zithromax and Acute-Disease

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

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

Acute wheezing episodes are frequent in young children and are associated with high morbidity and healthcare utilization. The role of respiratory viruses in triggering acute wheezing is well known. There is also accumulating evidence that airway bacteria, either alone or as part of bacteria-virus interaction, are important determinants of acute asthma exacerbations. Targeting airway bacteria with antibiotics to reduce the severity of acute wheezing episodes and prevent recurrent wheezing among preschool children has been recently evaluated in three randomized, double-blind, placebo-controlled trials. The results of these studies are controversial. An interventional approach with azithromycin in young children during acute wheezing episodes cannot be generically incorporated into clinical practice, due to the potential consequences of widespread use of antibiotics in such a common clinical setting. This intervention may be reserved for children with really severe, recurrent wheezing episodes. Future research should focus on risk factors that facilitate acquisition of bacterial airway infection in young children and better understanding how virus and bacteria interact with each other during wheezing attacks. Identifying objective biomarkers that may direct the treatment to specific groups of children may represent a significant step forward in the clinical approach of acute wheezing.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Child, Preschool; Clinical Trials as Topic; Dysbiosis; Humans; Inflammation; Microbial Interactions; Microbiota; Patient Selection; Recurrence; Respiratory Sounds; Respiratory Tract Infections; Severity of Illness Index; Virus Diseases

Topics: Acute Disease; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Azithromycin; Humans; Magnesium Sulfate; Nebulizers and Vaporizers

Diarrhoea is one of the most commonly occurring diseases. This article presents a review of the current state of the treatment of acute infectious diarrhoea, as well as of the most important pathogens. The general principles of the therapy of diarrhoea are exemplified, followed by a description of the targeted antimicrobial therapy of the most important bacterial gastrointestinal infections, including salmonellosis, shigellosis and Campylobacter infections, as well as infections with pathogenic Escherichia coli strains, yersiniosis and cholera. Diarrhoea caused by toxigenic Clostridium difficile strains has increased in incidence and in severity. These infections will therefore be described in detail, including important new aspects of treatment. Symptomatic therapy is still the most important component of the treatment of infectious diarrhoea. However, empirical antibiotic therapy should be considered for severely ill patients with a high frequency of stools, fever, bloody diarrhoea, underlying immune deficiency, advanced age or significant comorbidities. Increasing resistance, in particular against fluoroquinolones, must be taken into consideration. Therapy with motility inhibitors is not recommended for Shiga toxin-producing Escherichia coli (STEC) infections, Clostridium difficile infections (CDI), and severe colitis. The macrocyclic antibiotic fidaxomicin can reduce the rate of recurrent disease in CDI. Furthermore, evidence for the benefits of faecal microbiota transplantation as a treatment option for multiple recurrences of CDI is increasing. In conclusion, the treatment of acute diarrhoea is still primarily supportive. General empirical antibiotic therapy for acute diarrhoea is not evidence-based.

Topics: Acute Disease; Aminoglycosides; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Campylobacter Infections; Cholera; Ciprofloxacin; Diarrhea; Dysbiosis; Dysentery, Bacillary; Enterocolitis, Pseudomembranous; Escherichia coli Infections; Fidaxomicin; Gastroenteritis; Humans; Rifamycins; Rifaximin; Salmonella Infections; Shiga-Toxigenic Escherichia coli; Yersinia Infections

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

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

The objective of the present publication was to report the result of the evaluation of the clinical effectiveness of azithromycin (Sumamed) antimicrobial therapy used for the treatment of bacterial acute rhinsinusitis (ARS) in the patients presenting with concomitant pathology of the respiratory and cardiovascular systems. Dynamics of the reversal of the clinical symptoms of bacterial ARS in the patients of the study group is described. Neither adverse side effects nor complications in response to the treatment were documented. 98.6% of the patients recovered from the disease within 7 days after the onset of the treatment. It is concluded that antimicrobial therapy with the use of azithromycin (Sumamed) based at the outpatient settings provides a highly efficient tool for the treatment of the patients presenting with concomitant pathology of the respiratory and cardiovascular systems.. Цель работы - представить результаты клинических наблюдений лечения азитромицином (Сумамед) бактериального острого риносинусита (ОРС) у пациентов с сопутствующей патологией дыхательной и сердечно-сосудистой систем. Описана обратная динамика симптомов бактериального ОРС в наблюдаемой группе. Неблагоприятных побочных эффектов лечения и осложнений за период лечения не выявлено. В 98,6% случаев на 7-е сутки констатировано выздоровление. Вывод: терапия бактериального ОРС противомикробным препаратом азитромицин (Сумамед) в амбулаторном режиме у лиц с сопутствующей патологией дыхательной и сердечно-сосудистой систем продемонстрировала высокую клиническую эффективность.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Cardiovascular Diseases; Humans; Respiratory Tract Diseases; Sinusitis; Treatment Outcome

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Forced Expiratory Volume; Humans; Macrolides; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Respiratory Function Tests

The standard duration of treatment for children with acute group A beta hemolytic streptococcus (GABHS) pharyngitis with oral penicillin is 10 days. Shorter duration antibiotics may have comparable efficacy.. To summarize the evidence regarding the efficacy of two to six days of newer oral antibiotics (short duration) compared to 10 days of oral penicillin (standard duration) in treating children with acute GABHS pharyngitis.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2012, Issue 3) which contains the Cochrane Acute Respiratory Infections Group's Specialized Register, MEDLINE (January 1966 to March week 3, 2012) and EMBASE (January 1990 to April 2012).. Randomized controlled trials (RCTs) comparing short duration oral antibiotics to standard duration oral penicillin in children aged 1 to 18 years with acute GABHS pharyngitis.. Two review authors scanned the titles and abstracts of retrieved citations and applied the inclusion criteria. We retrieved included studies in full, and extracted data. Two review authors independently assessed trial quality.. We included 20 studies with 13,102 cases of acute GABHS pharyngitis. The updated search did not identify any new eligible studies; the majority of studies were at high risk of bias. However, the majority of the results were consistent. Compared to standard duration treatment, the short duration treatment studies had shorter periods of fever (mean difference (MD) -0.30 days, 95% confidence interval (CI) -0.45 to -0.14) and throat soreness (MD -0.50 days, 95% CI -0.78 to -0.22); lower risk of early clinical treatment failure (odds ratio (OR) 0.80, 95% CI 0.67 to 0.94); no significant difference in early bacteriological treatment failure (OR 1.08, 95% CI 0.97 to 1.20) or late clinical recurrence (OR 0.95, 95% CI 0.83 to 1.08). However, the overall risk of late bacteriological recurrence was worse in the short duration treatment studies (OR 1.31, 95% CI 1.16 to 1.48), although no significant differences were found when studies of low dose azithromycin (10 mg/kg) were eliminated (OR 1.06, 95% CI 0.92 to 1.22). Three studies reported long duration complications. Out of 8135 cases of acute GABHS pharyngitis, only six cases in the short duration treatment versus eight in the standard duration treatment developed long-term complications in the form of glomerulonephritis and acute rheumatic fever, with no statistically significant difference (OR 0.53, 95% CI 0.17 to 1.64).. Three to six days of oral antibiotics had comparable efficacy compared to the standard duration 10-day course of oral penicillin in treating children with acute GABHS pharyngitis. . In areas where the prevalence of rheumatic heart disease is still high, our results must be interpreted with caution.

Topics: Acute Disease; Administration, Oral; Adolescent; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Drug Administration Schedule; Humans; Infant; Penicillins; Pharyngitis; Randomized Controlled Trials as Topic; Recurrence; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

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

To determine the efficacy of a short course of antibiotics (<4 days) in comparison to a longer course (>4 days) for the treatment of acute otitis media in children.. Electronic databases, hand search of reviews, bibliographies of books, abstracts and proceedings of international conferences.. Randomized controlled trials of the empiric treatment of acute otitis media comparing antibiotic regimens of <4 days versus > 4 days in children between four weeks to eighteen years of age were included. The trials were grouped by pharmacokinetic behavior of short-course antibiotics into short-acting antibiotics, parenteral ceftriaxone, and long-acting azithromycin.. We reviewed 35 trials, which provided 38 analytic components. Overall, there was no evidence of an increased risk of treatment failure until one month with a short-course of antibiotics (RR=1.06, 95% CI 0.95 to 1.17, P=0.298). Use of short-acting oral antibiotic in short-course was associated with a significantly increased risk of treatment failure (RR=2.27, 95% CI: 1.04 to 4.99). There was a slightly increased risk of treatment failure with parenteral ceftriaxone (RR=1.13, 95% CI 0.99 to 1.30). The risk of adverse effects was significantly lower with short-course regimens (RR=0.58, 95% CI: 0.48 to 0.70).. There is no evidence of an increased risk of treatment failure with short course of antibiotics for acute otitis media. Among the short course regimens, azithromycin use was associated with a lower risk of treatment failure while short acting oral antibiotics and parenteral ceftriaxone may be associated with a higher risk of treatment failure.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Child; Child, Preschool; Drug Administration Schedule; Humans; Infant; Otitis Media; Randomized Controlled Trials as Topic; Treatment Outcome

Acute otitis media (AOM) is a common illness during childhood, for which antibiotics are frequently prescribed.. To determine the effectiveness of a short course of antibiotics (less than seven days) in comparison to a long course of antibiotics (seven days or greater) for the treatment of AOM in children.. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 4) which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, CINAHL, BIOSIS Previews, OCLC Papers First and Proceedings First, Proquest Dissertations and Theses (inception to November 2009); International Pharmaceutical Abstracts, the NLM Gateway, ClinicalTrials.gov and Current Controlled Trials (inception to August 2008).. Trials were included if they met the following criteria: participants aged one month to 18 years; clinical diagnosis of ear infection; no previous antimicrobial therapy; and randomisation to treatment with less than seven days versus seven days or more of antibiotics.. The primary outcome of treatment failure was defined as the absence of clinical resolution, relapse or recurrence of AOM during one month following initiation of therapy. Treatment outcomes were extracted from individual studies and combined in the form of a summary odds ratio (OR). A summary OR of 1.0 indicates that the treatment failure rate following less than seven days of antibiotic treatment was similar to the failure rate following seven days or more of treatment.. This update included 49 trials containing 12,045 participants. Risk of treatment failure was higher with short courses of antibiotics (OR 1.34, 95% CI 1.15 to 1.55) at one month after initiation of therapy (21% failure with short-course treatment and 18% with long-course; absolute difference of 3% between groups). There were no differences found when examining treatment with ceftriaxone for less than seven days (30% failure in those receiving ceftriaxone and 27% in short-acting antibiotics administered for seven days or more) or azithromycin for less than seven days (18% failure in both those receiving azithromycin and short-acting antibiotics administered for seven days or more) with respect to risk of treatment failure at one month or less. Significant reductions in gastrointestinal adverse events were observed for treatment with short-acting antibiotics and azithromycin.. Clinicians need to evaluate whether the minimal short-term benefit from longer treatment of antibiotics is worth exposing children to a longer course of antibiotics.

Topics: Acute Disease; Age Factors; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Child; Drug Administration Schedule; Humans; Otitis Media; Time Factors

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Bronchitis; Child; Delayed-Action Preparations; Diarrhea; Female; Humans; Laryngitis; Male; Middle Aged; Patient Satisfaction; Surveys and Questionnaires; Time Factors; Young Adult

Topics: Acute Disease; Administration, Oral; Azithromycin; Chemistry, Pharmaceutical; Delayed-Action Preparations; Dosage Forms; Drug Delivery Systems; Drug Interactions; Drug Resistance, Bacterial; Haemophilus influenzae; Humans; Microspheres; Patient Satisfaction; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Streptococcus pneumoniae

Acute rheumatic fever and rheumatic chronic valvular heart disease is an important preventable cause of morbidity and mortality in suburban and rural India. Its diagnosis is based on clinical criteria. These criteria need verification and revision in the Indian context. Furthermore, there are glaring differences in management protocols available in literature. These facts prompted Indian Academy of Pediatrics to review the management of rheumatic fever.. Management of Rheumatic fever was reviewed and recommendation was formulated at national consultative meeting on 20th May 2007 at New Delhi.. To formulate uniform guidelines on management of acute rheumatic fever and rheumatic heart disease in the Indian context. Guidelines were formulated for the management of streptococcal pharyngitis, acute rheumatic fever and its cardiac complication as well as secondary prophylaxis for recurrent episodes.. (1) Streptococcal eradication with appropriate antibiotics (Benzathine penicillin single dose or penicillin V oral or azithromycin). (2) Diagnosis of rheumatic fever based on Jones criteria. (3) Control inflammatory process with aspirin with or without steroids (total duration of treatment of 12 weeks). (4) Treatment of chorea according to severity (therapy to continue for 2-3 weeks after clinical improvement). (5) Protocol for managing cardiac complication like valvular heart disease, congestive heart failure and atrial fibrillation. (6) Secondary prophylaxis with benzathine penicillin and management of anaphylaxis.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Humans; Penicillin G Benzathine; Pharyngitis; Rheumatic Fever; Rheumatic Heart Disease; Streptococcal Infections

