicated AOM in children are observed. Non-antibiotic therapy for AOM and the use of first-choice antibiotics should be more actively encouraged in the primary care centres. Studies to measure prevailing rates of antibiotic resistance in these populations are needed.

Topics: Acute Disease; Administration, Topical; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents; Cephalosporins; Child; Cross-Sectional Studies; Drug Prescriptions; Drug Utilization Review; Europe; Europe, Eastern; Humans; International Classification of Diseases; Macrolides; Otitis Media; Practice Patterns, Physicians'

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Drug Therapy, Combination; Humans; Patient Selection; Research Design; Respiratory Tract Infections; Rhinitis; Sinusitis; Treatment Failure

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Drug Therapy, Combination; Humans; Rhinitis; Sinusitis; Treatment Outcome

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Drug Therapy, Combination; Humans; Rhinitis; Sinusitis; Treatment Outcome

Efficacy and safety of amoxiclav (amoxicillin clavulanate) and ampicillin were studied in antibacterial therapy of acute sinusitis. Antibacterial efficacy of amoxiclav in acute sinusitis reached 100%. Its safety was good. Antibacterial efficacy of ampicillin was 76%; 24% patients retained symptoms of the disease, x-ray picture of sinusitis. Its toxicity was higher.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Sinusitis

Nasopharyngeal cultures were obtained from 60 children with acute otitis media before and after treatment with either 45 or 90 mg of amoxicillin (given as amoxicillin-clavulanate) per kg of body weight per day for 10 days. The number of Streptococcus pneumoniae isolates in the 45-mg/kg group was reduced from 12 to 6 and was reduced from 14 to 1 (P = 0.0261) in the 90-mg/kg group.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Nasopharynx; Otitis Media; Penicillins; Pneumococcal Infections; Streptococcus pneumoniae

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Combined Modality Therapy; Drug Therapy, Combination; Ethmoid Sinusitis; Humans; Injections, Intravenous; Maxillary Sinusitis; Preoperative Care

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Community-Acquired Infections; Delayed-Action Preparations; Diarrhea; Drug Therapy, Combination; Humans; Pneumococcal Infections; Randomized Controlled Trials as Topic; Sinusitis

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Diarrhea; Drug Therapy, Combination; Humans; Randomized Controlled Trials as Topic; Sinusitis; Treatment Failure

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; Bites and Stings; Dogs; Exanthema; Female; Humans; Skin Diseases, Vesiculobullous

Acute suppurative thyroiditis is an uncommon disease in children. This paper describes the clinical characteristics and management of children with acute suppurative thyroiditis treated during a 15-year period at National Taiwan University Hospital.. From 1985 to 2000, acute suppurative thyroiditis was diagnosed in 11 previously healthy children (6 boys, 5 girls) at the Department of Pediatrics. Their mean age at diagnosis was 6.4 +/- 4.4 years. Leukocyte count, acute-phase reactants, thyroid function, and thyroid autoantibodies were assessed. Samples were taken by thyroid needle aspiration for cytology study and pus culture. Underlying pyriform sinus fistula (PSF) was demonstrated by barium esophagogram.. Leukocytosis was noted in six cases (55%) and acute-phase reactants were elevated in eight cases (73%). Neither thyroid autoantibodies nor thyroid dysfunction was detected in any of the patients. Barium esophagogram detected PSF in eight of 10 patients examined. Five (45%) patients had recurrent suppurative thyroiditis before surgery. Cytology and pus cultures were available for 10 patients. Polymorphonuclear cells were the main findings in the smear from thyroid aspirates. Twenty-two organisms were isolated from six patients (60%). Streptococcus species (45%) and anaerobic organisms (41%) were the most common pathogens isolated. Mixed infection was detected in five of six children who had a causative microorganism identified. The microorganisms were all sensitive to amoxicillin-clavulanate.. PSF plays a role in the pathogenesis of acute suppurative thyroiditis in children. Streptococcus species are the most common pathogens in acute suppurative thyroiditis. Our results suggest that amoxicillin-clavulanate is the drug of choice for the treatment of this disease.

