amoxicillin-potassium-clavulanate-combination and Sinusitis

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

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

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

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

Rising levels of resistance amongst the major respiratory pathogens have compromised empiric antimicrobial therapy. This, coupled with a recent lack in availability of novel classes of antibacterials, has led to a need for new approaches to combat community respiratory tract infections. Bacteriological and clinical efficacy in two trials involving patients with acute bacterial sinusitis and six trials of patients with community-acquired pneumonia has shown that the development of a pharmacokinetically enhanced formulation of amoxicillin/clavulanate (Augmentin SR, available as Augmentin XR in the USA) has allowed amoxicillin/clavulanate to retain its place in the treatment of respiratory tract infections today.

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Community-Acquired Infections; Humans; Pneumonia; Respiratory Tract Infections; Sinusitis

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

Current treatment guidelines for community-acquired respiratory tract infections no longer depend solely on the characteristics of the patient and the clinical syndrome, but on those of the offending pathogen, including presence and level of antimicrobial resistance. The most common respiratory tract pathogens known to cause acute bacterial rhinosinusitis (ABRS) and community-acquired pneumonia (CAP) include Streptococcus pneumoniae and Haemophilus influenzae. The prevalence of antimicrobial resistance, especially b-lactum and macrolide resistance, among S pneumoniae and H influenzae has increased dramatically during the past 2 decades, diminishing the activity of many older antimicrobials against resistant organisms. A pharmacokinetically enhanced formulation of amoxicillin/clavulanate has been developed to fulfill the need for an oral b-lactam antimicrobial that achieves a greater time that the serum drug concentration exceeds the minimum inhibitory concentration (T > MIC) of antimicrobials against pathogens than conventional formulations to improve activity against S pneumoniae with reduced susceptibility to penicillin. The b-lactamase inhibitor clavulanate allows for coverage of b-lactamase-producing pathogens, such as H influenzae and M catarrhalis. This article reviews the rationale for, and evolution of, oral amoxicillin clavulanate for ABRS and CAP

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Community-Acquired Infections; Drug Resistance, Bacterial; Drug Therapy, Combination; Humans; Microbial Sensitivity Tests; Pneumonia; Sinusitis

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

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

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

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

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

The efficacy and safety of a once-a-day antibiotic in the treatment of sinusitis was studied. Two randomly assigned groups were treated with either once-a-day cefixime, a third generation cephalosporin, or amoxicillin three times a day. One hundred and fourteen patients were evaluated with antral punctures, microbiologic evaluation, and radiographic studies. Cultures revealed 40% gram-negative organisms, 48% gram-positive, and 12% anaerobes. The most common bacteria were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus and viridans group streptococci. Ninety-four percent of the cefixime group were cured compared with 96% of the amoxicillin group. Staphylococcus resistance was a problem in both groups, necessitating an occasional change to amoxicillin-clavulanate potassium in the amoxicillin group. Once-a-day antibiotics offer the potential for improved compliance in the treatment of sinusitis. Cefixime offers an additional benefit of covering beta-lactamase producing strains of bacteria which are increasing in incidence and resistant to many penicillins.

Topics: Administration, Oral; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Capsules; Cefixime; Cefotaxime; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Remission Induction; Sinusitis; Time Factors

To compare the 2 long-term medical strategies in chronic rhinosinusitis without nasal polyps (CRSnNP) and to identify the role of gastroesophageal reflux disease (GERD) and Helicobacter pylori as factors of treatment failure.. Fifty-seven patients with CRSnNP were randomized into 2 therapeutic groups. The first group was treated with 4 weeks of amoxicillin/clavulanate and a short course of oral steroids. The second group received 8 weeks of clarithromycin. Sinonasal Outcome Test-20 (SNOT-20) and Lund and Mackay scores were assessed at baseline and after treatment, and GERD Health-Related Quality of Life (GERD-HRQL) questionnaire was evaluated in all patients. Patients with a GERD-HRQL score >8 received esogastroscopy and H pylori detection. Patients were followed during a 10-year period for clinical course and GERD evolution. The 10-year evolution of patients was described in terms of recurrence, medical, and surgical treatments.. Thirty-seven patients completed the study; SNOT-20 and Lund and Mackay scores similarly improved in both groups. Amoxicillin/clavulanate group had significantly more adverse reactions than the clarithromycin group (P = .03). After the therapeutic course, 35% (amoxicillin/clavulanate) and 41% (clarithromycin) of patients needed functional endoscopic sinus surgery (FESS). During the long-term follow-up, 54% (amoxicillin/clavulanate) and 40% (clarithromycin) of patients had late CRSnNP recurrence; FESS was performed in less than 15% of cases of recurrence. Gastroesophageal reflux disease complaint's severity was associated with late recurrence of CRSnNP.. Amoxicillin/clavulanate and clarithromycin would be competitive treatments for CRSnNP. Gastroesophageal reflux disease seems to be a negative factor for treatment response and recurrence.

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Clarithromycin; Drug Therapy, Combination; Female; Follow-Up Studies; Gastroesophageal Reflux; Humans; Male; Middle Aged; Patient Acuity; Rhinitis; Sino-Nasal Outcome Test; Sinusitis; Steroids