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

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

Azithromycin is a macrolide antibacterial agent. The novel microspheres oral extended-release formulation (Zmax) is the first antibacterial drug approved in the US for administration as a single dose in adult patients with mild to moderate acute bacterial sinusitis (ABS) or community-acquired pneumonia (CAP). It has a broad spectrum of in vitro antibacterial activity against Gram-positive, Gram-negative and atypical pathogens that cause ABS and CAP infections (including Streptococcus pneumoniae), and achieves good tissue penetration. Azithromycin extended release is an effective and generally well tolerated treatment in patients with ABS or CAP. The clinical cure rates of a single 2.0 g dose of azithromycin extended release were noninferior to those obtained with a 10-day regimen of levofloxacin in patients with ABS, and with 7-day regimens of clarithromycin extended release or levofloxacin in patients with CAP. With a pharmacodynamic and pharmacokinetic profile well suited to administration as a single-dose regimen that may offer the advantage of improved compliance and convenience compared with once-daily longer-course regimens, azithromycin extended release is a new option in the empirical treatment of adult patients with mild or moderate ABS or CAP in the US.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Community-Acquired Infections; Delayed-Action Preparations; Humans; Macrolides; Sinusitis; United States

Haemophilus influenzae is the most common bacterial pathogen associated with acute exacerbations of chronic bronchitis (AECB). This study determined the rate of bacterial eradication of H. influenzae during AECB treated with either macrolides or moxifloxacin. Adult AECB patients with H. influenzae were included in a pooled analysis of four double-blind, multicentre, randomised trials. Patients received either moxifloxacin (400 mg qd for 5-10 days) or macrolides (azithromycin 500 mg/250 mg qd for 5 days or clarithromycin 500 mg bid for 5-10 days). Bacterial eradication and clinical success were recorded at the test-of-cure visit (7-37 days post-therapy). Of 2555 patients in the intent-to-treat population, 910 were microbiologically valid and 292 (32%) had H. influenzae cultured at baseline. Bacterial eradication of H. influenzae was significantly higher with moxifloxacin vs. macrolide-treated patients (93.0% [133/143] vs. 73.2% [109/149], respectively, P = 0.001). Moxifloxacin also demonstrated higher eradication rates compared with azithromycin (96.8% vs. 84.6%, P = 0.019) and clarithromycin (90.1% vs. 64.2%, P = 0.001) analysed separately. Clinical success was 89.5% (128/143) for moxifloxacin vs. 85.2% (127/149) for the macrolide group (P = 0.278); similar results were found when moxifloxacin was compared individually with each macrolide. For patients with AECB due to H. influenzae, moxifloxacin provided superior bacterial eradication rates than macrolide therapy.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Aza Compounds; Azithromycin; Bronchitis, Chronic; Chronic Disease; Clarithromycin; Clinical Trials, Phase III as Topic; Double-Blind Method; Female; Fluoroquinolones; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Middle Aged; Moxifloxacin; Multicenter Studies as Topic; Quinolines; Randomized Controlled Trials as Topic; Treatment Outcome

The 'Stichting Werkgroep Antibioticabeleid' (SWAB; Dutch Working Party on Antibiotic Policy) develops evidence-based guidelines for the use of antibiotics in hospitalised adults. This guideline on acute infectious diarrhoea (AID) concerns the antibiotic treatment of acute infectious inflammation of the gastrointestinal tract, manifesting primarily as diarrhoea. AID can be subdivided into community-acquired diarrhoea, traveller's diarrhoea and hospital-acquired (nosocomial) diarrhoea. In the first 2 categories, the need for antibiotic treatment is generally restricted to individuals with severe illness, dysentery or a predisposition to complications. High rates of primary fluoroquinolone resistance can be found in human Campylobacter isolates from the Netherlands and from other parts of the world. Therefore, if antibiotic treatment is necessary for community-acquired AID or AID in travellers returning to the Netherlands, it is advised to use oral azithromycin for 3 days as empirical treatment. If intravenous treatment is necessary, the combination of ciprofloxacin and erythromycin for 5-7 days may be considered. As soon as the identity of the causative organism is known, antimicrobial treatment should be tailored accordingly.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Ciprofloxacin; Diarrhea; Dysentery; Erythromycin; Evidence-Based Medicine; Humans; Netherlands; Practice Guidelines as Topic; Treatment Outcome

Acute fibrinous and organizing pneumonia, a recently described form of diffuse acute lung injury, sometimes affects adults with inflammatory myopathy. We describe a child with juvenile dermatomyositis who had development of acute fibrinous and organizing pneumonia. There does not appear to be a successful method of treatment, particularly in severe cases with respiratory failure.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Anti-Inflammatory Agents; Azithromycin; Dermatomyositis; Dyspnea; Fatal Outcome; Fatty Liver; Female; Humans; Pneumonia; Prednisone

Azithromycin is an azalide with in vitro activity against otitis media pathogens, good middle ear penetration and a prolonged half-life. A total of four clinical trials have evaluated the clinical success rate, safety and compliance of single-dose azithromycin (30 mg/kg) in the treatment of children with otitis media. Among all the patients treated with single-dose azithromycin (30 mg/kg), and presented previously in four published clinical trials, end-of-treatment clinical success was 88% (544 out of 619) and maintained clinical success at the end-of-study was 82% (498 out of 610). Three of the four studies included a mandatory baseline tympanocentesis. The overall end-of-treatment and end-of-study clinical success rates among all culture-positive patients was 84% (222 out of 263) and 80% (210 out of 263), respectively. Per pathogen end-of-treatment clinical success rates observed were 91% (125 out of 137) among patients with Streptococcus pneumoniae, 77% (75 out of 97) among patients with Haemophilus influenzae, 100% (14 out of 14) among patients with Moraxella catarrhalis, 64% (seven out of 11) among patients with baseline Streptococcus pyogenes and 25% (one out of four) among patients with a S. pneumoniae and H. influenzae mixed infection. Clinical success was observed in 90% (106 out of 118) of patients with baseline macrolide-susceptible S. pneumoniae and in 67% (14 out of 21) among patients with baseline macrolide-resistant S. pneumoniae (p = 0.01). Adverse events were uncommon, mostly mild and transitory gastrointestinal complaints, and in the two larger comparative trials, were less frequent than the rates observed with the comparator agents. Compliance was excellent (99-100%). Single-dose azithromycin (30 mg/kg) represents an alternative for the treatment of pediatric patients with uncomplicated acute otitis media, particularly in those geographic regions where high-level S. pneumoniae macrolide resistance is uncommon, and for those patients that require directly observed therapy or when compliance may be a problem.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child; Drug Administration Schedule; Humans; Otitis Media

Expert panels have recommended high-dose amoxicillin (80-90 mg/kg/day) as the therapy of choice for uncomplicated acute otitis media in children. This recommendation is based primarily on pharmacokinetic data predicting bacteriologic cure of most middle ear infections by using amoxicillin at the recommended dosage. However, comparisons of aminopenicillin-containing regimens with alternative treatments, particularly azithromycin, have not consistently demonstrated superiority of the former, even in recent trials with stringent designs. Moreover, amoxicillin exposure may perturb nasopharyngeal colonization more profoundly than do alternative agents. These perturbations may theoretically promote the dissemination of beta-lactam-resistant pneumococci in the community more than other drugs approved for use in otitis media. Such findings suggest that several factors should be considered when choosing an agent to treat otitis media and that reexamination of high-dose amoxicillin as the superior first-line agent for this condition might be warranted.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; beta-Lactams; Child; Clinical Trials as Topic; Community-Acquired Infections; Drug Resistance, Bacterial; Humans; Otitis Media

Recent management guidelines for acute exacerbation of chronic bronchitis (AECB) have provided antimicrobial options for different classes of patients according to varying disease severity or risk of treatment failure. In a pivotal, double-blind, double-dummy study comparing azithromycin microspheres (2 g single dose) with the respiratory quinolone levofloxacin (500 mg once daily x 7 days) for the treatment of AECB, the two regimens were equally effective and well tolerated in patients with mild-to-moderate disease (clinical cure rate 93.6% vs. 92.7%, respectively [95% confidence interval (CI) for difference, -3.4, 5.5] and overall bacteriological eradication rate 91.9% vs. 94.4%, respectively (95% CI for difference, -8.8, 3.8). Interestingly, additional post hoc analyses suggest that a single dose of azithromycin also provides comparable clinical efficacy to levofloxacin in patients with a forced expiratory volume in 1 s (FEV1) of less than 70% of the predicted value, a risk factor that would place them in a more severe stratum. These data support azithromycin microspheres as an appropriate option in patients with mild-to-moderate AECB. The potential role of this preparation and other macrolides in patients at higher risk of therapeutic failure requires additional prospective data.

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Azithromycin; Bronchitis; Clinical Trials as Topic; Confidence Intervals; Double-Blind Method; Drug Administration Schedule; Humans; Levofloxacin; Microspheres; Middle Aged; Ofloxacin; Severity of Illness Index; Treatment Outcome

Recurrent and persistent acute otitis media (AOM) is a common problem, affecting close to 20% of children in their first years of life. It presents a therapeutic challenge to physicians, particularly as beta-lactamase-producing Haemophilus influenzae, as well as penicillin- and, more recently, macrolide-resistant Streptococcus pneumoniae are often responsible for AOM in these patients. Intramuscular ceftriaxone (50 mg/kg, once daily for 3 days) has been shown to be effective in treating nonresponsive AOM, but there have been relatively few clinical trials exploring oral antibiotic regimens. Higher doses of commonly used antibiotics (amoxicillin-clavulanate ratio, 14:1 ratio and azithromycin 60 mg/kg divided into three equal once daily doses) have demonstrated high rates of clinical success. These studies will be discussed together with a review of the clinical and microbiologic characteristics of this disease. We will also address the impact that the pneumococcal conjugate vaccine may have on the microbiology of recurrent and persistent AOM.

Topics: Acute Disease; Azithromycin; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Prognosis; Randomized Controlled Trials as Topic; Recurrence; Severity of Illness Index; Streptococcus pneumoniae; Treatment Outcome

Topics: Acute Disease; Azithromycin; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Resistance, Bacterial; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Pharyngitis; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Severity of Illness Index; Treatment Outcome

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

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

Acute otitis media (AOM) is the most frequent bacterial disease and leading cause of antibacterial prescriptions in infants and children. Although AOM resolves spontaneously in most patients, antibacterial treatment is believed to be indicated in most industrial countries, particularly for infants, to prevent severe complications and relieve symptoms more rapidly. The classical duration of oral antibacterial therapy has been 10 days. During the last decade, the efficacy of shortened course antibacterial therapy has been demonstrated in many trials. Advantages of shorter treatment periods include less expense, better compliance, and potentially less impact on the commensal flora. However, short course antibacterial therapy may not be appropriate for children <2 years of age, particularly those attending daycare centers, those with otorrhea or a recent episode (<1 month), and otitis-prone children. Reasons for a poorer efficacy in these groups of children are still not completely understood.

Topics: Acute Disease; Administration, Oral; Anti-Infective Agents; Azithromycin; Ceftriaxone; Child; Drug Administration Schedule; Humans; Otitis Media; Randomized Controlled Trials as Topic; Treatment Outcome

The objective of this review is to examine the use of short-course antibacterial therapy of group A beta-hemolytic streptococcal (GABHS) pharyngotonsillitis, compared with traditional 10-day therapy. In preparing this paper we reviewed the medical literature of studies comparing 10 days of penicillin with shorter courses of antibacterial therapy. Short-course therapy of 6 days of amoxicillin, 4 to 5 days of cephalosporins, and 5 days of azithromycin was found to be as, or more effective than traditional 10-day penicillin therapy. The benefits of short-course therapy include superior compliance and adherence, lower incidence of adverse effects, less effect on the bacterial flora, improved patient and parent satisfaction, and lower drug costs. In conclusion, short courses of amoxicillin, cephalosporins, and macrolides provide superior or equal efficacy to a 10-day course of penicillin therapy in the treatment of GABHS pharyngotonsillitis.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cephalosporins; Child; Humans; Penicillins; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Drug Resistance, Bacterial; Humans; Otitis Media; Russia

We carried out a meta-analysis of randomized controlled trials comparing 3-5 days of azithromycin with other antibiotics that are typically given in longer courses for the treatment of upper respiratory tract infections. For acute otitis media (19 comparisons including 3421 patients), acute sinusitis (11 comparisons including 1742 patients) and acute pharyngitis (16 comparisons including 2447 patients), azithromycin had similar clinical failure rates to the other antibiotics [random effects odds ratios 1.12, 95% confidence interval (CI) 0.81-1.54; 0.91, 95% CI 0.60-1.39; and 1.07, 95% CI 0.59-1.94, respectively]. The difference in clinical failures was <0.5%, and no 95% CIs exceeded 2.0%. There was no heterogeneity between studies. Subtle differences between comparators could have been due to chance. There were no significant differences in bacteriological outcomes. Azithromycin was discontinued because of adverse events in only 37 of 4870 (0.8%) patients. Short courses of azithromycin are as effective as longer courses of other antibiotics for upper respiratory tract infections. Convenience of dosing should be balanced against the increased cost of this regimen for the treatment of these common infections, where often no antibiotic may be indicated at all.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Chi-Square Distribution; Confidence Intervals; Humans; Odds Ratio; Otitis Media; Pharyngitis; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Sinusitis

ANTIBIOTIC EFFICACY: According to early studies, antibiotics have moderate efficacy in acute exacerbation of chronic bronchitis. The lack of efficacy is particularly clear for patent exacerbation with marked alteration of respiratory function. Recent studies have shown that newer compounds exhibit an efficacy similar (no proven superiority) to comparison compounds (75 to 95% favorable outcome with treatment). The recommendations of the IVth Consensus Conference on Anti-infectious Therapy thus propose first line antibiotic therapy for patients with a forced expiratory volume in 1 second (FEV1) between 80 and 35% and broader spectrum and new antibiotics in case of failure of the first line treatment for patients with severe obstruction or frequently recurrent exacerbation.. Using exacerbation-free interval, reduction in the number of exacerbations, duration of treatment and/or hospital stay as evaluation criteria, interesting results are obtained with amoxicillin/clavulanic acid, azithromycin, and ciprofloxacin. Independent factors predictive of therapeutic failure are, according to one study, FEV1 less than 35%, ambulatory administration of oxygen, more than 4 acute exacerbations within 24 months, history of pneumonia or sinusitis, and requirement for long-term corticosteroid therapy. Factors predictive of recurrence are, according to another study, dependence on oxygen therapy, prolonged corticosteroid therapy, smoking, and/or heart disease. Cost effectiveness is particularly interesting with ciprofloxacin, especially in more severe patients.. It is important to target antibiotic therapy for acute exacerbation of chronic bronchitis specifically for patients who will truly benefit, adapting the prescribed compound to the bacterial target.