Topics: Acute Disease; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Female; Fistula; Humans; Infant; Male; Thyroiditis, Suppurative

The effects of co-amoxiclav (AMC) and amoxicillin (AMX) therapy on the nasopharyngeal flora of children with acute otitis media (AOM) were compared. Nasopharyngeal culture for aerobic and anaerobic bacteria were obtained before therapy and 2-4 days after completion of antimicrobial therapy in 25 patients treated with either antibiotic. After therapy, 16 (64%) of the 25 patients treated with AMX and 23 (92%) of the 25 patients treated with AMC were considered clinically cured. Polymicrobial aerobic-anaerobic flora were present in all instances. A significant reduction in the number of both aerobic and anaerobic isolates occurred after therapy in those treated with AMX (177 isolates versus 133, P< 0.005) and AMC (172 isolates versus 60, P< 0.001). However, the number of all isolates recovered after therapy in those treated with AMC was significantly lower (60 isolates) than in those treated with AMX (133 isolates, P < 0.001). The recovery of known aerobic pathogens (e.g. Streptococcus pneumoniae, Staphylococcus aureus, beta-haemolytic streptococci, Haemophilus species and Moraxella catarrhalis) and penicillin-resistant bacteria after therapy was lower in the AMC group than in the AMX group (P < 0.005). This study illustrates the greater ability of AMC, compared with AMX, to reduce the number of potential nasopharyngeal pathogens and penicillin-resistant bacteria in children with AOM.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; beta-Lactamases; Drug Therapy, Combination; Humans; Nasopharynx; Otitis Media; Penicillin Resistance; Penicillins

To determine the current management of acute otitis media by New Zealand general practitioners (GPs).. A reply-paid questionnaire was sent to 2000 New Zealand GPs. The questions relate to management of a three year old child presenting with her first episode of acute otitis media.. 95% of respondents reported they would usually or always use antibiotics. Amoxicillin was the antibiotic of choice, followed by amoxicillin/clavulanate. Cotrimoxazole was the antibiotic of choice in the case of allergy to amoxicillin. 82% of respondents recommended follow-up, with a broad range of follow-up times (24 hours to 12 weeks). Approximately half of practitioners considered 5-6 episodes of acute otitis media in a year as an appropriate threshold for referral for grommets. Most GPs had received an update on otitis media within the previous two years.. There is considerable variation in the management of acute otitis media by New Zealand GPs. Use of a national guideline may result in a more standardised, rational approach to the treatment of acute otitis media.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Child, Preschool; Drug Therapy, Combination; Humans; New Zealand; Otitis Media; Penicillins; Physicians, Family; Practice Patterns, Physicians'; Surveys and Questionnaires; Trimethoprim, Sulfamethoxazole Drug Combination

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Arthritis, Infectious; Child; Drug Therapy, Combination; Hip; Humans; Male; Pyelonephritis; Vancomycin

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Drug Hypersensitivity; Drug Therapy, Combination; Exanthema; Humans; Male; Patch Tests

Recurrent acute tonsillitis, peritonsillar infections and quinsy (peritonsillar abscess) are common clinical conditions that present to a general practitioner. Management in general practice and in hospital is confounded by apparently conflicting treatment options in the medical literature. We have developed clear guidelines as part of an ongoing audit cycle which include performing quinsy or 'hot' tonsillectomy in selected cases, alongside conservative treatments to ensure the speedy recovery and minimal hospitalisation of all patients, with resultant cost benefits.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Biopsy, Needle; Drug Therapy, Combination; Female; Humans; Length of Stay; Male; Metronidazole; Middle Aged; Peritonsillar Abscess; Practice Guidelines as Topic; Recurrence; Retrospective Studies; Tonsillectomy; Tonsillitis; Treatment Outcome

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Drug Administration Schedule; Humans; Sinusitis; Treatment Outcome