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

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

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

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

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

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

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 recommended treatment for acute bacterial rhinosinusitis in adults and children is 10 to 14 days of high doses of oral cephalosporins or amoxicillin/clavulanate.. This study compared the clinical efficacy and tolerability of cefditoren pivoxil and amoxicillin/clavulanate in children with uncomplicated acute bacterial rhinosinusitis.. This was a randomized, investigator-blinded, controlled study in pediatric patients (age 1-15 years) with clinical and radiographic signs and symptoms of acute rhinosinusitis. Patients were allocated to receive either cefditoren (8-12 mg/kg daily) or amoxicillin/clavulanate (80-90 mg/kg amoxicillin daily) for 14 days. Changes in sinus symptoms were assessed daily by patients or their parents using a quantitative symptom score (the S5 score). Rates of improvement, the primary efficacy measure, were also evaluated by the study investigators 7 and 14 days after the initial visit. Secondary outcome measures included time to improvement, adverse effects, and rates of relapse (assessed at days 21 and 28) and recurrence (assessed at day 60) of sinus symptoms. Relapse was defined as a subjective rating of lack of improvement at day 21 or 28 in a patient rated as improved on day 14, and recurrence was defined as sinus symptoms lasting for >or=10 days during the second month of follow-up in a patient rated as improved on day 28. Time to improvement was defined as the number of days between the initial visit and the time at which caregivers noted an improvement in patients' symptoms. Adverse events were monitored by parents/caregivers using a self-administered questionnaire and were also elicited by telephone contact.. The study enrolled 142 pediatric patients: 70 in the cefditoren group (42 males, 28 females; median age, 7.15 years) and 72 in the amoxicillin/clavulanate group (37 males, 35 females; median age, 6.60 years). Four patients in the cefditoren group were excluded from the study analyses (2 who were noncompliant [used <80% of the assigned medication] and 2 who developed infection at other sites). There were no significant differences in baseline medical history or signs and symptoms between the 2 groups. Rates of improvement at day 14 in the cefditoren and amoxicillin/clavulanate groups were 78.8% (52/66) and 84.7% (61/72), respectively (P = NS). There was no significant difference in the change in S5 scores between groups at day 14. The median time to improvement was 3.0 days in both groups. There were no significant differences between groups in rates of relapse (9.1% and 11.1%) or recurrence (3.0% and 5.6%) of sinus symptoms. The most common adverse event in both groups was diarrhea, occurring in 4.5% of the cefditoren group and 18.1 % of the amoxicillin/clavulanate group (P = 0.02).. In these children with acute bacterial rhinosinusitis, there were no significant differences between cefditoren and amoxicillin/clavulanate, the currently recommended treatment, in terms of rates of response, relapse, or recurrence.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Recurrence; Rhinitis; Sinusitis

Rising levels of resistance amongst the major respiratory pathogens have compromised empiric antimicrobial therapy. This, coupled with a recent lack in availability of novel classes of antibacterials, has led to a need for new approaches to combat community respiratory tract infections. Bacteriological and clinical efficacy in two trials involving patients with acute bacterial sinusitis and six trials of patients with community-acquired pneumonia has shown that the development of a pharmacokinetically enhanced formulation of amoxicillin/clavulanate (Augmentin SR, available as Augmentin XR in the USA) has allowed amoxicillin/clavulanate to retain its place in the treatment of respiratory tract infections today.

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Community-Acquired Infections; Humans; Pneumonia; Respiratory Tract Infections; Sinusitis

In children, a diagnosis of rhinosinusitis is usually made on clinical grounds. Subacute rhinosinusitis (SRS) may be the cause of persistent cough, low-grade fever, snoring, ear problems and difficult feeding in children under the age of two years.. To compare the efficacy of culture-based antibiotics and empiric amoxicillin-clavulanate (40 mg/kg/day) in treating SRS in children under the age of two years.. Randomized, controlled study.. Sixty children with persistent nasal discharge and nasal obstruction (and other related symptoms) for 30-90 days.. Group one (n = 30) received culture-based antibiotics and group two (n = 30) were treated empirically with 40 mg/kg/day of amoxicillin-clavulanate. Treatment was continued for two weeks.. At the end of the three-week follow-up period, statistically significant greater improvements in nasal obstruction (p = 0.037) and nasal discharge (p = 0.003) were seen in group one compared with group two.. culture-based antibiotics were more efficacious than empiric amoxicillin-clavulanate (40 mg/kg/day) in treating SRS in children under the age of two years.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Sinusitis; 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

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

Previous studies have suggested that aggressive treatment of sinusitis can decrease bronchial hyperresponsiveness (BHR). However, there is still too little evidence to draw this conclusion, and the concept remains controversial.. A prospective, open-label study.. University children's hospital allergy and immunology center and radiologic department.. Sixty-one children with mild asthma and allergic rhinitis participated in the study. Forty-one of these 61 children had sinusitis, and the remainder had no sinusitis. Ten matched, nonatopic, healthy children were used as a control group.. Children with chronic sinusitis were placed into two groups. One group was treated with amoxicillin-clavulanate for 6 weeks and then with nasal saline solution irrigation for 6 weeks. For the other group, the treatment order was reversed. Children without chronic sinusitis received nasal saline solution irrigation for 12 weeks.. Clinical symptoms and signs of sinusitis, FEV(1), and BHR were analyzed in the patients before and after treatment.. The clinical symptoms and signs of sinusitis, but not FEV(1), showed a significant improvement after antibiotic treatment. After aggressive treatment for sinusitis, it was found that the provocative concentration of methacholine causing a 20% fall in FEV(1) of children with mild asthma and sinusitis was significantly higher after treatment.. The results suggest that every asthmatic patient needs to carefully evaluate to determine whether the patient has concomitant sinusitis. Respiratory infections that meet criteria for sinusitis, even if they do not exacerbate asthma, should be treated. It is suggested that sinusitis should always be kept in mind as a possible inducible factor for BHR, and that aggressive treatment of chronic sinusitis is indicated when dealing with an asthmatic patient who shows an unpredictable response to appropriate treatment. Moreover, the findings of this study provide more evidence for an association between sinusitis and asthma with respect to BHR.

Topics: Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Anti-Bacterial Agents; Asthma; Bronchial Hyperreactivity; Bronchial Provocation Tests; Child; Chronic Disease; Female; Forced Expiratory Volume; Humans; Male; Prospective Studies; Rhinitis, Allergic, Perennial; Sinusitis; Statistics, Nonparametric

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

Chronic rhinosinusitis is frequently associated with asthma. A Th2 cytokine pattern has been recently reported in chronic rhinosinusitis in asthmatic children.. To evaluate the effects of treating concomitant chronic rhinosinusitis on respiratory symptoms and function and immunopathological parameters in asthmatic children.. Eighteen children with moderate asthma (age range, 5 to 12 years) poorly controlled by high doses of inhaled corticosteroids and chronic rhinosinusitis were evaluated for symptoms, spirometry, and inflammation at baseline, after treatment, and 1 month after suspension of treatment. All of the children were treated with a combination of amoxicillin and clavulanate (20 mg/kg twice daily) and fluticasone propionate aqueous nasal spray (100 microg/d) for 14 days. A short course of oral corticosteroids was also prescribed (deflazacort, 1 mg/kg daily for 2 days, 0.5 mg/kg daily for 4 days, and 0.25 mg/kg daily for 4 days). Rhinosinusal lavage for cytokine measurements and a nasal scraping for cytologic analysis were performed in all patients before and after medical treatment.. A negative endoscopy result was demonstrated in 15 children after treatment. Symptoms and respiratory function significantly improved after treatment and 1 month later; 8 children had intermittent asthma and 10 had mild asthma. A significant reduction of inflammatory cell numbers was detected in all asthmatic children. Interleukin 4 levels significantly decreased (P < 0.001), whereas interferon-y levels increased (P < 0.001).. Treatment of chronic rhinosinusitis is able to improve symptoms and respiratory function in asthmatic children, reducing inflammatory cells and reversing the cytokine pattern from a Th2 toward a Th1 profile.