Topics: Acute Disease; Adrenal Cortex Hormones; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin; Bronchitis, Chronic; Ciprofloxacin; Clavulanic Acid; Clinical Trials as Topic; Cost-Benefit Analysis; Double-Blind Method; Drug Therapy, Combination; Erythromycin; Humans; Maximal Expiratory Flow-Volume Curves; Multicenter Studies as Topic; Penicillins; Placebos; Practice Guidelines as Topic; Prognosis; Recurrence; Respiratory Function Tests; Tetracycline; Time Factors; Trimethoprim, Sulfamethoxazole Drug Combination

Otitis media is a common pediatric problem, for which antibiotics are frequently prescribed.. To determine the effectiveness of a short course of antibiotics (less than seven days) in comparison to a longer course (seven days or greater) for the treatment of acute otitis media in children.. The medical literature was searched for randomized controlled studies of the treatment of ear infections in children with antibiotics published from January 1966 to July 1997. Search last updated March 1998.. Studies were included if they met the following criteria: subjects one month to 18 years of age, clinical diagnosis of ear infection, no previous antimicrobial therapy and randomization to treatment with less than seven days versus seven days or more of antibiotics.. Data on treatment outcomes were extracted from individual studies, and combined in the form of a summary odds ratio. A summary odds ratio (OR) equivalent to one indicated that the treatment failure rate following less than seven days of antibiotic treatment was similar to the failure rate following seven days or more of antibiotic.. The summary OR for treatment outcomes at eight to 19 days in 1,524 children treated with short-acting antibiotics for five days versus eight to 10 days was 1.52, 95% CI: 1.17-1.98, but by 20 to 30 days outcomes between treatment groups (n=2,115) were comparable (OR=1.22, 95% CI:0.98-1.54). The absolute difference in treatment failure (Random effects model RD=2.9%, 95%CI:-0.3% to 6.1%) at 20 to 30 days suggests that at minimum 17 children would need to be treated with the long course of short-acting antibiotics to avoid one treatment failure. Similarity in outcomes was observed for up to three months following therapy (OR=1.16,95% CI=0.9-1.5). Comparable outcomes were shown between treatment with ceftriaxone or azithromycin, and more than seven days of other antibiotics.. This review suggests that five days of short-acting antibiotic is effective treatment for uncomplicated ear infections in children.

Topics: Acute Disease; Age Factors; Anti-Bacterial Agents; Azithromycin; Child; Drug Administration Schedule; Humans; Otitis Media

To conduct a meta-analysis of randomized controlled trials of antibiotic treatment of acute otitis media in children to determine whether outcomes were comparable in children treated with antibiotics for less than 7 days or at least 7 days or more.. MEDLINE (1966-1997), EMBASE (1974-1997), Current Contents, and Science Citation Index searches were conducted to identify randomized controlled trials of the treatment of acute otitis media in children with antibiotics of different durations.. Studies were included if they met the following criteria: subjects aged 4 weeks to 18 years, clinical diagnosis of acute otitis media, no antimicrobial therapy at time of diagnosis, and randomization to less than 7 days of antibiotic treatment vs 7 days or more of antibiotic treatment.. Trial methodological quality was assessed independently by 7 reviewers; outcomes were extracted as the number of treatment failures, relapses, or reinfections.. Included trials were grouped by antibiotic used in the short course: (1) 15 short-acting oral antibiotic trials (penicillin V potassium, amoxicillin [-clavulanate], cefaclor, cefixime, cefuroxime, cefpodoxime proxetil, cefprozil), (2) 4 intramuscularceftriaxone sodium trials, and (3) 11 oral azithromycin trials. The summary odds ratio for treatment outcomes at 8 to 19 days in children treated with short-acting antibiotics for 5 days vs 8 to 10 days was 1.52 (95% confidence interval [CI], 1.17-1.98) but by 20 to 30 days outcomes between treatment groups were comparable (odds ratio, 1.22; 95% CI, 0.98 to 1.54). The risk difference (2.3%; 95% CI,-0.2% to 4.9%) at 20 to 30 days suggests that 44 children would need to be treated with the long course of short-acting antibiotics to avoid 1 treatment failure. This similarity in later outcomes was observed for up to 3 months following therapy (odds ratio, 1.16; 95% CI, 0.90-1.50). Comparable outcomes were shown between treatment with ceftriaxone or azithromycin, and at least 7 days of other antibiotics.. This meta-analysis suggests that 5 days of short-acting antibiotic use is effective treatment for uncomplicated acute otitis media in children.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Cephalosporins; Child; Drug Administration Schedule; Humans; Otitis Media; Randomized Controlled Trials as Topic; Treatment Outcome

Azithromycin is a molecule of the macrolide family, belonging to the azalides class. Several of its characteristics allow for its use in the treatment of the community-acquired lower respiratory tract infections. Commonly isolated pathogens in bronchial infections are most frequently H. influenzae, S. pneumoniae, M. catarrhalis, C. pneumoniae and M. pneumoniae, and more rarely or in the context of a particular background, S. aureus, Gram negative bacteria and L. pneumophila. MIC90 of these germs is generally low or slightly elevated, displaying an inhibitory activity of the azithromycin on these bacteria. Nevertheless, the frequency of macrolide-resistant S. pneumoniae is not negligible and this germ must be considered as inconstantly susceptible to the macrolide family. Pharmacokinetics studies evidenced from high to very high azithromycin concentrations in the pulmonary tissues, reaching values well above MIC of pathogens commonly isolated. Given the long half-life, these concentrations persist a long time after oral administration. As azithromycin concentrates much in polymorphonuclear leucocytes, they release azithromycin after having migrated into the infectious site by chimiotactism, thus allowing to increase the antibiotic concentration at infection site. These requirements have been confirmed in vivo in animal models and in clinical studies. Two experimental models on macrolide susceptible S. pneumoniae, and H. influenzae evidenced a better activity of azithromycin in comparison to other macrolides tested against these two germs.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Azithromycin; Bronchitis; Chronic Disease; Community-Acquired Infections; Haemophilus Infections; Humans; Mice; Pneumonia, Bacterial; Pneumonia, Mycoplasma; Pneumonia, Pneumococcal

World Health Organization (WHO) guidelines do not recommend routine antibiotic use for children with acute watery diarrhea. However, recent studies suggest that a significant proportion of such episodes have a bacterial cause and are associated with mortality and growth impairment, especially among children at high risk of diarrhea-associated mortality. Expanding antibiotic use among dehydrated or undernourished children may reduce diarrhea-associated mortality and improve growth.. To determine whether the addition of azithromycin to standard case management of acute nonbloody watery diarrhea for children aged 2 to 23 months who are dehydrated or undernourished could reduce mortality and improve linear growth.. The Antibiotics for Children with Diarrhea (ABCD) trial was a multicountry, randomized, double-blind, clinical trial among 8266 high-risk children aged 2 to 23 months presenting with acute nonbloody diarrhea. Participants were recruited between July 1, 2017, and July 10, 2019, from 36 outpatient hospital departments or community health centers in a mixture of urban and rural settings in Bangladesh, India, Kenya, Malawi, Mali, Pakistan, and Tanzania. Each participant was followed up for 180 days. Primary analysis included all randomized participants by intention to treat.. Enrolled children were randomly assigned to receive either oral azithromycin, 10 mg/kg, or placebo once daily for 3 days in addition to standard WHO case management protocols for the management of acute watery diarrhea.. Primary outcomes included all-cause mortality up to 180 days after enrollment and linear growth faltering 90 days after enrollment.. A total of 8266 children (4463 boys [54.0%]; mean [SD] age, 11.6 [5.3] months) were randomized. A total of 20 of 4133 children in the azithromycin group (0.5%) and 28 of 4135 children in the placebo group (0.7%) died (relative risk, 0.72; 95% CI, 0.40-1.27). The mean (SD) change in length-for-age z scores 90 days after enrollment was -0.16 (0.59) in the azithromycin group and -0.19 (0.60) in the placebo group (risk difference, 0.03; 95% CI, 0.01-0.06). Overall mortality was much lower than anticipated, and the trial was stopped for futility at the prespecified interim analysis.. The study did not detect a survival benefit for children from the addition of azithromycin to standard WHO case management of acute watery diarrhea in low-resource settings. There was a small reduction in linear growth faltering in the azithromycin group, although the magnitude of this effect was not likely to be clinically significant. In low-resource settings, expansion of antibiotic use is not warranted. Adherence to current WHO case management protocols for watery diarrhea remains appropriate and should be encouraged.. ClinicalTrials.gov Identifier: NCT03130114.

Topics: Acute Disease; Administration, Oral; Ambulatory Care; Anti-Bacterial Agents; Azithromycin; Child Development; Dehydration; Diarrhea; Double-Blind Method; Drug Administration Schedule; Female; Health Resources; Humans; Infant; Male; Malnutrition; Treatment Outcome

Respiratory failure requiring endotracheal intubation accounts for a significant proportion of intensive care unit (ICU) admissions. Little attention has been paid to the laryngeal consequences of endotracheal intubation. Acute laryngeal injury (ALgI) after intubation occurs at the mucosal interface of the endotracheal tube and posterior larynx and although not immediately manifest at extubation, can progress to mature fibrosis, restricted glottic mobility and clinically significant ventilatory impairment. A recent prospective observational study has shown that >50% of patients intubated >24 hours in an ICU develop ALgI. Strikingly, patients with AlgI manifest significantly worse subjective breathing at 12 weeks. Current ALgI treatments are largely surgical yet offer a marginal improvement in symptoms.. The Institutional Review Board (IRB) Committee of the Vanderbilt University Medical Center has approved this protocol (IRB #171066). The findings of the trial will be disseminated through peer-reviewed journals, national and international conferences.. NCT03250975.

Topics: Acute Disease; Azithromycin; Budesonide; Double-Blind Method; Early Medical Intervention; Humans; Intensive Care Units; Intubation, Intratracheal; Larynx; Noninvasive Ventilation; Prospective Studies; Randomized Controlled Trials as Topic; Tennessee; Time Factors; Wounds and Injuries

The aim of this open-label, randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic, and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment.. To be included, children aged between 6 months and 2 years are preselected based on mid-upper-arm circumference (MUAC) and are included based on a weight-for-height Z-score (WHZ) between - 3 and - 2 standard deviations (SD). As per current protocols, children receive renutrition treatment for 12 weeks and are assessed weekly to determine improvement. The primary endpoint is recovery, defined by a WHZ ≥ - 1.5 SD after 12 weeks of treatment. Data collected include clinical and socioeconomic characteristics, side effects, compliance and tolerance to interventions. Metagenomic analysis of gut microbiota is conducted at inclusion, 3 months, and 6 months. The cognitive development of children is evaluated in Senegal using only the Developmental Milestones Checklist II (DMC II) questionnaire at inclusion and at 3, 6, and 9 months. The data will be correlated with renutrition efficacy and metagenomic data.. This study will provide new insights for the treatment of MAM, as well as original data on the modulation of gut microbiota during the renutrition process to support (or not) the microbiota hypothesis of malnutrition.. ClinicalTrials.gov, ID: NCT03474276 Last update 28 May 2018.