Sparse recent data are available in the United States regarding the pathogens of acute otitis media (AOM) most likely to be recovered from children recently treated with the two most frequently prescribed antibiotics, amoxicillin or amoxicillin/clavulanate (AMC).. Of the 704 rural Kentucky children with culture-positive AOM who underwent a single tympanocentesis or culture of otorrhea between 1992 and 1998, 96 pathogens were recovered from 90 children during therapy or within 7 days posttherapy with an aminopenicillin. Identification and susceptibility testing of AOM pathogens were performed by routine National Committee for Clinical Laboratory Standards methods.. Pathogens recovered from children with AOM recently treated (0 to 7 days) with amoxicillin (n = 38) and AMC (n = 58), respectively, were as follows: Haemophilus influenzae (beta-lactamase-negative), 16 and 29%; H. influenzae (beta-lactamase-positive), 11 and 22%; penicillin-susceptible Streptococcus pneumoniae, 26 and 12%; intermediately penicillin-nonsusceptible S. pneumoniae (PNSP), 20 and 10%; resistant PNSP 13 and 17%; Moraxella catarrhalis (beta-lactamase-positive), 13 and 7%; and Streptococcus pyogenes, 3 and 2%. H. influenzae was also isolated from 8 (75%) of 12 children treated with high dose AMC ( approximately 80 mg/kg/day amoxicillin component). Significantly fewer children recently treated with amoxicillin were otitis-prone than those given AMC (24% vs. 74%, P < 0.0001).. The predominant pathogen recovered from children with AOM recently treated with amoxicillin was S. pneumoniae (59%) rather than beta-lactamase-producing organisms (24%). H. influenzae was the predominant (51%) pathogen, rather than PNSP (27%), recovered from children recently treated with AMC.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactam Resistance; Child; Child, Preschool; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media with Effusion; Penicillins; Retrospective Studies; Streptococcus pneumoniae; Streptococcus pyogenes

The efficacy of amoxicillin/clavulanate and cefuroxime was determined in a gerbil model of otitis media with a mixed Streptococcus pneumoniae plus Haemophilus influenzae middle ear (ME) infection. Results were compared with those obtained in a previous single H. influenzae model. All untreated animals inoculated with the mixed inoculum developed acute otitis media (AOM), whereas 86.7% of those inoculated with H. influenzae developed otitis media with effusion (OME). Antibiotics eradicated H. influenzae from the ME more efficiently in AOM than in OME, and this difference was highly significant (P80% of animals developed culture-negative OME.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Animals; Cefuroxime; Cephalosporins; Colony Count, Microbial; Disease Models, Animal; Drug Therapy, Combination; Female; Gerbillinae; Haemophilus Infections; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Otitis Media; Otitis Media with Effusion; Pneumococcal Infections; Streptococcus pneumoniae

The diagnosis of acute sinusitis has been regarded as a serious condition that requires the use of antibiotics. However the increasing incidence of resistant organisms means antibiotics need to be used carefully.. To look at the evidence available regarding antibiotic use for sinusitis, and to discuss its application to general practice.. There have been surprisingly few randomised double blind placebo controlled trials for sinusitis, and fewer still have been based in a representative population of primary care patients. This article discusses studies relevant to general practice. Several practical clinical symptoms and signs have been shown to increase the likelihood of a patient having acute bacterial sinusitis, and therefore benefit from antibiotics. When antibiotics are used, comparative data suggest that amoxycillin should be used first line. The issue of patient experience, expectations and satisfaction is also raised.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Drug Therapy, Combination; Endoscopy; Humans; Patient Selection; Penicillins; Randomized Controlled Trials as Topic; Sinusitis; Time Factors; Tomography, X-Ray Computed; Trimethoprim, Sulfamethoxazole Drug Combination