Topics: Amoxicillin-Potassium Clavulanate Combination; Androstadienes; Anti-Inflammatory Agents; Asthma; Child; Child, Preschool; Drug Therapy, Combination; Endoscopy; Female; Fluticasone; Forced Expiratory Volume; Humans; Interferon-gamma; Interleukin-4; Male; Neutrophils; Pregnenediones; Rhinitis, Allergic, Perennial; Sinusitis

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

The efficacy and safety of amoxycillin/clavulanic acid (AMX/CA) (875/125 mg b.i.d. for 14 days) were compared with that of cefuroxime axetil (500 mg b.i.d. for 14 days) in a multicenter, open, parallel-group, randomized clinical trial in 206 adults with chronic or acute exacerbation of chronic sinusitis. Clinical response was similar, with 95% of AMX/CA-, and 88% of cefuroxime-treated, clinically evaluable patients cured (95% confidence interval; -0.6% to +15%). In bacteriologically evaluable patients, cure rates, defined as eradication of the original pathogen with or without re-colonization with non-pathogenic flora, were also similar, with 65% of AMX/CA- and 68% of cefuroxime-treated patients cured (95% confidence interval; -18% to +15%). However, clinical relapse was significantly higher in the cefuroxime group: 7% (7/89) of clinically evaluable patients, compared with 0% (0/98) in the AMX/CA (p=0.0049) group. A similar incidence of possible or definite adverse events related to the study drug was reported for both treatments (AMX/CA 4.4%, cefuroxime 4.3%), the most frequent being diarrhea. Four adverse events were recorded as serious or life-threatening with only one considered related to the study drug (urticaria, cefuroxime). AMX/CA 875/125 mg b.i.d. for 14 days is as effective and well tolerated as cefuroxime axetil 500 mg b.i.d. for 14 days in the treatment of chronic, or acute exacerbation of chronic sinusitis, but is associated with a significantly lower clinical relapse rate.

Topics: Administration, Oral; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Chronic Disease; Diarrhea; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Recurrence; Sinusitis; Treatment Outcome

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

The bacteriology of chronic sinusitis was studied after amoxicillin-clavulanate potassium therapy. Patients with chronic sinusitis were randomly divided into 2 groups. In the study group, 90 patients were given a 2-week course of amoxicillin-clavulanate potassium before functional endoscopic sinus surgery. In the control group, 113 patients did not take any antibiotics within 2 weeks before the surgery. Swab specimens were taken from the maxillary and ethmoid sinuses during surgery and sent for aerobic and anaerobic culture. In the study group, the culture rates of maxillary and ethmoid sinuses were 45.6% and 28.9%, respectively. In the control group, the culture rates of maxillary and ethmoid sinuses were 53.1% and 34.5%, respectively. The culture rates between the control group and the study group were not significantly different, either for the maxillary sinus or the ethmoid sinus. This showed that treatment with amoxicillin-clavulanate potassium did not change the bacteriology of chronic sinusitis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Chronic Disease; Drug Therapy, Combination; Endoscopy; Female; Humans; Male; Middle Aged; Prospective Studies; Sinusitis

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

Subacute childhood rhinosinusitis is a disorder commonly seen in children with allergic rhinitis. Antibiotics have been recommended as a major component of the treatment regime. The objective of the present study was to compare the effectiveness of a 3-day course of azithromycin and a 2-week course of amoxycillin/clavulanate in the treatment of subacute childhood rhinosinusitis.. A randomized single-blinded control study of subacute rhinosinusitis was conducted, comparing a 3-day course of azithromycin and a 2-week course of amoxycillin/clavulanate. Inclusion criteria were children aged between 5 and 16 years, duration of nasal blockage or discharge between 30 and 120 days, and abnormal sinus radiographs. All enrolled children were prescribed budesonide nasal spray (Rhinocort Aqua Nasal Spray, Astra Pharmaceuticals, Sodertalje, Sweden) as adjuvant treatment.. Forty-two children were recruited into the study and one defaulted on follow-up. Failure occurred in 6 of 20 for the azithromycin group and 5 of 21 for the amoxycillin/clavulanate group. The odds ratio was 1.46 (95%CI 0.37-5. 80, P = 0.73). No relapse occurred in azithromycin group and 5 of 21 in amoxycillin/clavulanate group. The odds ratio was 0.16 (95%CI 0. 017-1.51, P = 0.18). Both antibiotics were well tolerated, however, two children, one from each group, complained of mild transient epigastric discomfort.. This small study did not provide evidence of a difference between 14 days of amoxycillin/clavulanate and 3 days of azithromycin. Larger studies will be needed to determine which, if any, antibiotic regimen should be used in treating subacute childhood rhinosinusitis.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Single-Blind Method; Sinusitis; 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

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

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

In an open, randomized study of 60 patients with acute or recurrent sinusitis, the bacteriological and clinical efficacy of roxithromycin 150 mg bd were compared with those of po co-amoxiclav (625 mg) tds. Of 52 patients who underwent sinus puncture for isolation of causative organisms, 48 had pathogens sensitive to both antibiotics. Satisfactory clinical response was obtained in 93.1% (27/29) evaluable patients receiving roxithromycin and 88.8% (24/27) receiving co-amoxiclav. Tolerability was significantly better in the roxithromycin group, with 1/29 (3.4%) patients in this group experiencing gastrointestinal side-effects, compared with 7/27 (25.9%) patients in the co-amoxiclav group (P < 0.05). Although the study had limited power to detect differences, roxithromycin demonstrated clinical, bacteriological and overall efficacy similar to that of co-amoxiclav, but with better tolerability. Roxithromycin thus appears to be an effective and well-tolerated drug for the treatment of acute and recurrent sinusitis.