Topics: Acute Disease; Africa; Age Factors; Albendazole; Anti-Bacterial Agents; Antiparasitic Agents; Azithromycin; Child Development; Child, Preschool; Female; Flour; Food, Fortified; Gastrointestinal Microbiome; Humans; Infant; Infant Nutrition Disorders; Infant Nutritional Physiological Phenomena; Male; Malnutrition; Multicenter Studies as Topic; Nutritional Status; Prebiotics; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome

Sudden and severe onset of obsessive-compulsive disorder (OCD) may present secondary to infectious and/or immune-mediated triggers. We assessed the preliminary efficacy, tolerability, and safety of azithromycin compared with placebo in the treatment of OCD and associated symptoms in children with pediatric acute-onset neuropsychiatric syndrome (PANS).. Thirty-one youth aged 4-14 years (M = 8.26 ± 2.78 years, 62.5% male) were randomized to receive either placebo or azithromycin for 4 weeks (10 mg/kg up to 500 mg per day). Both groups were administered twice daily probiotics. The primary outcome, obsessive-compulsive symptom severity, was assessed using the OCD Clinical Global Impressions Severity (CGI-S OCD) and Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).. Participants in the azithromycin group (n = 17) showed significantly greater reductions in OCD severity on the CGI-S OCD than the placebo group (n = 14) posttreatment (p = 0.003), although there were no significant differences on the CY-BOCS. Significantly more participants in the azithromycin condition met treatment responder criteria on the CGI-I OCD at the end of week 4 (41.2%, n = 7) in comparison to the placebo group (7.1%, n = 1; p = 0.045). Tic severity moderated treatment response, with greater tic severity being associated with enhanced treatment response on the CGI-S OCD. Azithromycin was well tolerated with minimal adverse effects and no study dropouts due to side effects. However, the azithromycin group showed a trend toward significantly greater electrocardiography QTc (p = 0.060) at the end of week 4, and significantly more reports of loose or abnormal stools (p = 0.009).. This double blind pilot study suggests that azithromycin may be helpful in treating youth meeting the PANS diagnosis, especially those with elevated levels of both OCD and tic symptoms. Azithromycin was well tolerated, but the potential for cardiac risks suggests that additional monitoring may be needed to ensure safety.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Double-Blind Method; Female; Humans; Male; Obsessive-Compulsive Disorder; Pilot Projects

Recommended treatment for travelers' diarrhea includes the combination of an antibiotic, usually a fluoroquinolone or azithromycin, and loperamide for rapid resolution of symptoms. However, adverse events, postdose nausea with high-dose azithromycin, effectiveness of single-dose rifaximin, and emerging resistance to front-line agents are evidence gaps underlying current recommendations.. A randomized, double-blind trial was conducted in 4 countries (Afghanistan, Djibouti, Kenya, and Honduras) between September 2012 and July 2015. US and UK service members with acute watery diarrhea were randomized and received single-dose azithromycin (500 mg; 106 persons), levofloxacin (500 mg; 111 persons), or rifaximin (1650 mg; 107 persons), in combination with loperamide (labeled dosing). The efficacy outcomes included clinical cure at 24 hours and time to last unformed stool.. Clinical cure at 24 hours occurred in 81.4%, 78.3%, and 74.8% of the levofloxacin, azithromycin, and rifaximin arms, respectively. Compared with levofloxacin, azithromycin was not inferior (P = .01). Noninferiority could not be shown with rifaximin (P = .07). At 48 and 72 hours, efficacy among regimens was equivalent (approximately 91% at 48 and 96% at 72 hours). The median time to last unformed stool did not differ between treatment arms (azithromycin, 3.8 hours; levofloxacin, 6.4 hours; rifaximin, 5.6 hours). Treatment failures were uncommon (3.8%, 4.4%, and 1.9% in azithromycin, levofloxacin, and rifaximin arms, respectively) (P = .55). There were no differences between treatment arms with postdose nausea, vomiting, or other adverse events.. Single-dose azithromycin, levofloxacin, and rifaximin with loperamide were comparable for treatment of acute watery diarrhea.. NCT01618591.

Topics: Acute Disease; Adult; Afghanistan; Anti-Bacterial Agents; Azithromycin; Diarrhea; Djibouti; Double-Blind Method; Drug Therapy, Combination; Escherichia coli; Escherichia coli Infections; Female; Honduras; Humans; Kenya; Levofloxacin; Loperamide; Male; Military Personnel; Travel; Treatment Outcome

Cutaneous leishmaniasis (CL) treatment is based on pentavalant antimony (sbv) drugs which are accompanied by many side effects and are facing ever-increasing resistance. Topical treatment of CL is an attractive alternative avoiding toxicities of parenteral therapy while being administered through a simple painless route. The liposomal formulations of different drugs have recently been increasingly used in the treatment of several types of leishmaniasis. The efficacy of a topical liposomal azithromycin formulation was compared with intralesional meglumine antimoniate (glucantime) in the treatment of CL. Sixty-six patients with 97 lesions who met our inclusion criteria were randomly divided into two groups. One group was administered with the topical liposomal form of azithromycin twice daily. The other group was treated by weekly intralesional injections of glucantime with a volume of 0.5-2 cm3 into each lesion till complete blanching of the lesion occurred. Clinical evaluations were performed weekly during the treatment course (8 weeks) by a single dermatologist for both groups. Per-protocol analysis showed no statistically significant difference between the two groups (p = 0.84, 95% confidence interval (CI) = 0.764 (0.714-0.821). Serious drug side effects were not observed in either group. Topical liposomal azithromycin has the same efficacy as intralesional glucantime in the treatment of CL.

Topics: Acute Disease; Administration, Cutaneous; Adolescent; Adult; Antiprotozoal Agents; Azithromycin; Child; Drug Administration Schedule; Female; Humans; Injections, Intralesional; Iran; Leishmaniasis, Cutaneous; Liposomes; Male; Meglumine; Meglumine Antimoniate; Middle Aged; Organometallic Compounds; Time Factors; Treatment Outcome; Young Adult

Long-term use of macrolide antibiotics is effective to prevent exacerbations in chronic obstructive pulmonary disease (COPD). As risks and side effects of long-term intervention outweigh the benefits in the general COPD population, the optimal dose, duration of treatment, and target population are yet to be defined. Hospitalization for an acute exacerbation (AE) of COPD may offer a targeted risk group and an obvious risk period for studying macrolide interventions.. Patients with COPD, hospitalized for an AE, who have a smoking history of ≥10 pack-years and had ≥1 exacerbation in the previous year will be enrolled in a multicenter, randomized, double-blind, placebo-controlled trial (NCT02135354). On top of a standardized treatment of systemic corticosteroids and antibiotics, subjects will be randomized to receive either azithromycin or placebo during 3 months, at an uploading dose of 500 mg once a day for 3 days, followed by a maintenance dose of 250 mg once every 2 days. The primary endpoint is the time-to-treatment failure during the treatment phase (ie, from the moment of randomization until the end of intervention). Treatment failure is a novel composite endpoint defined as either death, the admission to intensive care or the requirement of additional systemic steroids or new antibiotics for respiratory reasons, or the diagnosis of a new AE after discharge.. We investigate whether azithromycin initiated at the onset of a severe exacerbation, with a limited duration and at a low dose, might be effective and safe in the highest risk period during and immediately after the acute event. If proven effective and safe, this targeted approach may improve the treatment of severe AEs and redirect the preventive use of azithromycin in COPD to a temporary intervention in the subgroup with the highest unmet needs.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Disease Progression; Double-Blind Method; Hospitalization; Humans; Pulmonary Disease, Chronic Obstructive; Research Design

Pelvic inflammatory disease (PID) is mainly caused by ascending infection from the vaginal flora including the sexually transmitted organisms, Neisseria gonorrhoeae and Chlamydia trachomatis, and lower genital tract endogenous anaerobes, leading to serious consequences including infertility and ectopic pregnancy. To evaluate the efficacy and safety of azithromycin in the treatment of PID that requires initial intravenous therapy, we conducted a multicenter, unblinded, non-comparative phase 3 trial. Intravenous azithromycin (500 mg, once daily) for 1 or 2 days followed by oral azithromycin (250 mg once daily) to complete a total of 7 days treatment was administered to 60 Japanese women with acute PID. The clinical and bacteriological responses were assessed at the end of treatment, and on Days 15 and 29. The most commonly detected baseline causative pathogens were C. trachomatis (12 strains), Prevotella bivia (10 strains), Streptococcus agalactiae (7 strains), N. gonorrhoeae and Peptostreptococcus anaerobius (6 strains each). The clinical success rate on Day 15 was 94.1% (48/51 subjects including perihepatitis). The clinical efficacy and bacterial eradication rates against C. trachomatis and N. gonorrhoeae (including 2 quinolone-resistant strains) were both 100%. Common treatment-related adverse events were diarrhoea, injection site pain, and nausea. All adverse events were mild or moderate in severity. Azithromycin intravenous-to-oral switch therapy demonstrated excellent clinical and bacteriological effects for PID caused by various etiologic agents including quinolone-resistant strains and strains with low susceptibility to azithromycin at in vitro testing. The therapy was well tolerated in the treatment of PID in Japanese women.. NCT00871494.

Topics: Acute Disease; Administration, Intravenous; Administration, Oral; Adolescent; Adult; Anti-Bacterial Agents; Azithromycin; Female; Hepatitis; Humans; Intraabdominal Infections; Japan; Middle Aged; Pelvic Inflammatory Disease

Ensuring adherence to treatment and retention is important in clinical trials, particularly in remote areas and minority groups. We describe a novel approach to improve adherence, retention and clinical review rates of Indigenous children.. This descriptive study was nested within a placebo-controlled, randomised trial (RCT) on weekly azithromycin (or placebo) for 3-weeks. Indigenous children aged ≤24-months hospitalised with acute bronchiolitis were recruited from two tertiary hospitals in northern Australia (Darwin and Townsville). Using mobile phones embedded within a culturally-sensitive approach and framework, we report our strategies used and results obtained. Our main outcome measure was rates of adherence to medications, retention in the RCT and self-presentation (with child) to clinic for a clinical review on day-21.. Of 301 eligible children, 76 (21%) families declined participation and 39 (13%) did not have access to a mobile phone. 186 Indigenous children were randomised and received dose one under supervision in hospital. Subsequently, 182 (99%) children received dose two (day-7), 169 (93%) dose three (day-14) and 180 (97%) attended their clinical review (day-21). A median of 2 calls (IQR 1-3) were needed to verify adherence. Importantly, over 97% of children remained in the RCT until their clinical endpoint at day-21.. In our setting, the use of mobile phones within an Indigenous-appropriate framework has been an effective strategy to support a clinical trial involving Australian Indigenous children in urban and remote Australia. Further research is required to explore other applications of this approach, including the impact on clinical outcomes.. ACTRN12608000150347 (RCT component).

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Bronchiolitis; Cell Phone; Female; Health Services, Indigenous; Humans; Infant; Male; Medication Adherence; Native Hawaiian or Other Pacific Islander; Northern Territory; Reminder Systems

Low blood levels of 25-hydroxyvitamin D (25[OH]D) have been associated with a higher risk of respiratory infections in general populations and higher risk of exacerbations of lung disease in people with asthma. We hypothesized that low blood levels of 25(OH)D in patients with chronic obstructive pulmonary disease (COPD) would be associated with an increased risk of acute exacerbations of COPD (AECOPD).. To determine if baseline 25(OH)D levels relate to subsequent AECOPD in a cohort of patients at high risk for AECOPD.. Plasma 25(OH)D was measured at baseline in 973 participants on entry to a 1-year study designed to determine if daily azithromycin decreased the incidence of AECOPD. Relationships between baseline 25(OH)D and AECOPD over 1 year were analyzed with time to first AECOPD as the primary outcome and exacerbation rate as the secondary outcome.. In this largely white (85%) sample of North American patients with severe COPD (mean FEV(1) 1.12L; 40% of predicted), mean 25(OH)D was 25.7 ± 12.8 ng/ml. A total of 33.1% of participants were vitamin D insufficient (≥20 ng/ml but <30 ng/ml); 32% were vitamin D deficient (<20 ng/ml); and 8.4% had severe vitamin D deficiency (<10 ng/ml). Baseline 25(OH)D levels had no relationship to time to first AECOPD or AECOPD rates.. In patients with severe COPD, baseline 25(OH)D levels are not predictive of subsequent AECOPD. Clinical trial registered with www.clinicaltrials.gov (NCT00119860).

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Azithromycin; Biomarkers; Female; Humans; Male; Middle Aged; Proportional Hazards Models; Prospective Studies; Pulmonary Disease, Chronic Obstructive; Recurrence; Risk; Vitamin D; Vitamin D Deficiency

To test the hypothesis that azithromycin reduces the length of hospitalization and oxygen requirement in infants with acute viral bronchiolitis (AB).. We performed a randomized, double-blinded, placebo-controlled trial in southern Brazil, from 2009 to 2011. Infants (<12 months of age) hospitalized with AB were recruited in 2 hospitals. Patients were randomized to receive either azithromycin or placebo, administered orally, for 7 days. At enrollment, clinical data were recorded and nasopharyngeal samples were collected for viral identification through immunofluorescence. Main outcomes were duration of oxygen requirement and length of hospitalization.. One hundred eighty-four patients were included in the study (azithromycin 88 subjects, placebo 96 subjects). Baseline clinical characteristics and viral identification were not different between the groups studied. A virus was detected in 112 (63%) patients, and of those, 92% were positive for respiratory syncytial virus. The use of azithromycin did not reduce the median number of days of either hospitalization (P = .28) or oxygen requirement (P = .47).. Azithromycin did not improve major clinical outcomes in a large sample of hospitalized infants with AB, even when restricting the findings to those with positive respiratory syncytial virus samples. Azithromycin therapy should not be given for AB because it provides no benefit and overuse increases overall antibiotic resistance.