This study aims to ascertain the variability in the use of antibiotics for the treatment of acute respiratoryinfections in several hospital emergency services in Spain, as well as the appropriateness of antibiotics prescription through evaluation by a panel of experts using available scientific evidence.. A cross-sectional study was carried out in the emergency services of 10 hospitals in different Spanish regions. We chose patients diagnosed as having acute respiratory infection, aged over 14 years. Among the collected variables were: type of respiratory infection, antibiotic prescription, comorbidity, qualification of the prescribing doctor and hospital admission. The consensus conference held by a panel of experts established first choice treatment and the alternative and inappropriate use for each respiratory infection, based on the available scientific evidence. All the observed prescriptions in our study were classified according to this pattern.. A sample of 2899 acute respiratory infections was studied (5.5% of all emergencies). Antibacterial agent treatment was prescribed in 82.6% of these, varying according to the infection between 98.5% of pneumonias and 49% of croup-influenza-common cold. The most commonly used antibiotics were amoxicillin-clavulanate and cefuroxime. The global percentage of inappropriate prescription was 40.5% (95% CI; 35.4-45.5). The prescriptions were inappropriate in 16.9% of cases of pharyngotonsillitis, 17.8% of chronic bronchitis, 26.9% of acute bronchitis, 29.3% of pneumonias, 30.8% of otitis and sinusitis and in 70.8% of croup, flu, common cold and non-specified infections. Significant variability among participating centres was observed, both in choice of antibiotics and in their degree of appropriateness.. There is excessive use of antimicrobial drugs in acute respiratory infections, and the majority are used for viral infections. There is indiscriminate use of broad spectrum antibiotics, which are valid in some infections but clearly inappropriate in others. Similarly, there are important differences in the choice of antibiotics and their degree of appropriateness among hospitals.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Cluster Analysis; Consensus Development Conferences as Topic; Cross-Sectional Studies; Drug Prescriptions; Emergency Medical Services; Female; Humans; Male; Middle Aged; Otitis; Respiratory Tract Infections; Retrospective Studies; Spain

To know the variability of treatment of acute otitis media in Spain and the appropriateness of such with respect to consensus.. A descriptive, multicentre, prospective study was carried out in the services of 11 Spanish hospitals. Children diagnosed with acute otitis media and treated on 30 days selected randomly between January and June 1997 were included. An analysis of treatment variability was made. The results were compared with consensus conference of a panel of experts.. Out of the 29436 emergencies studied on 30 days, 821 were diagnosed with acute otitis media. Fifteen point seven percent of the cases were already receiving antibiotics (22% amoxicillin clavulanate, 20% amoxicillin and 11% cefuroxime axetil). For the treatment, at discharge, of the 93% an antibiotic was prescribed (amoxicillin clavulanate in 41%, amoxicillin in 15%, cefuroxime axetil in 11%, cefaclor 6% and azithromycin 5%). Two point eight percent of the children were admitted. According to the guidelines of the panel of experts consulted, appropriateness was 61% for antibiotics of first choice, 12% for drugs of alternate use and 25% for inadequate treatment. The different hospitals presented significant variability in the type of antibiotic used and the appropriateness of such.. Acute otitis media is treated with antibiotics in 93% of the cases diagnosed in Spanish hospitals. The most commonly used antibiotics are amoxicillin clavulanate and amoxicillin alone. The prescription and its appropriateness present significant variability in the different hospitals studied.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Cephalosporins; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Penicillins; Practice Guidelines as Topic; Prospective Studies

papG is the Gal(alpha1-4)Gal-specific adhesin gene of Escherichia coli P fimbriae. The three alleles of papG are associated with different receptor-binding preferences, occur in different lineages of E. coli and appear differentially associated with specific clinical syndromes, e.g. allele II with pyelonephritis and allele III with cystitis. However, no data are available regarding associations of the papG alleles with clinical outcomes.. Alleles I, II and III of papG were sought among 38 E. coli urine isolates from children with acute cystitis by a polymerase chain reaction-based assay. The papG genotype was compared with other bacterial characteristics and with response to therapy.. papG was detected in 13 (34%) strains. It was associated positively with sfa and hly (which encode S fimbriae and hemolysin) and negatively with afa (which encodes Dr-binding adhesins). Allele II predominated over allele III (29% of strains, vs. 5%; P < 0.01). Allele II was significantly associated with serogroups O1 and O16 and with agglutination of both human and sheep erythrocytes, whereas allele III was associated with sfa, hly, serogroup 06 and preferential agglutination of sheep erythrocytes. The presence of papG predicted recurrent bacteriuria among children receiving 3-day treatment and Allele III predicted same-strain recurrence.. These findings conflict with existing data associating allele III with cystitis, confirm and extend previous associations of papG alleles II and III with other bacterial properties and suggest that papG genotype may predict clinical outcomes.