Topics: Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteroides fragilis; Bacteroides Infections; Drug Therapy, Combination; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Neisseriaceae Infections; Pneumococcal Infections; Roxithromycin; Sinusitis; Staphylococcal Infections; Streptococcus pneumoniae

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

Cefdinir is an extended-spectrum oral cephalosporin that is active against pathogens commonly seen in acute community-acquired bacterial sinusitis (ACABS), including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS. Twelve hundred twenty-nine patients entered the U.S. study, 698 with antral puncture; 569 patients entered the European study, all with antral puncture. Clinical response (cure or improvement) was determined 7 to 14 days and 3 to 5 weeks posttherapy. Microbiologic eradication rates were determined 10 to 30 days posttherapy in a subset of patients who underwent pre- and posttherapy sinus aspirate culture. Rates of adverse events and treatment discontinuations due to adverse events were examined. Cefdinir, given once or twice daily, was as effective clinically (approximately 90% cure rate) as amoxicillin-clavulanate given three times daily in the treatment of ACABS. Microbiologic eradication rates were also similar in the three groups. The major side effect was mild diarrhea, occurring in approximately 20% of each group. Cefdinir caused fewer adverse events requiring treatment discontinuation.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefdinir; Cephalosporins; Child; Clavulanic Acids; Community-Acquired Infections; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Single-Blind Method; Sinusitis; Treatment Outcome

A study of the efficacy of cefuroxime axetil was conducted for the treatment of acute sinusitis in childhood. Thirty-nine patients aged 5-14 years were given cefuroxime axetil 20 mg/kg/day divided into two doses for seven days. The diagnosis of acute sinusitis was based on history, physical examination, and radiological findings. The results of throat cultures before treatment were 17 patients with group A beta-haemolytic streptococci, seven patients with pneumococci, and two patients with Staphylococcus aureus; in the remainder of the patients only normal throat flora were isolated. In 36 patients (92%) a satisfactory improvement was reported at the end of the treatment. It was found that cefuroxime axetil was efficaceous for the treatment of sinusitis in childhood.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefaclor; Cefuroxime; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Female; Humans; Male; Pharynx; Sinusitis; Staphylococcus aureus; Streptococcus; Treatment Outcome

A total of 251 adults with chronic sinusitis were enrolled into this prospective multicentre, double-blind, double-placebo comparison of ciprofloxacin (500 mg twice daily) with amoxycillin/clavulanic acid (500 mg three times daily). The diagnosis of chronic sinusitis (persistence of clinical symptoms for at least 3 months) was confirmed by computerized tomography scan and/or sinusoscopy prior to therapy. Patients at inclusion had purulent or muco-purulent rhinorrhoea. Staphylococcus aureus (n = 45), Haemophilus influenzae (n = 35), Streptococcus pneumoniae (n = 32) and enterobacteriaceae (n = 31) were isolated from pre-treatment aspirates of the middle meatus. Treatment lasted 9 days, at the end of which nasal discharge disappeared in 71/118 (60.2%) patients of the ciprofloxacin group and 69/123 (56.1%) of those in the amoxycillin/clavulanic acid group. The clinical cure and bacteriological eradication rates were 58.6% versus 51.2% and 88.9% versus 90.5% for ciprofloxacin and amoxycillin/clavulanic acid, respectively. These differences were not significant, however, amongst patients who had a positive initial culture and who were evaluated 40 days after treatment. Ciprofloxacin recipients had a significantly higher cure rate than those treated with amoxycillin/clavulanic acid (83.3% vs. 67.6%, p = 0.043). Clinical tolerance was significantly better with ciprofloxacin (p = 0.012), essentially due to a large number of gastro-intestinal related side-effects in the amoxycillin/clavulanic acid group (n = 35). Ciprofloxacin proved to be at least as effective as amoxycillin/clavulanic acid. The superior safety profile, a twice daily dosage regimen, suggests that ciprofloxacin may be a useful therapeutic alternative for the treatment of chronic sinusitis.

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Ethmoid Sinusitis; Female; Frontal Sinusitis; Humans; Male; Maxillary Sinusitis; Middle Aged; Prospective Studies; Sinusitis

Brodimoprim is a long acting broad spectrum antibacterial agent. It is a new selective inhibitor of bacterial dihydrofolate reductase, structurally related to trimethoprim. The aim of the present study was to investigate the efficacy and tolerability of brodimoprim (10 mg/kg on the first day, 5 mg/kg/die onward) in the treatment of upper respiratory tract infections in children (age range: 2-14 years). This open group comparative study was performed either in 68 children affected by bacterial pharyngotonsillitis (37 treated with brodimoprim, 31 with erythromycin 560 mg/kg/8 hours) or in 50 patients affected by otitis media (25 treated with brodimoprim, 25 with amoxicillin/clavulanic acid 50 mg/kg/12 hours) or in 52 patients affected by acute sinusitis (25 treated with brodimoprim, 27 with amoxicillin/clavulanic acid 50 mg/kg/12 hours). All patients were clinically evaluated before admission, during the trial and 48 hours after the last dose of antibiotic. At the same time blood and secretion samples were collected for hematology/biochemistry and microbiological assays. A total of 170 subjects were treated and 141 patients demonstrated a clinical recovery/improvement following the treatment period, with approximately the same recovery rate (83%) among the groups. The bacteriological response was evaluated in 169 subjects. Eradication of pathogens was documented in 27 subjects treated with brodimoprim and 28 with erythromycin in the pharyngotonsillitis group, in 22 subjects treated with brodimoprim and 16 with amoxicillin/clavulanic acid in the otitis group and in 17 subjects treated with brodimoprim and 20 with amoxicillin/clavulanic acid in the sinusitis group. The overall eradication in brodimoprim treated patients was 77% in comparison with 76% of eradication obtained in the control groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Erythromycin; Humans; Otitis Media; Pharyngitis; Respiratory Tract Infections; Sinusitis; Tonsillitis; Trimethoprim

The diagnosis of sinusitis is difficult and there are few controlled studies of customary therapies. In particular, the possible role of topical intranasal steroid as an adjunct to antibiotic treatment has not been evaluated.. The study was a multicenter, double-blind, randomized, parallel trial in which patients aged 14 years or older were recruited from allergy practices. All patients had maxillary sinusitis documented by radiographs. Treatment consisted of amoxicillin/clavulanate potassium 500 mg combined with nasal spray of either 100 micrograms flunisolide or placebo to each nostril three times a day for 3 weeks (phase I) followed by administration of flunisolide or placebo nasal spray alone three times a day for 4 weeks (phase II).. Clinical symptoms and signs decreased significantly in both treatment groups during phase I (p < 0.01). There was a trend to greater improvement in the patients treated with flunisolide, but only the decrease in turbinate swelling/obstruction was statistically significant at the end of phase I when compared with placebo (p = 0.041). Patients' global assessment of overall effectiveness of treatment was higher for flunisolide than placebo after phase I (p = 0.007) and after phase II (p = 0.08). Maxillary sinus radiographs showed improvement in both treatment groups during phase I (p < 0.004) with somewhat greater regression of abnormal findings in patients treated with flunisolide after phase II (p = 0.066). However, 80% of radiographs were still abnormal at the end of phase I. All types of inflammatory cells were significantly decreased in nasal cytograms in patients treated with flunisolide in comparison with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of patients treated with flunisolide and 35% of those treated with placebo and tended to be more severe in the latter, although these differences were not statistically significant. Adverse events, mainly gastrointestinal symptoms and headache, were similar in both groups and more frequent in phase I than in phase II, (42 vs 15 patients); these side effects were probably due to the antibiotic.. The addition of flunisolide topical nasal spray as an adjunct to antibiotic therapy was most effective in global evaluations, tended to improve symptoms, to decrease inflammatory cells in nasal cytograms, to normalize ultrasound scans, and to aid regression of radiographic abnormalities compared with placebo spray.

Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Inflammatory Agents; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Fluocinolone Acetonide; Humans; Male; Radiography; Sinusitis

The efficacy and safety of a once-a-day antibiotic in the treatment of sinusitis was studied. Two randomly assigned groups were treated with either once-a-day cefixime, a third generation cephalosporin, or amoxicillin three times a day. One hundred and fourteen patients were evaluated with antral punctures, microbiologic evaluation, and radiographic studies. Cultures revealed 40% gram-negative organisms, 48% gram-positive, and 12% anaerobes. The most common bacteria were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus and viridans group streptococci. Ninety-four percent of the cefixime group were cured compared with 96% of the amoxicillin group. Staphylococcus resistance was a problem in both groups, necessitating an occasional change to amoxicillin-clavulanate potassium in the amoxicillin group. Once-a-day antibiotics offer the potential for improved compliance in the treatment of sinusitis. Cefixime offers an additional benefit of covering beta-lactamase producing strains of bacteria which are increasing in incidence and resistant to many penicillins.

Topics: Administration, Oral; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Capsules; Cefixime; Cefotaxime; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Remission Induction; Sinusitis; Time Factors

The need for antimicrobials in the treatment of subacute sinusitis was evaluated in 96 afebrile children who were prescribed antimicrobial (amoxicillin, amoxicillin clavulanate potassium, or trimethoprim-sulfamethoxazole) or no antimicrobial medication in addition to a decongestant and saline nasal spray for 3 weeks.. Response was determined by complete clearing of the initial radiologic abnormalities or in the case of mucosal thickening, by a significant decrease in thickness to < 6 mm within the maxillary sinuses associated with improvement of the clinical signs and symptoms of sinusitis. If there was evidence of partial clearing by radiograph, the same therapy was continued for another 3 weeks. Nonresponders demonstrated no change or worsening of clinical and radiologic findings.. Sixty-seven of the 96 subjects (70%) responded: 58 (87%) in 3 weeks and 9 (13%) in 6 weeks. Fifty-five of the responders were in the antimicrobial treatment group, and 12 were prescribed no antimicrobial medication. Twenty-nine of the 96 subjects (30%) did not respond to treatment; 22 received an antimicrobial and seven received no antimicrobial medication.. The number of responders and nonresponders was similar in the antimicrobial- and nonantimicrobial-treated groups (p = NS), and no single antimicrobial medication demonstrated greater treatment effectiveness.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Paranasal Sinuses; Radiography; Sinusitis; Trimethoprim, Sulfamethoxazole Drug Combination

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

Efficacy and safety of Augmentin were evaluated in 79 patients, 64 adults and 15 children, treated for sinusitis during a multicentric hospital trial. Pre-treatment meatal pus samples were examined for bacteriology: 37 of 39 strains (95%) isolated from adults were sensitive to Augmentin, and two beta-lactamase producing Haemophilus strains sensitive to Augmentin were isolated from the children. Adult dosage was usually 2 g per day as two divided doses over 8 to 10 days. Recovery was obtained at end of treatment in 92% of cases, side effects being reported in 56 patients, including 8 with benign digestive disorders. Usual dosage in children was 25 to 50 mg/kg/d over 8 to 10 days and treatment was effective in 13 cases. One child developed a skin rash, and there was no report of digestive disturbance.

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Drug Therapy, Combination; Female; Humans; Infant; Male; Middle Aged; Sinusitis

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

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

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

There is limited evidence supporting the usage of prophylactic antibiotics in the setting of nasal packing for epistaxis. It is unclear what current antiobiotic usage patterns are by otolaryngologists.. Characterize the antibiotic prescribing practices employed by otolaryngologists in the management of epistaxis patients treated with packing as well as the underlying rationale. Explore the impact of experience, geography, and academic affiliation on treatment decisions.. An anonymous survey of antibiotic prescribing patterns for patients with epistaxis requiring nasal packing was distributed to all physician members of the American Rhinologic Society. Responses to each question were descriptively summarized including 95% confidence intervals and were linked to demographics using Fisher's exact tests.. Antibiotic use in patients with epistaxis controlled with nondissolvable packing is common. Treatment patterns are influenced by geography, years in practice, and practice type.. 4.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Epistaxis; Humans; 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

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

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

Microbial biofilms have been implicated in the pathogenesis of chronic rhinosinusitis with nasal polyposis (CRSwNP). The aim of our study was to evaluate in vitro effects of amoxicillin-clavulanic acid and levofloxacin on biofilm formation by bacterial species isolated from sinus tissue in patients with CRSwNP.. The sinus mucosal specimens were harvested from the upper parts and roof of ethmoid cavity of 48 patients with CRSwNP. Each sample was washed thoroughly in three separate beakers of sterile saline to remove any planktonic bacteria and further subjected to microbiology analysis. The biofilm-forming capacity of isolated strains was detected by microtiter-plate method and the effects of subinhibitory (1/2× to 1/16× MIC) and suprainhibitory concentrations (4, 8, 16, 32, and 64 µg/ml) of amoxicillin-clavulanic acid and levofloxacin on biofilm production were investigated.. Bacterial strains were isolated in 42 (87.5%) patients: one microorganism in 80.9% and two microorganisms in 19.1% of patients. The most prevalent bacteria in CRSwNP biofilms were Staphylococcus epidermidis (34%) and S. aureus (28%) followed by S. haemolyticus (12%), Pseudomonas aeruginosa (8%), Moraxella catarrhalis (6%), Streptococcus pneumoniae (6%), and other staphylococci (6%). Subinhibitory concentrations of amoxicillin-clavulanic acid and levofloxacin significantly reduced biofilm formation (p < 0.01 and p < 0.05, respectively), with better efficacy of amoxicillin-clavulanic acid (1/2-1/8× MIC) on staphylococci and levofloxacin (1/2- 1/4× MIC) on M. catarrhalis and P. aeruginosa biofilm formation. Suprainhibitory concentrations of both tested antibiotics (4-64 µg/ml) significantly eradicated mature biofilms of staphylococci (p < 0.01). The effect of levofloxacin on eradication of staphylococcal biofilms was more noticeable, compared to the effect of amoxicillin-clavulanic acid (p < 0.01). Suprainhibitory concentrations of both tested antibiotics had no effect on eradication of previously formed M. catarrhalis and P. aeruginosa biofilms (p > 0.05).. The amoxicillin-clavulanic acid and levofloxacin are shown to be potent antibiofilm agents in patients with CRSwNP. The effects of tested compounds depend on bacterial species and the volume of formed biofilm.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; beta-Lactamase Inhibitors; Biofilms; Chronic Disease; Female; Humans; Levofloxacin; Male; Microbial Sensitivity Tests; Middle Aged; Nasal Polyps; Rhinitis; Sinusitis