Topics: Acute Disease; Administration, Oral; Anti-Inflammatory Agents; Azithromycin; Bronchiolitis, Viral; Combined Modality Therapy; Double-Blind Method; Drug Administration Schedule; Female; Hospitalization; Humans; Infant; Infant, Newborn; Influenza, Human; Kaplan-Meier Estimate; Length of Stay; Male; Oxygen Inhalation Therapy; Paramyxoviridae Infections; Respiratory Syncytial Virus Infections; Treatment Outcome

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

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

To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis.. Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study.. Eligible male or female participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy.. Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n = 149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 (P < .001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups.. Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Conjunctivitis, Bacterial; Double-Blind Method; Female; Gram-Negative Bacteria; Gram-Negative Bacterial Infections; Gram-Positive Bacteria; Gram-Positive Bacterial Infections; Humans; Infant; Male; Microbial Sensitivity Tests; Middle Aged; Ophthalmic Solutions; Pharmaceutical Vehicles; Prospective Studies

As high drug levels at the infection site are desirable for optimal activity, this study explored whether one dose of azithromycin extended release (AZ-ER) achieved higher azithromycin exposure in sinus fluid than azithromycin immediate release (AZ-IR) in adults with acute bacterial sinusitis. Subjects received AZ-ER (2g single dose; n=5) or AZ-IR (500mg daily for 3 days; n=4) and blood and sinus aspirates were collected until 120 h after initial dosing. Within 24 h, exposure was four- and three-fold higher with AZ-ER than with AZ-IR in serum and sinus fluid, respectively. Sinus fluid exposure was five- and three-fold higher than serum for AZ-IR and AZ-ER, respectively. Azithromycin concentrations in sinus fluid were maintained up to 120 h.

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Area Under Curve; Azithromycin; Body Fluids; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Delayed-Action Preparations; Dose-Response Relationship, Drug; Female; Humans; Male; Mass Spectrometry; Middle Aged; Paranasal Sinuses; Sinusitis

The use of short-term intramuscular ceftriaxone for pediatric ambulatory conditions raises concerns regarding the promotion of resistance among colonizing enteric bacteria. This study was designed to assess the prevalence of stool colonization with resistant Gram-negative bacilli after single-dose ceftriaxone treatment compared with other regimens for acute otitis media.. Children age 3 months to 7 years and diagnosed with acute otitis media were randomized to receive treatment with single-dose ceftriaxone or with oral cefprozil, amoxicillin or azithromycin. Stool samples were obtained at enrollment and then 3-5 days, 10-14 days, and 28-30 days after therapy was initiated and screened for the presence of facultative Gram-negative bacilli resistant to ceftriaxone, cefprozil, amoxicillin, piperacillin, piperacillin-tazobactam and tobramycin. Mean prevalence of colonization by resistant organisms for each treatment group was compared at each time point.. One thousand nine subjects were enrolled. The prevalence of colonization by a Gram-negative bacillus resistant to at least 1 of the screening antibiotics decreased after receipt of ceftriaxone but returned close to values measured at study entry by 30 days. A qualitatively similar pattern was noted for the 3 other regimens, but a quantitatively greater decrease in the prevalence of colonization by a resistant bacterium was noted at the 3- to 5-day and 10- to 14-day visits among azithromycin recipients (P < 0.001). Colonization by a Gram-negative bacillus resistant specifically to ceftriaxone was unusual at each study visit, regardless of treatment assignment.. A single intramuscular dose of ceftriaxone had a similar effect on the prevalence of antibiotic-resistant Gram-negative facultative bacilli in the stool of healthy children when compared with commonly used oral agents.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cefprozil; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Drug Resistance; Feces; Female; Gram-Negative Bacteria; Humans; Infant; Injections, Intramuscular; Male; Otitis Media

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

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

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

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

To explore the efficacy of the ketolide telithromycin compared with azithromycin in eradicating S pneumoniae from the nasopharynx of adults with acute maxillary sinusitis. The growing resistance of Streptococcus pneumoniae to penicillin and macrolides brought about the development of a new class of antibiotics-the ketolides-that are effective against resistant pneumococci.. Otolaryngology clinic.. One-hundred five patients with acute maxillary sinusitis.. Nasopharyngeal cultures were obtained before therapy and 10 to 12 days after initiation of treatment. Fifty-nine patients were treated with 500 mg of azithromycin daily for 3 days and 46 were treated with 800 mg of telithromycin daily for 5 days.. Sixty-seven potential pathogens were recovered prior to initiation of therapy in 57 patients, 32 treated with telithromycin and 25 treated with azithromycin: S pneumoniae (31 isolates), Haemophilus influenzae (non-type b) (13), Staphylococcus aureus (8), Streptococcus pyogenes (8), and Moraxella catarrhalis (7). The distribution of the pathogens was similar in both groups. The number of S pneumoniae isolates in the azithromycin group was reduced following treatment from 14 to 8 (43% reduction), and 5 of these 8 isolates were resistant to azithromycin. In contrast, the number of S pneumoniae isolates in the telithromycin group was reduced following treatment from 17 to 1 (94% reduction) (P < .01). This isolate was susceptible to azithromycin and telithromycin. No differences were noted in the eradication rate of all of the other potential pathogens, which were all susceptible to both azithromycin and telithromycin. Development of resistance to the antimicrobial agents used (defined as increase in the minimal inhibitory concentration by at least 2 tubes) was found only in 5 isolates (4 S pneumoniae and 1 H influenzae) recovered only from patients who received azithromycin (P < .05).. These data illustrate the superiority of telithromycin to azithromycin in the eradication of S pneumoniae from the nasopharynx.

Topics: Acute Disease; Adolescent; Adult; Anti-Bacterial Agents; Azithromycin; Drug Resistance, Bacterial; Female; Humans; Ketolides; Male; Maxillary Sinusitis; Middle Aged; Pneumococcal Infections; Streptococcus pneumoniae

This study evaluated the natural history of acute tonsillopharyngitis associated with atypical bacterial infections, showing that Mycoplasma pneumoniae and Chlamydia pneumoniae organisms are frequently found in children with acute tonsillopharyngitis. The study also demonstrated, for what we believe to be the first time, that, unless adequately treated, acute tonsillopharyngitis associated with infection with M. pneumoniae and C. pneumoniae may have a negative outcome with a high risk of recurrence of respiratory illness.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Antibodies, Bacterial; Azithromycin; Child; Child, Preschool; Chlamydophila Infections; Chlamydophila pneumoniae; Disease Progression; Female; Humans; Infant; Male; Mycoplasma Infections; Mycoplasma pneumoniae; Pharyngeal Diseases; Pharyngitis; Recurrence; Tonsillitis; Treatment Outcome

To compare the efficacy and safety of oral azithromycin 500 mg once daily for 3 days with those of oral clarithromycin 500 mg twice daily for 10 days.. Randomized, double-blind, double-dummy, multicenter study.. Seventy-six study centers in eight countries (Argentina, Brazil, Canada, Chile, Costa Rica, India, South Africa, and USA).. Three hundred and twenty-two adult outpatients with acute exacerbation of chronic bronchitis (AECB) as documented by increased cough or sputum production, worsening dyspnea, and purulent sputum production.. Randomization 1 : 1 to azithromycin 500 mg once daily for 3 days or clarithromycin 500 mg twice daily for 10 days.. The primary efficacy endpoint was clinical response at day 21-24, or test of cure (TOC) visit in the modified intent-to-treat (MITT) analysis (n = 318 patients). The TOC clinical cure rates in the MITT population were equivalent in the two treatment groups at 85% with azithromycin and 82% with clarithromycin (95% CI -5.9%, 12.0%). Clinical success rates on day 10-12 were also equivalent at 93% with azithromycin and 94% with clarithromycin (95% CI -7.9%, 4.4%). Clinical cure rates at TOC by pathogen were equivalent for the two treatment groups for Haemophilus influenzae (azithromycin, 85.7%; clarithromycin, 87.5%), Moraxella catarrhalis (91.7% and 80.0%, respectively) and Streptococcus pneumoniae (90.6% and 77.8%, respectively). Bacteriologic success rates were also equivalent between the azithromycin and clarithromycin treatment groups at TOC for S. pneumoniae (90.6% and 85.2%, respectively), H. influenzae (71.4% and 81.3%, respectively) and M. catarrhalis (100% and 86.7%, respectively). The overall incidence of treatment-related adverse events was similar in the azithromycin and clarithromycin groups (20.9% and 26.8%, respectively), with the most common being abdominal pain (6.3% and 6.1%, respectively), diarrhea (4.4% and 5.5%, respectively), and nausea (4.4% and 3.7%, respectively).. Three-day treatment with azithromycin 500 mg once daily is equivalent to a 10-day treatment with clarithromycin 500 mg twice daily in adult patients with AECB.

Topics: Acute Disease; Administration, Oral; Anti-Bacterial Agents; Azithromycin; Bronchitis, Chronic; Clarithromycin; Double-Blind Method; Drug Administration Schedule; Female; Haemophilus influenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Streptococcus pneumoniae; Treatment Outcome

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

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

To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS).. An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients > or =18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24).. Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group.. Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin.. A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.

Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Azithromycin; Bacterial Infections; Chemistry, Pharmaceutical; Confidence Intervals; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; International Cooperation; Levofloxacin; Male; Maxillary Sinusitis; Microspheres; Middle Aged; Ofloxacin; Probability; Risk Assessment; Severity of Illness Index; Treatment Outcome

Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance.. In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25).. Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each).. Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Oral; Analgesics; Analgesics, Non-Narcotic; Anti-Infective Agents; Anti-Inflammatory Agents; Azithromycin; Cefdinir; Cephalosporins; Child, Preschool; Diarrhea; Drug Administration Schedule; Female; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Male; Meningococcal Vaccines; Otitis Media; Pneumococcal Vaccines; Prospective Studies; Single-Blind Method; Streptococcus pneumoniae; Time Factors; Treatment Outcome; Tympanic Membrane

The 3-day course of azithromycin (AZM) 500 mg/d was introduced to the US market in June 2002.. The objective of this study was to evaluate changes in health-related quality of life (HRQOL) as measured by the St. George's Respiratory Questionnaire (SGRQ) over a 1-month period in patients receiving a 3-day course of AZM for bacterial acute exacerbation of chronic bronchitis (AECB).. This was a prospective, multicenter, observational study evaluating outpatient adults with AECB who received either 3 days of AZM 500 mg/d or 5- to 14-day courses of other antibiotics (usual care [UC]) as directed by the clinician. Patients completed 2 HRQOL instruments-the SGRQ and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)-at baseline, day 14, and end of study (EOS) at days 24 to 28. In addition, patients kept a diary for the first 14 days after initiating antibiotic therapy.. One hundred twenty-eight patients (57 AZM, 71 UC) were clinically evaluable. There were no significant differences between treatment groups in clinical presentation or baseline demographics, with the exception of a higher percentage of patients with diabetes mellitus in the UC group compared with the AZM group (16.9% vs 3.5%; P = 0.02). Both groups reported similar improvements in signs and symptoms, absenteeism, concomitant respiratory medication use, resource utilization, compliance, and treatment satisfaction as reported in the patient diary. The AZM group reported statistically significant improvement (simple contrasts for end of study vs baseline) in SGRQ measures (total score, P < 0.001; symptoms, P = 0.031; activity, P < 0.001; impacts, P < 0.001) and the SF-36 mental and physical summary components, compared with baseline (both, P < 0.001). Similarly, the UC group reported significant improvement in all SGRQ measures and in the SF-36 physical component score (P < 0.01), but not in the SF-36 mental component score, compared with baseline. At EOS, 80.0% of AZM patients and 59.0% of UC patients had a > or =4-point improvement on the SGRQ total score; however, this difference was not statistically significant in the multivariate analysis. In addition, 89.5% of AZM patients and 89.9% of UC patients were satisfied or very satisfied with their treatment (P = NS). Resource utilization was similar between the groups.. In this observational study, patients with AECB treated with a 3-day course of AZM experienced significant improvements in HRQOL as measured by a change of > or =4 points on the SGRQ and SF-36 physical and mental component scores versus baseline.

Topics: Acute Disease; Adult; Aged; Anti-Bacterial Agents; Azithromycin; Bronchitis, Chronic; Female; Humans; Male; Middle Aged; Prospective Studies; Quality of Life; Surveys and Questionnaires; Time Factors; Treatment Outcome

Acute otitis media (AOM) is a common childhood infection that is frequently treated by antibiotics. There are no prospective and comprehensive trials evaluating childhood AOM for etiologic pathogens and resistance pattern in Turkey. The aims of the study were to determine the bacterial etiologies and resistance patterns, and identify the efficacy and the relapse rates of 3 days of azitromycin and 10 days of cefaclor therapy in AOM.. This prospective, randomized, single-blind, open study was carried out in 78 cases of AOM. Mean age was 30.7+/-27 months. Tympanocentesis and aspiration of middle ear fluid (MEF) were used to obtain purulent material from the middle ear. Group 1 consisted of the cases (n=41) on azitromycin therapy and Group 2 (n=37) on cefaclor. Dosage of azitromycin was 10 mg/kg per day for 3 days and cefaclor 40 mg/kg per day for 10 days. The patients were evaluated on days 3-5 (second visit), day 10 (third visit), and day 30 (fourth visit) during follow-up.. A total of 50 species were isolated from 44 of 78 cases from which materials were obtained (44/78; 56.4%). Most frequently isolated microorganism was Streptococcus pneumoniae (n=18; 36%), followed by Haemophilus influenzae (n=11; 22%), S. aureus (n=9; 18%), Moraxella catarrhalis (n=4; 8%), and group A beta-hemolytic streptococcus (GAS, n=4; 8%). Enterococcus faecalis was isolated from three cases and H. parainfluenzae from one. Penicillin and amoxicillin resistances of bacteria were found to be 40 and 36%, respectively. The frequency of penicillin and amoxicillin resistance in

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Cefaclor; Child; Child, Preschool; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Otitis Media; Prospective Studies; Single-Blind Method; Time Factors

To compare the safety and efficacy of oral azithromycin and levofloxacin in the treatment of outpatients with acute bacterial exacerbations of chronic bronchitis (ABECB).. Randomized, double-blinded, double-dummy, multicenter trial with 1:1 treatment allocation.. Outpatient treatment setting.. Two hundred thirty-five male or female outpatients between the ages of 35 and 75 years who had received a clinical diagnosis of ABECB.. Blinded treatment with either oral azithromycin, 500 mg on day 1 and 250 mg per day for days 2 to 5, or, oral levofloxacin, 500 mg q24h for 7 days.. Both treatments were well-tolerated, with the majority of adverse events being GI in nature. Favorable clinical outcomes in clinically evaluable patients were demonstrated in 89% of patients receiving azithromycin and in 92% of patients receiving levofloxacin by day 4 of therapy. At day 24, the posttherapy visit, favorable responses were approximately 82% and 86%, respectively, for patients in the two treatment groups. The bacterial eradication rates of respiratory pathogens were 96% for azithromycin and 85% for levofloxacin.. Despite increasing concerns over macrolide resistance and a higher incidence of Gram-negative pathogens, a standard 5-day course of oral azithromycin was clinically and bacteriologically equivalent to a 7-day course of oral levofloxacin in the treatment of patients with ABECB.