Topics: Acute Disease; Adhesins, Escherichia coli; Alleles; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Cystitis; Electrophoresis, Gel, Pulsed-Field; Escherichia coli; Escherichia coli Infections; Female; Fimbriae Proteins; Genes, Bacterial; Humans; Male; Polymerase Chain Reaction; Serotyping; Treatment Outcome; Urine

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Biopsy; Chemical and Drug Induced Liver Injury; Cholangitis; Drug Therapy, Combination; Humans; Liver; Male

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ceftriaxone; Cephalosporins; Child; Drug Resistance, Microbial; Drug Therapy, Combination; Humans; Otitis Media; Practice Patterns, Physicians'; Streptococcus pneumoniae

Increase of acute liver injury in patients taking amoxicillin-clavulanic acid (co-amoxiclav) as compared to those taking amoxicillin has been suggested. To further investigate the potential hepatotoxicity of the two drugs a historical cohort study was conducted in the Italian region of Friuli-Venezia Giulia. One hundred and eighteen potential cases of acute liver injury were identified through the regional hospital information system and medical records were reviewed for all of them. Overall, 12 cases of acute liver injury were identified: 3 cases occurred in the amoxicillin exposure category, 2 among co-amoxiclav group, and 7 in the non-use category. The adjusted estimate of the rate ratio was 5.7 (CI 95% 1.5-22.1) among users of amoxicillin alone and 6.2 (CI 95% 1.3-29.7) among users of co-amoxiclav.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Chemical and Drug Induced Liver Injury; Cohort Studies; Drug Therapy, Combination; Female; Hospitalization; Humans; Incidence; Italy; Male; Middle Aged; Penicillins; Risk

Since first description in 1988, numerous cases of amoxycillin-clavulanic acid hepatotoxicity have been reported. Most of them are cholestatic hepatitis. A case of acute hepatocellular injury by amoxycillin-clavulanic acid is reported in a 23-years-old male, with a favourable outcome after 18 weeks.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Humans; Male

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Audiometry; Bone Conduction; Cefuroxime; Cephalosporins; Ciprofloxacin; Drug Therapy, Combination; Facial Paralysis; Female; Follow-Up Studies; Glucocorticoids; Hearing Loss; Hearing Loss, Conductive; Humans; Male; Middle Aged; Otitis Media; Penicillins; Prednisone; Trimethoprim, Sulfamethoxazole Drug Combination; Tympanic Membrane

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Otitis Media with Effusion; Penicillins

Recently, it has been demonstrated that paranasal sinuses are an important site of nitric oxide (NO) production in the upper airways. The aim of this study was to evaluate the NO nasal concentration in children with acute maxillary sinusitis before and after treatment with antibiotic therapy. We performed NO nasal measurements in 16 children 4 to 13 yr of age with acute maxillary sinusitis and compared values with 16 age- and sex-matched healthy control subjects. The diagnosis of acute sinusitis was done by clinical signs and symptoms in addition to radiographic examination. NO nasal concentrations were measured by a chemiluminescence analyzer. Nasal NO steady state during oral breathing was recorded. The mean +/- SEM NO nasal concentration in children with sinusitis was 70 +/- 8.7 parts per billion (ppb) and increased significantly to 220 +/- 15 ppb (p < 0.001) after antibiotic therapy (amoxicillin/clavulanate). NO values after recovery from sinusitis were similar to those of healthy control subjects (245 +/- 15 ppb, p = NS). NO nasal measurements were also performed before and after antibiotic treatment in nine children 4 to 12 yr of age with symptoms of upper respiratory tract infection but no symptoms of sinusitis. In these children NO nasal levels were 249 +/- 32 ppb and did not change (p = NS) after antibiotic therapy. We conclude that during acute maxillary sinusitis the concentration of nasal NO is largely decreased, probably because of an impaired flow of NO from the paranasal sinuses, and that NO returns to normal levels after antibiotic therapy.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Maxillary Sinusitis; Nasal Mucosa; Nitric Oxide; Respiratory Tract Infections