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Chronic Disease; Endoscopy; Eosinophilia; Female; Humans; Male; Middle Aged; Prospective Studies; Rhinitis; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome

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

A superior subperiosteal orbital abscess (SSPOA) is a collection of purulent material between the periorbit and the superior bony orbital wall, and is typically a complication of frontal sinusitis. SSPOA is characteristically managed by classic external surgical drainage. The aim of our study was to assess the role of surgical intervention in SSPOA. A retrospective medical chart review of patients diagnosed with SSPOA secondary to rhinosinusitis between the year 2005 and 2013 was conducted. Collected data included age, gender, co-morbidity, clinical presentation, prior antibiotic management, CT scans, surgical approach, outcome and complications. Six patients were included in our study, three males and three females with a mean age of 22.8 (range 9-58). Two patients were treated with amoxicillin clavulanic acid for 3 days prior to admission. Only the youngest patient with the smallest abscess responded successfully to conservative treatment, while the rest were managed surgically: three patients were treated successfully by the endonasal endoscopic approach and two patients were treated by utilizing the combined endonasal endoscopic and external approach. In patients who underwent the combined approach, the abscess was located in a more antero-lateral position than those treated endonasal endoscopically only. The location of a SSPOA dictates the surgical approach. The most antero-lateral SSPOAs should be drained by the combined approach, while more posterior abscesses should be approached endoscopically. Furthermore, a small SSPOA is first to be reported to resolve with conservative treatment. Level 4 (case series).

Topics: Abscess; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; beta-Lactamase Inhibitors; Child; Drainage; Endoscopy; Female; Humans; Male; Middle Aged; Orbital Diseases; Retrospective Studies; Rhinitis; Sinusitis; Young Adult

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

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

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

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

Though general antibiotic consumption data is available, information on the actual patterns of prescribing antibiotics locally is difficult to obtain. An easy to use methodology was designed to assess ambulatory management of infections by Latvian general practitioners (GPs).. GPs were asked to record data in a patient data collection form for every patient that received antibiotics. Study period - (7 days) one week in November, 2008. Data recorded included the following details: an antibiotic, the prescribed dose, dosing interval, route of administration combined with the demographic factors of the patient and clinical diagnosis based on a pre-defined list.. Two hundred forty eight forms out of the 600 (41%) were returned by post. Antibiotics were prescribed in 6.4% (1711/26803) of outpatient consultations. In total, 1763 antibiotics were prescribed during the study period. Ninety seven percent of the patients received monotherapy and only 47 (2.7%) patients were prescribed two antibiotics. The most commonly prescribed antibiotics were amoxicillin (33.9% of prescribed), amoxicillin/clavulanate (18,7%) and clarithromycin (7.6%). The most commonly treated indications were pharyngitis (29.8%), acute bronchitis (25.3%) and rhinosinusitis (10.2%). Pneumonia was mostly treated with amoxicillin/clavulanate (25,7%), amoxicillin (15.7%) and clarithromycin (19.3%).. Methodology employed provided useful additional information on ambulatory practice of prescribing antibiotics and could be used in further assessment studies. Educational interventions should be focused on treatment of acute pharyngitis and bronchitis in children and unnecessary use of quinolones in adults for uncomplicated urinary tract infection.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bronchitis; Child; Child, Preschool; Clarithromycin; Drug Prescriptions; Female; General Practice; Humans; Infant; Latvia; Male; Middle Aged; Pharyngitis; Pneumonia; Practice Patterns, Physicians'; Sinusitis; Surveys and Questionnaires; Urinary Tract Infections; Young Adult

Topics: Adult; Algorithms; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Humans; Rhinitis; Sinusitis

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

This prospective, randomized, and controlled study examined the effects of tumor necrosis factor soluble receptor type I (sTNFRI, a TNF-α antagonist) on experimentally induced rhinosinusitis in rats. The experimental groups received an instillation of lipopolysaccharide (LPS) plus an intramuscular injection of amoxicillin/clavulanate (antibiotic group), an instillation of sTNFRI (sTNFRI group), an instillation of sTNFRI and an injection of amoxicillin/clavulanate (sTNFRI/antibiotic group), or no additional treatment (LPS group). Histopathological changes were determined using hematoxylin-eosin and periodic acid-Schiff (PAS) staining. Leakage of exudate was determined using fluorescence microscopy. Vascular permeability was measured using the Evans blue dye technique. Expression of MUC5AC was measured using reverse transcriptase PCR. The sTNFRI, antibiotic, and sTNFRI/antibiotic groups had significantly less capillary permeability, mucosal edema, PAS staining, and expression of MUC5AC than the LPS group. There were no differences in capillary permeability, mucosal edema, PAS staining, and MUC5AC expression between the sTNFRI and sTNFRI/antibiotic groups. The antibiotic group had PAS staining similar to that of the sTNFRI and sTNFRI/antibiotic groups but had a greater increase in capillary permeability, mucosal edema, and MUC5AC expression. This study shows that sTNFRI reduces inflammatory activity and mucus hypersecretion in LPS-induced rhinosinusitis in rats.

Topics: Administration, Intranasal; Amoxicillin-Potassium Clavulanate Combination; Animals; Capillary Permeability; Disease Models, Animal; Histocytochemistry; Lipopolysaccharides; Microscopy, Fluorescence; Mucin 5AC; Nasal Mucosa; Prospective Studies; Random Allocation; Rats; Rats, Sprague-Dawley; Receptors, Tumor Necrosis Factor, Type I; Rhinitis; Sinusitis; Tumor Necrosis Factor-alpha

Sinusitis is a rare cause of optic neuritis in children. This case illustrates bilateral optic neuritis in a 9-year-old child caused by pansinusitis. It demands an accurate diagnosis with a prompt management. A proper treatment of sinusitis is essential to prevent this complication.