Topics: Acute Disease; Adult; Aged; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin; Bacterial Infections; Bronchitis, Chronic; Double-Blind Method; Female; Humans; Levofloxacin; Logistic Models; Male; Middle Aged; Multivariate Analysis; Ofloxacin

The effectiveness and costs of azithromycin and cefoperazone treatment of COPD exacerbation have been analysed in this study. Forty patients at the mean age of 65.9 (+/- 11.5) years were enrolled. The subjects were randomly selected and treated either with cefoperazone 2 x 1.0 g i.v. daily (group I = 20 persons) or with azithromycin 1 x 0.5 g (group II = 20 persons), in sequential method. Body temperature, cough intensity, quality and quantity of expectorated sputum, number of breaths per minute and adverse events were recorded daily. The values of pulmonary function tests and leucocytosis were assessed three times during the study. Statistically significant differences between both groups have been found with respect to the mean time of staying in hospital (9.1 days--group I vs 6.1 days--group II), mean total duration of antibiotic therapy (10.1 days--group I vs. 6.6 days--group II) and duration of intravenous antibiotic therapy only [7.5 days (group I) vs 2.9 days (group II)] (p < 0.05). Taking into account the duration of hospitalization, it was shown that the mean total costs of treatment of COPD exacerbation with azithromycin was significantly lower than that of treatment with cefoperazone (2375.9 PLN and 1663.7 PLN, respectively) (p < 0.05).. The effectiveness of treatment with azithromycin in patients with COPD exacerbation was evident. The total costs of treatment of COPD exacerbation with azithromycin is lower than with cefoperazone. Both azithromycin and cefoperazone are safe in the treatment of exacerbation of COPD.

Topics: Acute Disease; Adult; Aged; Anti-Bacterial Agents; Azithromycin; Cefoperazone; Chi-Square Distribution; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Double-Blind Method; Drug Costs; Female; Humans; Length of Stay; Male; Middle Aged; Poland; Pulmonary Disease, Chronic Obstructive; Respiratory Function Tests; Time Factors; Treatment Outcome

Short-term use of antibiotics has become a common component of the management of acute exacerbations of chronic bronchitis (AECB), particularly in complex cases with productive cough or purulent phlegm. The macrolide antibiotics, particularly second-generation agents such as dirithromycin and azithromycin, are among the antibiotic classes frequently recommended and used to treat upper and lower respiratory infections, including AECB.. This study compared the clinical efficacy and tolerability of 5-day courses of dirithromycin and azithromycin given once daily for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD).. This randomized, investigator-blinded, parallel-group clinical trial was conducted at 5 centers in the United States. Eligible patients were adult (age >35 years) smokers or ex-smokers (smoking history of at least 10 pack-years) with chronic bronchitis and an acute exacerbation, defined by the occurrence of increased dyspnea and/or productive cough and feverishness within 48 hours of enrollment. Before randomization, an attempt was made to obtain a sputum specimen from each patient for Gram's staining and culture. Patients were randomized to receive dirithromycin 500 mg QD for 5 days or azithromycin 500 mg QD on day 1 and 250 mg QD on days 2 to 5. Clinical efficacy was assessed separately by patients and physicians at early (days 7-10) and late (days 25-35) posttreatment visits.. Eighty-six patients (48 women, 38 men; mean age, 55 years) with a mean smoking history of 31 pack-years were included in the intent-to-treat analysis. Forty-six (54%) patients were randomized to dirithromycin and 40 (47%) patients to azithromycin. Clinical efficacy was reported in a high proportion of patients in both treatment groups, both at the early posttreatment visit (84.8% dirithromycin, 75.7% azithromycin; difference dirithromycin - azithromycin, 9.1%; 95% CI, -8.2 to 26.4) and the late posttreatment visit (95.5% and 86.5%, respectively; difference dirithromycin - azithromycin, 9.0%; 95% CI, -3.7 to 21.6). A similar proportion of patients required a second course of antibiotics over the study period (20.5% dirithromycin, 27.0% azithromycin; difference dirithromycin - azithromycin, -6.6%; 95% CI, -25.2 to 12.1). Only 42 (48.8%) patients were able to produce a sputum sample before receiving study treatment, and of these, only 20 (47.6%) demonstrated a preponderance of neutrophils on Gram's staining. Both treatments were well tolerated.. The results of this study suggest comparable clinical efficacy between 5-day courses of once-daily dirithromycin and azithromycin in acute exacerbations of COPD. There were insufficient data to permit meaningful comparison of the bacteriologic efficacy of these macrolide antibiotics.

Topics: Acute Disease; Administration, Oral; Anti-Bacterial Agents; Azithromycin; Drug Administration Schedule; Erythromycin; Female; Humans; Macrolides; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Single-Blind Method; Time Factors; Treatment Outcome

The pharmacokinetics of azithromycin (Zitromax), Pfizer Inc., USA) in tonsil tissue warranted the present trial. In 110 patients eligible for tonsillectomy because of recurrent acute tonsillitis, surgery was replaced by randomized medication with azithromycin 500 mg or placebo once per week for 6 months. Subsequently, their clinical condition and microbiology was monitored for 12 months. Acute tonsillitis developed in 40% of the patients who received azithromycin and in 49% of the patients in the placebo group (P > 0.05). Accordingly, 45% of all patients developed acute tonsillitis. Resistance to azithromycin was not detected. In this trial long-term medication with azithromycin was not efficacious in recurrent acute tonsillitis. As all patients were eligible for tonsillectomy according to current criteria, it is surprising that only 45% developed acute tonsillitis during the trial period. Therefore, the criteria for tonsillectomy in recurrent acute tonsillitis must be revised.

Topics: Acute Disease; Adolescent; Adult; Anti-Bacterial Agents; Azithromycin; Child; Female; Humans; Male; Middle Aged; Recurrence; Tonsillitis; Treatment Failure

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

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

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

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

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

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

Infection with Helicobacter pylori and Chlamydia pneumoniae is associated with coronary heart disease. We conducted an intervention study using antibiotics against these bacteria in patients with acute coronary syndromes to determine whether antibiotics reduce inflammatory markers and adverse cardiac events.. Patients (n=325) admitted with acute myocardial infarction or unstable angina (acute coronary syndromes) were randomized to receive a 1-week course of 1 of 3 treatment regimens: (1) placebo; (2) amoxicillin (500 mg twice daily), metronidazole (400 mg twice daily), and omeprazole (20 mg twice daily); or (3) azithromycin (500 mg once daily), metronidazole (400 mg twice daily), and omeprazole (20 mg twice daily). Serum fibrinogen, white cell count, and high-sensitivity C-reactive protein were measured at study entry and at 1, 3, and 12 months during follow-up. Cardiac death and readmission with acute coronary syndrome were considered clinical end points. Patients were followed for 1 year. C-reactive protein levels were reduced (P=0.03) in unstable angina patients receiving amoxicillin, and fibrinogen was reduced in both patient groups receiving antibiotics (P=0.06). There were 17 cardiac deaths and 71 readmissions with acute coronary syndrome. No difference in frequency or timing of end points was observed between the 2 antibiotic groups. At 12 weeks, there was a 36% reduction in all end points in patients receiving antibiotics compared with placebo (P=0.02). This reduction persisted during the 1-year follow-up. Neither C pneumoniae nor H pylori antibody status was significantly related to response to treatment.. Antibiotic treatment significantly reduced adverse cardiac events in patients with acute coronary syndromes, but the effect was independent of H pylori or C pneumoniae seropositivity.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin; Angina, Unstable; Anti-Bacterial Agents; Antibodies, Bacterial; Azithromycin; Biomarkers; Chlamydophila Infections; Chlamydophila pneumoniae; Disease-Free Survival; Double-Blind Method; Female; Helicobacter Infections; Helicobacter pylori; Humans; Inflammation; Male; Middle Aged; Myocardial Infarction; Syndrome

A minority of patients with upper respiratory tract infections (URTI) have a bacterial infection and may benefit from antibiotherapy. In previous investigations we showed that in patients suffering from acute rhinosinusitis associated with the presence of Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis in their nasopharygeal secretions, resolution of symptoms was significantly improved by antibiotic treatment. The present analysis was performed to determine whether specific clinical symptoms or signs observed during careful endoscopic examination of the nasal cavities could help the clinician to identify a subset of patients with moderate forms of acute rhinosinusitis infected with pathogenic bacteria. Detailed clinical histories were obtained and medical examinations performed in 265 patients (138 females, 127 males; mean age 35 years) presenting with a < 4-week history of URTI symptoms but who did not require immediate antibiotic therapy for severe rhinosinusitis. The presence of three pathogenic bacteria (S. pneumoniae, H. influenzae and M. catarrhalis) was determined in all patients by culture of nasopharyngeal secretions. Azithromycin (500 mg/day for 3 days; n = 133) or placebo (n = 132) were randomly given to all patients in a double-blind manner. Pathogenic bacteria were found in 77 patients (29%). The clinical signs and symptoms significantly associated in a multivariate model with the presence of bacteria included colored nasal discharge (p < 0.003), facial pain (p < 0.032) and radiologically determined maxillary sinusitis (complete opacity, air-fluid level or mucosal thickening > 10 mm) (p < 0.001). This best predictive model had a sensitivity of 69% and a specificity of 64% and therefore could not be used either as a screening tool or as a diagnostic criterion for bacterial rhinosinusitis. In the group of patients with positive bacterial cultures, resolution of symptoms at Day 7 was observed in 73% of patients treated with azithromycin and in 47% of patients in the placebo group (p < 0.007). We conclude that signs and symptoms of acute rhinosinusitis in patients with mild-to-moderate clinical presentations are poor predictors of the presence of bacteria.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Azithromycin; Double-Blind Method; Endoscopy; Female; Haemophilus influenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Predictive Value of Tests; Prospective Studies; Radiography; Sinusitis; Streptococcus pneumoniae

Prior use of antibiotics is associated with carriage of resistant bacteria. Colonization by Streptococcus pneumoniae, Haemophilus influenzae, nonpneumococcal alpha-hemolytic streptococci (NPAHS), and Staphylococcus aureus was evaluated in children receiving antibiotic therapy for acute otitis media and in untreated, healthy control subjects. Children were randomly assigned to receive either amoxicillin/clavulanate (90 mg/kg per day) or azithromycin. Swabs were obtained before initiating therapy and again 2 weeks and 2 months after initiating therapy. We also obtained swabs from control subjects at the time of enrollment and 2 weeks and 2 months after enrollment. The decrease in the rate of carriage of S. pneumoniae and H. influenzae at 2 weeks was significant only in the amoxicillin/clavulanate group (P<.001 and P=.005, respectively). The rate of nasopharyngeal colonization with NPAHS among treated patients increased from 23% to 39% at 2 months (P=.01). This increase was similar for both treatment groups. These results suggest that the competitive balance between organisms is altered by antibiotic therapy.