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Resistance, Microbial; Drug Therapy, Combination; Europe; Female; Humans; Infant; Israel; Male; Microbial Sensitivity Tests; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae; United States

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftriaxone; Cephalosporins; Child; Clavulanic Acids; Drug Therapy, Combination; Humans; Otitis Media; Parents; Treatment Failure

A case of cholestatic jaundice following treatment with Augmentin is reported. The awareness of hepatotoxicity due to drug should help to avoid unnecessary invasive procedures in the evaluation of this reversible condition.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cholestasis; Clavulanic Acids; Drug Therapy, Combination; Humans; Male; Middle Aged; Pancreatitis

This study was designed to test the in-vitro activity of four oral antibiotics against the four microorganisms most frequently isolated in acute otitis media: beta-lactamase-positive Haemophilus influenzae (N = 10), beta-lactamase-positive Moraxella catarrhalis (N = 10), penicillin-sensitive Streptococcus pneumoniae (N = 11) and methicillin-sensitive Staphylococcus aureus (N = 10), by the bactericidal curve method. Bactericidal kinetics were determined for concentrations of antibiotic equivalent to those found in the middle ear after treatment: amoxycillin-clavulanic acid (2.5 mg l-1/0.6 mg l-1 and 2.5 mg l-1/1.2 mg l-1), cefaclor (1 mg l-1), erythromycin (0.5 mg l-1) and erythromycin/sulfisoxazole (0.2/3 mg l-1). The inoculum was of 10(6) colony-forming units (cfu) ml-1. The bacterial counts were performed after 5 h and 24 h using a spiral inoculator system. The results showed that amoxycillin-clavulanic acid had rapid bactericidal activity (< 24 h) on the tested organisms at each of the doses used (reduction < or = 3 log10 cfu ml-1) which was not observed with the other antibiotics at either 5 or 24 h. Erythromycin alone or combined with sulfisoxazole had a bacteriostatic effect on Moraxella catarrhalis and Streptococcus pneumoniae but not on Haemophilus influenzae or Staphylococcus aureus. Cefaclor had no bactericidal action under these conditions.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefaclor; Child, Preschool; Clavulanic Acids; Colony Count, Microbial; Drug Therapy, Combination; Erythromycin; Gram-Negative Bacteria; Gram-Positive Bacteria; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Staphylococcus aureus; Streptococcus pneumoniae; Sulfisoxazole

During the last three years, 79 adults suffering from acute epiglottitis have been treated in the ENT departments of the university hospital Rudolf Virchow, Berlin, 36 women (41 years of age as an average) and 43 men (average age 39 years). Acute epiglottitis developed either all of a sudden, within hours, or gradually, within days. All patients complained of dysphagia and pain in the throat; dyspnea could be observed in 20%. During examination, we could see an inflamed, thickened epiglottis with edema of the arytenoid cartilages. 55 patients reported an infection of the upper airway prior to the onset of symptoms of acute epiglottitis, epiglottic abscess developed in 11 adults. The inflammation responded satisfactorily to conservative antibiotic management (broad spectrum penicillin). Only one patient had to undergo intubation, none of the adults required tracheotomy.

Topics: Acute Disease; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Deglutition Disorders; Diagnosis, Differential; Drug Therapy, Combination; Dyspnea; Epiglottitis; Female; Humans; Laryngeal Neoplasms; Male; Middle Aged

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Animals; Clavulanic Acids; Drug Therapy, Combination; Humans; Penicillin V; Recurrence; Tonsillitis

Four days after beginning a perioperative antibiotic prophylaxis with amoxicillin and clavulanic acid a 33-year-old patient developed an acute haemorrhagic diarrhoea with cramp-like lower abdominal pain. Coloscopy revealed diffuse mucosal oedema with map-like ulcerations, increased susceptibility to trauma and submucous haemorrhages extending from the middle of the ascending to the middle of the descending colon. Granulocytic inflammation with cryptal atrophy was seen histologically. Stool cultures, including tests for Clostridium difficile toxin, were normal. All symptoms disappeared within three days of discontinuing the medication. Coloscopy after one week revealed marked improvement, after three months nothing abnormal. Acute segmental haemorrhagic penicillin-associated colitis is rare and must be distinguished from antibiotic-associated pseudomembranous colitis.