Topics: Amoxicillin-Potassium Clavulanate Combination; Blood Sedimentation; Child; Drug Therapy, Combination; Functional Laterality; Glucocorticoids; Humans; Leukocyte Count; Magnetic Resonance Imaging; Male; Optic Neuritis; Sinusitis; Tomography, X-Ray Computed; Vision Disorders; Visual Acuity

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Burkholderia cepacia complex; Burkholderia Infections; Cefazolin; Ceftibuten; Cephalosporins; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Nasal Polyps; Ofloxacin; Prospective Studies; Sinusitis; Sulbactam

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drainage; Ethmoid Sinus; Female; Headache; Humans; Magnetic Resonance Imaging; Sinusitis; Sphenoid Sinus; Tomography, X-Ray Computed

We sought to determine whether the bacteria in complicated rhinosinusitis were the typical acute rhinosinusitis triad of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. We also compared the difference in yield between infection sites and blood cultures.. We performed a retrospective review of all patients who had required surgical intervention for rhinosinusitis complications over 7 years at a tertiary care pediatric hospital.. There were a total of 28 patients during the review period. Twenty-five organisms were isolated from 21 patients, of which Streptococcus viridans formed 44% of the isolates (11 of the 25). The typical triad of bacteria only formed 20% of the isolates (5 of the 25), and none of these bacteria were found in the group with intracranial complications. Infection site cultures had a superior yield compared to blood cultures (p < .001). Ninety-six percent of the bacteria were sensitive to a combination of amoxicillin-clavulanate and cloxacillin.. In distinction to the typical bacteria of acute rhinosinusitis, S. viridans is the leading cause of rhinosinusitis complications. It is not merely a commensal organism of the upper respiratory tract.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteremia; Child; Child, Preschool; Cloxacillin; Female; Humans; Male; Retrospective Studies; Rhinitis; Sinusitis; Viridans Streptococci

A common problem for the clinician in an outpatient clinic is to distinguish a drug eruption from a viral exanthem in a child. The aim of this study was to describe the common drug eruptions seen in children with ENT infections, suggesting an approach to this problem.. We studied the cases of ENT patients aged 15-years-old and below, with the clinical diagnosis of cutaneous adverse reactions. Main variables in the assessment of drug etiology in skin eruptions were previous experience with the drug in the general population, alternative explanation for the eruption, timing between the ingestion of the drug and the appearance of the lesions, drug levels or evidence of overdose or long-acting drug, subsequent progression of the eruption and reactions to dechallenge and rechallenge.. A total of 47 children were examined during a period of 11 months. The indications for drug prescribed were tonsillitis, pharyngitis, rhinitis, otitis and sinusitis. The most usually implicated drugs were amoxycillin-clavulanic acid, cephalosporin, clindamycin, erythromycin, clarithromycin and paracetamol. The main clinical patterns of the eruptions seen were urticaria, maculopapular rash, fixed drug eruption and erythema multiforme.. Careful clinical examination, detailed history, knowledge of the numerous clinical patterns of the eruptions and the drugs specific reaction rates, as well as oral drug rechallenge, RAST and patch tests if indicated, are essential factors in the management of patients with drug eruptions.

Topics: Acetaminophen; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Cephalosporins; Child; Child, Preschool; Clarithromycin; Clindamycin; Diagnosis, Differential; Drug Eruptions; Erythromycin; Female; Humans; Infant; Infections; Male; Otitis; Otorhinolaryngologic Diseases; Pharyngitis; Prospective Studies; Rhinitis; Risk Factors; Sinusitis; Stomatognathic Diseases; Tonsillitis

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

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Female; Humans; Male; Middle Aged; Pneumococcal Infections; Sinusitis; Treatment Outcome

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

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

A Th2 cytokine pattern has recently been reported both in allergic and nonallergic chronic rhinosinusitis in asthmatic children. The aim of the study was to evaluate the cytokine pattern in chronic rhinosinusitis in allergic and nonallergic asthmatic children before and after medical treatment. Thirty asthmatic children were evaluated, 18 males and 12 females (mean age 9.1 years). Sixteen were allergic and 14 were nonallergic. All children were asthmatic and suffered from chronic rhinosinusitis, whose diagnosis was confirmed by endoscopy. All of them were treated with amoxicilline-clavulanate (20 mg/kg b.i.d.) and fluticasone propionate aqueous nasal spray (100 microg daily) for 14 days; a short course of oral corticosteroid was also prescribed (deflazacort 1 mg/kg daily for 2 days, 0.5 mg/kg daily for 4 days and 0.25 mg/kg daily for 4 days). Rhinosinusal lavage and nasal cytology were performed in all subjects before and after medical treatment. IL4 and IFNgamma were measured by immunoassay and inflammatory cells were counted by conventional staining. Thirteen allergic children and 12 nonallergic children showed a negative endoscopy after the treatment. Allergic subjects showed a significant decrease of IL4 (p = 0.0002) and a significant increase of IFNgamma (p = 0.03) after the treatment. Nonallergic children showed a significant decrease of IL4 (p = 0.0007) and a nonsignificant increase of IFNgamma. A significant reduction of the inflammatory infiltrate was detected in all asthmatic children (p < 0.05). This study confirms a Th2 polarization in chronic rhinosinusitis both in allergic and nonallergic asthmatic children. Moreover, the medical treatment of chronic rhinosinusitis reversed the cytokine pattern from a Th2 towards a Th1 profile both in allergic and nonallergic children.