Topics: Acute Disease; Amoxicillin; Azithromycin; Bacterial Infections; Child, Preschool; Clavulanic Acid; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Infant, Newborn; Male; Nasopharyngeal Diseases; Otitis Media; Serotyping; Staphylococcus aureus; Streptococcus; Streptococcus pneumoniae

The value of azithromycin for treatment of acute bronchitis is unknown, even though this drug is commonly prescribed. We have investigated this question in a randomised, double-blind, controlled trial.. Adults diagnosed with acute bronchitis, without evidence of underlying lung disease, were randomly assigned azithromycin (n=112) or vitamin C (n=108) for 5 days (total dose for each 1.5 g). All individuals were also given liquid dextromethorphan and albuterol inhaler with a spacer. The primary outcome was improvement in health-related quality of life at 7 days; an important difference was defined as 0.5 or greater. Analysis was by intention to treat.. The study was stopped by the data-monitoring and safety committee when 220 patients had been recruited. On day 7, the adjusted difference in health-related quality of life was small and not significant (difference 0.03 [95% CI -0.20 to 0.26], p=0.8). 86 (89%) of 97 patients in the azithromycin group and 82 (89%) of 92 in the vitamin C group had returned to their usual activities by day 7 (difference 0.5% [-10% to 9%], p>0.9). There were no differences in the frequency of adverse effects; three patients in the vitamin C group discontinued the study medicine because of perceived adverse effects, compared with none in the azithromycin group. Most patients (81%) reported benefit from the albuterol inhaler.. Azithromycin is no better than low-dose vitamin C for acute bronchitis. Further studies are needed to identify the best treatment for this disorder.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anti-Bacterial Agents; Ascorbic Acid; Azithromycin; Bronchitis; Chi-Square Distribution; Double-Blind Method; Female; Humans; Male; Middle Aged; Quality of Life; Surveys and Questionnaires; Treatment Outcome

Acute respiratory tract infection (ARTI) is the commonest reason for which antibiotics are prescribed, despite the fact that ARTI is mostly of viral origin. The effectiveness of antibiotics in these illnesses is, at best, questionable. Jordan is a developing country where bacterial infections are thought to be more common than in developed countries and initially viral illnesses are frequently superimposed by bacterial infections. The present study represents an attempt to assess whether routine antibiotic treatment of ARTI has any beneficial effect on the course of the illness. The study was conducted in northern Jordan between 1 June and December 14, 2000. Patients > or =8 y of age visiting either of 2 health centers and diagnosed by the physician with ARTI above the level of the bronchioles were assigned on an alternating basis to receive either azithromycin or placebo. Patients were assessed at their initial visit and were subsequently followed up after 3 d, 1 week and 2 weeks. A total of 185 patients were included in the study. Patients administered azithromycin or placebo did similarly in terms of the proportions improved or cured and the duration of illness. We conclude that routine use of antibiotics (azithromycin) in ARTI is unlikely to alter the course of the illness.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Child; Female; Humans; Male; Middle Aged; Patient Compliance; Respiratory Tract Infections; Treatment Outcome

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

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

To compare the outcome of patients with recurrent acute otitis media (AOM) treated either with amoxicillin or with azithromycin.. This prospective, controlled, and randomized study, compares the outcome of 71 patients with recurrent AOM treated with azithromycin (31 patients) or amoxicillin (40 patients) for the prevention of AOM. azithromycin was given at a dose of 10 mg/kg once a week, whereas amoxicillin was administered daily as a single intake of one third of the therapeutic dosage (20 mg/kg per day). All treatments were prescribed for 3 months. Both groups were homogeneous with regard to the currently accepted predisposing factors of recurrent AOM. Mean age of children was 35.3 months, and average follow-up was 11.5 months. The treatment was considered effective when the number of episodes of AOM dropped to less than 50% after the prophylaxis.. Patients in the azithromycin group had a clinical response to prophylaxis (80.6%) comparable to those treated with amoxicillin (89.5%) (P=0.300). The incidence of adverse effects was similar in both groups.. According to these results, a prophylaxis with azithromycin is as useful as amoxicillin to prevent recurrent AOM.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Penicillins; Probability; Prospective Studies; Reference Values; Secondary Prevention; Treatment Outcome

The aim of the present study was to assess the hypothesis that, when present in nasopharyngeal secretions, Streptococcus pneumoniae. Haemophilus influenzae, and Moraxella catarrhalis play a pathogenic role early in the course of an upper respiratory tract infection. Adults with a clinical diagnosis of acute sinusitis or common cold were enrolled. Participants were randomly assigned in a double-blind manner to receive azithromycin 500 mg daily or placebo for 3 days. The effect of treatment on symptom evolution in the predefined subset of patients with Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis in their nasopharyngeal secretions was assessed. Of 265 patients enrolled, 132 received placebo and 133 azithromycin. Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis was identified in nasopharyngeal secretions of 77 patients (29%). In this predefined subgroup of patients with Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, resolution of symptoms by day 7 occurred in 73% of those treated with azithromycin compared with 47% of those who received placebo (P=0.007). The median time before resolution of symptoms was 5 days in the azithromycin group compared to 7 days in the placebo group. Respiratory complications requiring antibiotic treatment occurred in 19% of patients in the placebo group and in 3% of the azithromycin group (P=0.025). In the remaining 188 patients without Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, resolution of symptoms by day 7 was similar in both groups (69% in the placebo group vs. 64% in the azithromycin group [P=0.75]). Antibiotic treatment is of clinical benefit for patients with acute sinusitis or common cold when Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis is present in nasopharyngeal secretions. This observation provides new insights into the pathogenic role of these bacteria in the early stage of the common cold.

Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Azithromycin; Common Cold; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Haemophilus influenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Nasopharynx; Reference Values; Respiratory Tract Infections; Sinusitis; Streptococcus pneumoniae; Treatment Outcome

One hundred ninety-two female patients with acute urethral syndrome caused by Ureaplasma urealyticum were examined. First, patients were divided into two groups: those with clinical symptoms present for less than 3 weeks before the start of treatment and those with clinical symptoms 3 weeks or longer before the beginning of therapy. The patients were then further divided into groups and randomized to receive azithromycin once daily in a single dose of 1 g or 500 mg once daily for 6 days, or to receive doxycycline 100 mg b.i.d. for 14 days or 100 mg b.i.d. for 7 days (eight study groups in all). Clinical and bacteriological efficacy were evaluated 3 weeks after the end of therapy. In the group of patients with disease symptoms lasting for 3 weeks or longer, eradication and clinical cure rates were significantly higher after the administration of azithromycin at a dose of 1 x 500 mg/6 days than after a single dose of 1 g (p < 0.001).

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Bacterial Agents; Azithromycin; Doxycycline; Female; Humans; Middle Aged; Syndrome; Time Factors; Treatment Outcome; Ureaplasma Infections; Ureaplasma urealyticum; Urethral Diseases

A prospective, open-label, randomized study was conducted in order to determine the bacteriologic efficacies of cefaclor and azithromycin in acute otitis media (AOM). Tympanocentesis was performed on entry into the study and 3 to 4 days after initiation of treatment. Bacteriologic failure after 3 to 4 days of treatment with both drugs occurred in a high proportion of culture-positive patients, especially in those in whom AOM was caused by Haemophilus influenzae (16 of 33 [53%] of those treated with azithromycin and 13 of 34 [52%] of those treated with cefaclor). Although a clear correlation of the persistence of the pathogen with increased MICs of the respective drugs could be demonstrated for Streptococcus pneumoniae, no such correlation was found for H. influenzae. It is proposed that susceptibility breakpoints for H. influenzae should be considerably lower than the current ones for both cefaclor and azithromycin for AOM caused by H. influenzae.

Topics: Acute Disease; Administration, Oral; Anti-Bacterial Agents; Azithromycin; Cefaclor; Child, Preschool; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Prospective Studies; Streptococcus pneumoniae

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

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

The effect of antibiotic therapy on nasopharyngeal colonization by Streptococcus pneumoniae and Haemophilus influenzae was evaluated in children diagnosed with acute otitis media. Children were randomly assigned to receive either amoxicillin/clavulanate or azithromycin therapy, and nasopharyngeal swabs were obtained for culture before and after starting therapy. Amoxicillin/clavulanate therapy eradicated or suppressed all strains of S. pneumoniae susceptible to penicillin, 75% of strains with intermediate resistance, and 40% of strains resistant to penicillin. Azithromycin therapy cleared two-thirds of azithromycin-susceptible strains of S. pneumoniae but none of azithromycin-nonsusceptible strains. Selection for antibiotic-resistant strains in individual children was not observed in children who received amoxicillin/clavulanate therapy but was observed in 2 children who received azithromycin therapy. Carriage of H. influenzae was also reduced by antimicrobial therapy but more so by amoxicillin/clavulanate. Antibiotic therapy does not directly increase the number of resistant strains in the population but, by eradicating susceptible strains, allows greater opportunity for carriage and spread of resistant strains.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Carrier State; Child; Child, Preschool; Clavulanic Acid; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Nasopharynx; Otitis Media; Pneumococcal Infections; Streptococcus pneumoniae

Chronic bronchitis is common among adults and infectious exacerbations contribute considerably to morbidity and mortality. We aimed to compare the safety and efficacy of moxifloxacin to azithromycin for the treatment of patients with acute exacerbations of chronic bronchitis (AECB) of suspected bacterial origin. Between October 1998 and April 1999, 567 patients with AECB were enrolled at 37 centers across the United States and Canada of which 280 (49%) had acute bacterial exacerbation of chronic bronchitis (i.e. pretherapy pathogen). Patients were randomized to either oral moxifloxacin 400 mg administered once daily for 5 days or azithromycin for 5 days (500 mg qd x 1, then 250 mg qd x 4). For the purpose of study blinding, all patients received encapsulated tablets. The main outcome measure was clinical response at the test-of-cure visit (14-21 days post-therapy). Secondary measures included bacteriologic response and a time-course of bacteriological eradication (one center only). Three patient populations were analysed for efficacy: clinically-valid, microbiologically-valid (i.e. those with a pretherapy pathogen), and intent-to-treat (i.e. received at least one dose of study drug). For the efficacy-valid group, clinical response at the test-of-cure visit was 88% for patients in each treatment group. In 237 microbiologically-valid patients, corresponding clinical resolution rates were 88% for 5-day moxifloxacin vs. 86% for 5-day azithromycin. Bacteriological eradication rates at the end of therapy were 95% for 5-day moxifloxacin and 94% for the azithromycin group. Corresponding eradication rates at the test-of-cure visit were 89% and 86%, respectively. Of note, eradication rates at test-of-cure for Haem. philos influenzae and H. parainfluenzae for moxifloxacin were 97% and 88% compared to 83% and 62% respectively for azithromycin. Among 567 intent-to-treat patients (283 moxifloxacin and 284 azithromycin), drug-related events were reported for 22% and 17%, respectively. Diarrhea and nausea were the most common drug-related events reported in each treatment group. Moxifloxacin 400 mg once daily for 5 days was found to be clinically and bacteriologically equivalent to 5-day azithromycin for the treatment of AECB of proven bacterial etiology. Given its excellent in-vitro activity, especially against antibiotic-resistant respiratory pathogens, and its acceptable safety profile, moxifloxacin should be considered an effective alternative therapy for patients wi

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Infective Agents; Aza Compounds; Azithromycin; Bacterial Infections; Bronchitis; Chronic Disease; Double-Blind Method; Female; Fluoroquinolones; Humans; Male; Middle Aged; Moxifloxacin; Multicenter Studies as Topic; Prospective Studies; Quinolines

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Bacterial Agents; Azithromycin; Doxycycline; Female; Humans; Microbial Sensitivity Tests; Middle Aged; Treatment Outcome; Ureaplasma Infections; Ureaplasma urealyticum; Urethral Diseases

The aim of this study was to determine the potential influence of variables such as the cell content in the fluid, and serum levels, on the concentrations of ceftibuten, cefixime and azithromycin in the middle ear fluid of patients suffering from acute otitis media.. This randomized, open study compared the penetration of ceftibuten (9 mg kg(-1) 18 patients), cefixime (8 mg kg(-1), 16 patients) and azithromycin (10 mg kg(-1) 16 patients) into the intracellular and extracellular compartments of middle ear fluid of 50 paediatric patients (aged 8-14 years) with acute otitis media. Middle ear fluid was extracted by tympanocentesis 4, 12 and 24 h after dosing and divided into two fractions: with cells (as collected) (C+) and cell-free (C-). Antibiotics were assayed in C+ and C- samples by h.p.l.c.. Ceftibuten achieved greater penetration into middle ear fluid than cefixime and azithromycin. Higher concentrations of ceftibuten (CTB) and cefixime (CFX) were found in the C- fraction (CTB: 4h 13.3+/-1.86; 12h 4.7+/-1.18; 24h 0.5+/-0.2. CFX: 4h 3.2+/-1.4; 12h 1.5+/-0.5; 24h>(0.1 mgl(-1)) than in the C+ fraction (CTB:4 h 8.4+/-4.3; 12 h 2.88+/-1.19; 24 h 0.3+/-0.27. CFX: 4 h 1.2+/-0.6; 12 h 0.8+/-0.2; 24 h>0.1 mg l(-1)) at the each time point, while the opposite was true for azithromycin (C-: 4 h 0.11+/-0.04; 12 h 0.12+/-0.08; 24 h 0.23+/-0.12. C+: 4 h 0.38+/-0.24; 12 h 0.9+/-0.03; 24 h 1.05+/-0.3 mg l(-1)).. This study demonstrates that the penetration of antibiotics into the middle ear fluid is influenced by its serum concentrations as well as by the cell content in the fluid. Ceftibuten achieved higher middle ear fluid concentrations than cefixime in C+ and C- fractions at all time points. Both ceftibuten and cefixime concentrations are negatively influenced by the cell content in the fluid. In contrast the concentration of azithromycin to the middle ear fluid is positively influenced by the cell content in the fluid.