Topics: Abdominal Pain; Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Proteins; Bacterial Toxins; Clavulanic Acids; Clostridioides difficile; Colitis; Colon; Colonoscopy; Cytotoxins; Diagnosis, Differential; Diarrhea; Drug Therapy, Combination; Feces; Gastrointestinal Hemorrhage; Humans; Male

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Colitis; Drug Therapy, Combination; Gastrointestinal Hemorrhage; Humans; Male

To test the efficacy and safety of amoxycillin/clavulanate (Augmentin), 102 hospital patients with laparoscopically confirmed acute salpingitis were treated with parenteral amoxycillin/clavulanate (1.2 g qid for three days) followed by oral amoxycillin/clavulanate (two tablets of 625 mg tid for a further six days). Bacteriological samples were obtained from the cervix uteri and the pouch of Douglas. One hundred patients were assessable for clinical outcome using several variables including pain scores. Amoxycillin/clavulanate alone was effective in 95 patients (95%). Three patients (3%) responded to amoxycillin/clavulanate with marked improvement but another antibiotic was subsequently added to their treatment regimen. Treatment failed in two patients. At follow-up two weeks after hospital discharge, three patients (3.8%) had relapsed or were re-infected. Adverse drug events included one case of drug fever, one case of rash and one case of severe diarrhoea. Treatment was stopped in all three cases. Gastrointestinal reactions, mainly mild diarrhoea, were seen in 31 patients. No clinically relevant changes in haematological or clinical chemical indices were attributable to the amoxycillin/clavulanate treatment. We conclude that amoxycillin/clavulanate is a clinically effective and safe treatment for acute salpingitis.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Therapy, Combination; Erythrocyte Count; Female; Humans; Laparoscopy; Leukocyte Count; Middle Aged; Salpingitis

Acute otitis media is diagnosed commonly in the pediatric population. Numerous complications, one of which is facial palsy, may result. Facial paralysis may be the initial complaint in the child in whom acute otitis media later develops on the affected side, as was true in the case reported here. Dehiscence of the fallopian canal, physiologic canaliculi along the facial nerve to the periphery, and host resistance play an integral part in the development of facial nerve palsy from acute otitis media. The two most effective neurodiagnostic studies are the nerve excitability test and electromyography. The author also recommends daily acoustic reflex testing for denervation or reinnervation. Specific indications for conservative therapy (myringotomy, antibiotic, and decongestant) as well as for surgical intervention are discussed. The treatment in the present case was particularly conservative. It included only a broad-spectrum antibiotic, with good results.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Therapy, Combination; Electromyography; Facial Paralysis; Humans; Infant; Male; Neurologic Examination; Otitis Media

A 17-year-old schoolboy was admitted to hospital because of one-sided pelvic pain of uncertain aetiology and fever gradually rising over several days. Bacteriological analysis of blood cultures, skeletal scintigraphy and computed tomography revealed sacroiliitis caused by Salmonella cholerae-suis. Specific antibiotic treatment quickly stopped all symptoms and cured the infection. Radiologically there remained sclerosis of the sacro-iliac joint.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Arthritis, Infectious; Clavulanic Acids; Drug Combinations; Gentamicins; Humans; Male; Mefenamic Acid; Sacroiliac Joint; Salmonella; Salmonella Infections; Sulfamethoxazole; Tomography, X-Ray Computed; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