Topics: Amoxicillin-Potassium Clavulanate Combination; Androstadienes; Anti-Allergic Agents; Anti-Bacterial Agents; Asthma; Child; Child, Preschool; Chronic Disease; Endoscopy; Female; Fluticasone; Humans; Interferon-gamma; Interleukin-4; Male; Sinusitis; Th2 Cells; Treatment Outcome

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

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

Amoxicillin/clavulanate in chronic rhinosinusitis: tissue and serum distribution.. The aim of the present study is to determine the concentrations of coamoxiclav in the sinusal mucosa of patients undergoing surgery for chronic sinusitis in comparison to serum levels after single oral administration.. 24 patients affected by chronic sinusitis, undergoing sinus surgery, were divided into three groups receiving an oral dose of 1 g of coamoxiclav (875 mg amoxicillin, 125 g of clavulanic acid, 7:1 ratio) at 2 h (first group), 4 h (second group) and 6 h (third group) before surgery. The mean concentration of amoxicillin and clavulanic acid were determined biologically in serum and in tissues.. The highest concentrations of coamoxiclav both in serum and tissues were observed in the group which received the antibiotic 2 hours before surgery. However the tissue levels of both amoxicillin and clavulanic acid in the time period within 2-6 h after administration were higher than the Minimum Inhibitory Concentration (MIC) for the most frequent causative pathogens of sinus bacterial infections.. Since penicillins need to maintain concentrations above the MIC for at least 40 to 60% of the interval time between administrations to be potentially effective, the Authors concluded that since both amoxicillin and clavulanic acid spread well in the ENT tissues, 1 g twice a day of the combination seems to be clinically effective even in patients suffering from acute episodes of chronic rhinosinusitis.

Topics: Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Chronic Disease; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Paranasal Sinuses; Rhinitis; Sinusitis; Time Factors

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

By an agar dilution method, the antimicrobial susceptibilities of antral sinus puncture isolates were studied. Pneumococci were generally susceptible to amoxicillin, azithromycin, and clarithromycin, but 17% of pneumococcal isolates were resistant to cefuroxime. Haemophilus influenzae isolates were resistant to amoxicillin and clarithromycin. beta-Lactamase production occurred in 69% of Prevotella species. One-third of Peptostreptococcus magnus isolates were resistant to azithromycin and clarithromycin. Cefuroxime had limited activity against Prevotella species and P. magnus. Levofloxacin was active against most isolates except peptostreptococci. Amoxicillin-clavulanate was active against all isolates, with the MIC at which 90% of the isolates were inhibited being < or = 1 microgram/ml.

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Bacteria, Aerobic; Bacteria, Anaerobic; Colony Count, Microbial; Drug Therapy, Combination; Humans; Sinusitis

The exact incidence of orbital complications due to sinusitis in children is unknown. However, a medial subperiosteal orbital abscess is the most common serious complication to occur. Surgical intervention is mandatory whenever antibiotic treatment fails. Most authors prefer open surgical procedures such as external ethmoidectomy, while others recommend transnasal endoscopic drainage as the first attempt at sinus decompression. Five out of 12 children with proven subperiosteal orbital abscess and sinusitis on computed tomographic scans failed antibiotic treatment and required surgical drainage. Transnasal endoscopic drainage of the abscess was performed on four patients, while one child underwent external ethmoidectomy. Our experience with endoscopic surgery in these four cases is discussed, along with a brief review of the advantage of this procedure over external surgery.

Topics: Abscess; Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Cefuroxime; Cephalosporins; Child; Child, Preschool; Drainage; Drug Therapy, Combination; Endoscopy; Ethmoid Bone; Ethmoid Sinusitis; Female; Frontal Sinusitis; Humans; Male; Maxillary Sinusitis; Nose; Orbital Diseases; Periosteum; Sinusitis; Tomography, X-Ray Computed; Treatment Failure

A 55-year-old man was admitted because of cholestatic jaundice. Extrahepatic obstruction and viral causes were excluded. A diagnosis of liver damage due to the combination preparation amoxicillin and clavulanic acid (Augmentin) was made. The patient had an uneventful recovery. It is pointed out that in case of cholestatic jaundice drug-induced cholestasis should be suspected early in the course. History taking is an important tool. If a suspected drug is found other causes of the disease can be excluded with simple tests.

Topics: Amoxicillin-Potassium Clavulanate Combination; Cholestasis; Humans; Male; Middle Aged; Sinusitis; Treatment Outcome

The aim of this work was to study the bacterial flora of purulent secretions during chronic rhinosinusitis. We studied a total of 533 patients divided into two groups. The control population consisted of 139 adults (> 16 years) of both sexes seen in the community or hospitalized for less than 72 hours for non-rhinological conditions. The rhinosinusitis group consisted of 394 patients referred to the ENT clinic with chronic rhinosinusitis. All the patients with rhinosinusitis had had a post-nasal discharge for at least three months, associated with purulent or mucopurulent secretions originating from the involved sinus cavity. All samples were obtained endonasally under endoscopic guidance from the sinus ostium or from the sinus cavity during surgery. Cultures were positive in 81.3 per cent of the control subjects and 83.1 per cent of the patients with rhinosinusitis. Corynebacteria, coagulase-negative staphylococci, propionibacteria and peptostreptococci were the main commensal organisms, while Haemophilus influenzae, streptococci, Streptococcus pneumoniae, Prevotella spp and Fusobacterium spp were probable causative pathogens. Anaerobes were isolated from approximately 25 per cent of the patients in the rhinosinusitis group. Betalactamase producers represented 27.5 per cent of H. influenzae and 28 per cent of Prevotella spp isolates. Diminished susceptibility to penicillin was found in 13 per cent of S. pneumoniae isolates. The amoxycillin-clavulanate combination was the most active oral antibiotic tested against the pathogenic species in vitro.

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Bacteria, Aerobic; Bacteria, Anaerobic; Chronic Disease; Drug Resistance, Microbial; Drug Therapy, Combination; Endoscopy; Female; Humans; Leukocyte Count; Male; Middle Aged; Paranasal Sinuses; Sinusitis; Specimen Handling

This 70-year-old man experienced an episode of cholestatic hepatitis most likely due to an immunologically mediated reaction to amoxicillin-clavulanate. The episode occurred after cessation of the drug combination. Duration of illness was 16 weeks, and the patient recovered completely.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Chemical and Drug Induced Liver Injury; Cholestasis, Intrahepatic; Clavulanic Acids; Drug Therapy, Combination; Humans; Liver Function Tests; Male; Sinusitis

We treated a 5-year-old girl and a 6-year-old boy with acquired Brown's syndrome associated with pansinusitis. In both patients, the diagnosis was established roentgenographically, and the patients were treated with oral antibiotics. Systemic corticosteroids were used in one case, although their clinical value was uncertain. Patients presenting with acute-onset Brown's syndrome of undetermined cause should undergo computed imaging of the orbits and paranasal sinuses.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Diplopia; Drug Therapy, Combination; Eye Diseases; Female; Humans; Male; Oculomotor Muscles; Prednisone; Sinusitis; Syndrome; Tomography, X-Ray Computed

Topics: Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Otitis; Pharyngitis; Rhinitis; Sinusitis; Tonsillitis