41 cases of acute salpingitis were treated: either with the combination Augmentin + Tetracycline (A + T) including 21 severe cases treated intravenously for 4 days, then per os and 10 moderate cases treated per os from the beginning-or by Augmentin alone (A) per os for 10 other moderate cases. An accurate bacteriological diagnosis was made before treatment and, in case of failure, most often by celioscopy. A Chlamydia serology was performed. Patients were seen again after 8 days (41 cases), one month (39 cases) and several months (32 cases).. A Chlamydia infection was found responsible, by culture or serology, in one out of 2 cases; only one germ was found in 14 cases, 2 germs in 21 cases and none in 7 cases. The association A + T was effective in all moderate cases at 8 and 30 days; in severe forms, there was a failure at 8 days and 4 others at 30 days or 17%. Augmentin alone per os caused 5 failures out of 10 cases at 8 days. No new failure was observed after several months in cases cured at 30 days. The association A + T may be recommended as very effective in moderate forms of acute salpingitis.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Salpingitis; Tetracycline

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Cystitis; Drug Combinations; Female; Humans; Middle Aged; Pilot Projects

The efficacy of three penicillin regimens in treating uncomplicated gonorrhoea in men was evaluated. The regimens consisted of: Augmentin 3.25 g plus probenecid 1 g orally: aqueous procaine penicillin G 4.5 MIU intramuscularly and probenecid 1 g plus one tablet of Augmentin 375 mg orally; or aqueous procaine penicillin G 4.5 MIU intramuscularly and probenecid 1 g plus two tablets of Augmentin 375 mg orally. Cure rates for infections caused by penicillinase (beta lactamase) producing Neisseria gonorrhoeae (PPNG) were 87% (20/23) for regimen 1, 97% (28/29) for regimen 2, and 95% (19/20) for regimen 3. Thus the addition of one or two tablets of Augmentin 375 mg to aqueous procaine penicillin G and probenecid cured 96% (47/49) of infections caused by PPNG strains. All three regimens were 100% effective in eradicating infections caused by non-PPNG strains. Post gonococcal urethritis occurred in 24% of cases treated with regimen 1, 14% of cases treated with regimen 2, and 15% of cases treated with regimen 3. The geometric minimum inhibitory concentrations (MIC90) of Augmentin for 72 PPNG and 162 non-PPNG isolates of N gonorrhoeae obtained before treatment were 1.98 and 0.55 mg/l, respectively. Regimen 2, besides being effective against infections caused by PPNG or non-PPNG strains, has the advantage of cost effectiveness and low toxicity. This regimen may be useful in treating gonorrhoea in areas of high prevalence of PPNG strains, such as South East Asia and Africa.

Topics: Acute Disease; Administration, Oral; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Drug Combinations; Gonorrhea; Humans; Injections, Intramuscular; Male; Penicillin G; Penicillin G Procaine; Probenecid

Forty-five patients with acute chronic bronchitis were treated with Augmentin, an amoxycillin combined with the beta-lactamase inhibitor clavulanic acid, initially by parenteral administration followed by oral treatment after 3 days lasting in the mean 7.1 days. The over-all clinical evaluation showed a cure rate of 93%. Side-effects were comparable to therapy with other amoxycillins. Bacteriological evaluation of the sputum samples demonstrated in 91% of cases an elimination of the initially isolated organism. Prior to therapy we found in 25% of the isolated strains beta-lactamase-producing and Augmentin-sensitive organisms. The parenteral formulation of Augmentin seems to be a valuable addition to the parenteral therapy of lower respiratory tract infections.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamases; Bronchitis; Clavulanic Acids; Drug Combinations; Dyspnea; Female; Humans; Infusions, Parenteral; Male; Middle Aged; Sputum

We studied 192 men with acute gonococcal urethritis, 97 of whom received two oral doses of Augmentin (amoxycillin 3 g and clavulanic acid 250 mg) separated by a four hour interval; the remaining 95 received 2 g kanamycin in a single intramuscular injection. Of the patients treated with Augmentin, 93 (95.9%) were cured, which was significantly more than the 83 (87.4%) patients treated with kanamycin. Augmentin was equally effective in the treatment of penicillinase producing Neisseria gonorrhoeae (PPNG) and non-PPNG infections, the cure rates for which were 96.6% and 95.6% respectively.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clavulanic Acids; Drug Administration Schedule; Drug Combinations; Gonorrhea; Humans; Injections, Intramuscular; Kanamycin; Male; Neisseria gonorrhoeae; Penicillinase; Urethritis