Topics: Acute Disease; Administration, Oral; Adolescent; Anti-Bacterial Agents; Azithromycin; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Child; Exudates and Transudates; Female; Humans; Male; Otitis Media with Effusion; Time Factors

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

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

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

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

A comparison was made of the clinical effectiveness of azithromycin (once daily for three days at a dose of 10 mg/kg in children or 500 mg/day in adults) and amoxicillin/clavulanic acid and cefaclor (standard doses for 7 to 14 days) in acute ear, nose and throat infections in an open randomized study. The group with azithromycin included 37 otitis media, 24 pharyngotonsillitis and 6 maxillary sinusitis (n = 67). The amoxicillin/clavulanic acid group, 22 otitis media, 19 pharyngotonsillitis and 6 maxillary sinusitis (n = 47) and the cefaclor group, 15 otitis media, 12 pharyngotonsillitis and 4 maxillary sinusitis (n = 31). Fifteen days after beginning treatment, 97% (65/67) of the patients who received azithromycin had improved or cured, compared with 85% (40/47) of those who received amoxicillin/clavulanic acid and 84% (26/31), cefaclor (p < 0.02). Pathogens were not eradicated in 3% (2/58) of the patients who received azithromycin, compared with 13% (4/28) who received amoxicillin/clavulanic acid and 15% (4/28) cefaclor. Patients with azithromycin showed an earlier clinical improvement and more rapid normalization of the leukocyte count, erythrocyte sedimentation rate and acute phase proteins. No patient with azithromycin had adverse effects, versus 15% (7/47) for patients with amoxicillin/clavulanic acid and 16% (5/31) for cefaclor. Treatment compliance was 100, 83 (39/47) and 84% (26/31), respectively (p < 0.01). We conclude that azithromycin treatment for three days is faster and more effective clinically and analytically than standard treatment with amoxicillin/clavulanic acid or cefaclor in acute infections of the ear, nose and throat.

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Azithromycin; Cefaclor; Cephalosporins; Clavulanic Acid; Female; Humans; Male; Maxillary Sinusitis; Otitis Media; Penicillins; Pharyngitis; Tonsillitis

To determine the relation between early bacteriologic eradication and clinical outcome of acute otitis media (AOM) in infants and young children treated with various antibiotics.. The study group consisted of patients ages 3 to 24 months seen at the Pediatric Emergency Room with: (1) symptoms and physical findings consistent with AOM of < or = 7 days duration; (2) no spontaneous perforation or tympanostomy tubes; (3) positive initial middle ear fluid culture; and (4) a follow-up to at least Day 10+/-2 of the study with a second culture performed 72 to 96 h after initiation of antibiotic treatment. Any patient with a positive middle ear fluid culture 72 to 96 h after initiation of antibiotic treatment was considered to have bacteriologic failure. Otologic evaluation was done by an otolaryngologist unaware of the culture results and of the study drug allocation. A clinical score based on body temperature, report of irritability and ear tugging observed by the parents and the appearance and redness of the ear drum as observed by the otolaryngologist was also used for clinical evaluation.. The study group consisted of 123 patients, of whom 57 (46%) had positive middle ear fluid 72 to 96 h after initiation of antibiotic treatment. Clinical failure was observed in 21 of 57 (37%) patients in whom bacteriologic eradication did not occur vs. only 2 of 66 (3%) patients with bacteriologic eradication after 3 to 4 days of treatment (P < 0.001). Clinical score for both moderate and severe disease decreased significantly faster in those with bacteriologic eradication than in those in whom middle ear fluid was still culture-positive 72 to 96 h after initiation of treatment.. Clinical failures in our population were associated with inability to eradicate the causative organisms of AOM from the middle ear fluid within 3 to 4 days after initiation of antibiotic therapy. Most patients (including those without bacteriologic eradication) improved after 3 to 4 days of treatment, but patients with sterile middle ear fluid felt better after 3 to 4 days of treatment than patients in whom middle ear fluid was still culture-positive.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Bacteria; Cefaclor; Cephalosporins; Child, Preschool; Female; Humans; Infant; Male; Otitis Media with Effusion; Penicillins; Prospective Studies; Treatment Outcome

In vitro study of the antibacterial activity of macrolide antibiotics azitromycin (sumamed), midicamycin (macropen), roxitromycin (rulide), and erythromycin demonstrated their high activity towards clinical strains of bacteroids, fusobacteria, peptostreptococci, streptococci, and corynebacteria. These antibiotics were effective in the treatment of 62 adult patients with severe and moderate generalized periodontitis. Rulide and sumamed were the most effective, macropen and erythromycin were inferior to them.

Topics: Acute Disease; Adolescent; Adult; Anti-Bacterial Agents; Antifungal Agents; Azithromycin; Chronic Disease; Drug Therapy, Combination; Erythromycin; Humans; Leucomycins; Middle Aged; Nystatin; Periodontitis; Roxithromycin

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Azithromycin; Clarithromycin; Drug Interactions; Female; Humans; Male; Neutropenia; Rifabutin

In an open-label study, the concentrations of azithromycin in middle ear effusions and plasma were determined in 29 children between 1 and 8 years of age with a diagnosis of either secretory otitis media of at least 1 month's duration or acute otitis media. Azithromycin (10 mg/kg) was administered as a single dose 12, 24 or 48 h before the insertion of tympanostomy tubes to 17 children with secretory otitis media and once daily for 5 days (10 mg/kg on day 1, 5 mg/kg on days 2-5) to 12 children with acute otitis media. In the 16 evaluable patients with secretory otitis media, azithromycin penetrated middle ear effusions, with group mean concentrations approximately two orders of magnitude greater than the concurrent plasma concentrations 12, 24 and 48 h after administration. Similar plasma:effusion ratios were found 24 and 48 h after starting once-daily therapy in 10 evaluable patients with acute otitis media.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Ear, Middle; Female; Humans; Infant; Male; Otitis Media with Effusion; Otitis Media, Suppurative

An open, multicentre study involving 259 children between 6 months and 13 years of age was performed to assess the efficacy and safety of azithromycin and to compare it with cefaclor as treatment of acute otitis media. Patients were randomized to receive either azithromycin 10 mg/kg once daily for 3 days or cefaclor 40 mg/kg daily in divided doses every 8 h for 10 days. Cure or improvement in signs and symptoms was observed in 112/114 (98%) evaluable azithromycin-treated patients and 116/120 (97%) evaluable cefaclor-treated patients on days 11-15. In contrast to cefaclor, however, azithromycin was associated with a significantly (P = 0.033) higher cure rate 1 month after completion of treatment. In those patients who were followed up to days 25-30, the response was satisfactory (cure or improvement) in 31/32 (97%) patients who had received azithromycin and in 31/36 (86%) to whom cefaclor had been administered. Patients tolerated both treatments well and no severe adverse events related to therapy were recorded in either group. The results of this study show that a 3-day, once-daily regimen of azithromycin has comparable clinical efficacy and tolerability to a thrice-daily course of cefaclor administered for 10 days, but the azithromycin is associated with a lower incidence of relapse.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Cefaclor; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Otitis Media

Azithromycin and cefaclor were compared for the treatment of acute otitis media, streptococcal pharyngitis/tonsillitis, or sinusitis in an open multicentre study conducted in 530 adults. At the end of therapy (day 11-15), 228/245 (93%) patients treated with azithromycin 500 mg once daily for 3 days and 233/241 (97%) treated with cefaclor 250 mg given three times daily for 10 days were considered to have responded satisfactorily (cured or improved). In bacteriologically evaluable patients with pharyngitis/ tonsillitis, Streptococcus pyogenes was eradicated in 116/117 (99%) azithromycin- and in 115/119 (97%) cefaclor-treated patients at day 11-15; one patient in each group had become reinfected after initial eradication of the pathogen. When followed up on day 25-30, S. pyogenes infection had recurred in 5/105 (5%) azithromycin and 4/108 (3%) cefaclor patients who had responded satisfactorily at day 11-15, and whose baseline pathogen had been eradicated. Of these patients, two in the azithromycin and one in the cefaclor group also relapsed clinically; the others remained asymptomatic. Patients tolerated both treatments well; treatment-related adverse events were recorded in 11% of the 267 azithromycin- and 10% of the 263 cefaclor-treated patients assessed for safety. One azithromycin patient and five cefaclor patients withdrew because of adverse events. The results of the study show that a 3-day regimen of azithromycin, given once daily, is as effective and well tolerated as a multiple-daily, 10-day cefaclor regimen for the treatment of upper respiratory tract infections in adults.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Cefaclor; Cephalosporins; Female; Humans; Male; Middle Aged; Respiratory Tract Infections

An open, multicentre study was undertaken in order to evaluate the efficacies and safety profiles of azithromycin and roxithromycin in 440 adults with acute otitis media, sinusitis or acute beta-haemiolytic streptococcal pharyngitis/tonsillitis. Treatment with 500 mg azithromycin, administered orally once daily for 3 days, produced a satisfactory clinical outcome (cure or improvement) in 51/52 (98%) patients with otitis media, 91/91 (100%) patients with pharyngitis/tonsillitis and 64/68 (94%) patients with sinusitis. Treatment with 150 mg roxithromycin, given orally twice daily for 10 days, produced satisfactory clinical responses in 54/55 (98%), 91/92 (99%) and 69/73 (94%) patients with otitis media, pharyngitis/tonsillitis and sinusitis respectively. Of the 17 azithromycin-treated patients with sinusitis who were clinically and bacteriologically evaluable, Staphylococcus aureus persisted in two and Streptococcus pneumoniae in one. S. aureus also persisted in 1/12 clinically and bacteriologically-evaluable patient treated with roxithromycin. Of the 58 and 64 patients with pharyngitis/tonsillitis treated with azithromycin and roxithromycin, respectively, who were clinically and bacteriologically evaluable, Streptococcus pyogenes persisted at the end of treatment in 7/58 (12%) in the azithromycin group and in 13/64 (20%) in the roxithromycin group. At follow-up, there was no evidence of S. pyogenes reinfection in patients treated with azithromycin. Three episodes of reinfection occurred in the roxithromycin treatment group. Also, three patients showed evidence of clinical relapse at follow-up, although no pathogens were isolated. Azithromycin was associated with a lower incidence of adverse events. No azithromycin-treated patient was withdrawn prematurely because of a treatment-related event. Three roxithromycin-treated patients were withdrawn from treatment because of severe headache, thyroiditis or fatigue. In conclusion, for adults with acute upper respiratory tract infections, a 3-day course of once-daily azithromycin was found to be as effective and as well tolerated as a 10-day course of twice-daily roxithromycin.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Female; Humans; Male; Middle Aged; Recurrence; Respiratory Tract Infections; Roxithromycin

In an open, multicentre study, the clinical and bacteriological efficacy, safety and tolerance of azithromycin and roxithromycin were compared in a total of 204 adults with acute lower respiratory tract infections (LRTIs) [acute bronchitis, acute infectious exacerbations of chronic bronchitis (AIECBs), or pneumonia]. Following treatment with 500 mg/day azithromycin administered orally once daily for 3 days, a satisfactory clinical response of cure or improvement was recorded in 91/99 (91.9%) evaluable patients at the post-therapy evaluation (day 10-14). Of the 94 evaluable patients treated with roxithromycin (150 mg given orally twice daily for 10 days), 82 (87.2%) were classified as cured or improved at post-therapy. The main pathogens isolated before treatment were Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus species, Haemophilus influenzae and Moraxella catarrhalis. In the 46 azithromycin-treated patients evaluated both clinically and bacteriologically, 92.0% of pathogens were eradicated; H. influenzae persisted in one azithromycin-treated patient with acute bronchitis who was classed as clinically improved. In the roxithromycin group, 81.1% of the pathogens were eradicated in 35 patients; S. aureus persisted in one clinically cured patient with acute bronchitis, and H. influenzae persisted in one patient with AIECB and one with pneumonia, and Haemophilus species in one with AIECB, who were all classified as clinically improved. Azithromycin was well tolerated with a lower incidence of adverse events than that recorded in the roxithromycin treatment group. Treatment was not discontinued due to adverse events in any of the azithromycin-treated patients, whereas two roxithromycin-treated patients were withdrawn from treatment due to vomiting and/or dyspepsia.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Female; Humans; Male; Middle Aged; Respiratory Tract Infections; Roxithromycin; Treatment Outcome

An open, multicentre study was carried out in 200 paediatric patients between 6 months and 12 years of age with skin and/or soft tissue infections (mild-to-moderate dermatological conditions and abscesses) to compare the efficacy and safety of azithromycin and cefaclor oral suspensions. Patients were randomly assigned to receive either azithromycin (10 mg/kg once daily for 3 days) or cefaclor (20 mg/kg/day in three divided doses for 10 days). The clinical efficacy of both treatments was comparable: 92/98 (94%) of the evaluable azithromycin patients were cured or improved as were 93/98 (95%) of those treated with cefaclor. Before treatment, 74 pathogens were isolated from 60 of the azithromycin- and 80 pathogens from 66 of the cefaclor-treated patients. In the azithromycin group, 70/74 (95%) pathogens were eradicated, as were 79/80 (99%) pathogens in the cefaclor group. All 200 patients were evaluable for safety analyses. Both drugs were well tolerated, with a low incidence of side-effects: 3/100 (3%) in the azithromycin group and 2/100 (2%) in the cefaclor group. No patient in either treatment group withdrew from the study because of adverse events. In conclusion, azithromycin is as effective and as well tolerated as cefaclor in the treatment of children with skin and/or soft tissue infections.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Cefaclor; Cephalosporins; Child; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Skin Diseases, Infectious; Soft Tissue Infections

The economic impacts in terms of cost and effectiveness (speed of resolution of symptoms) of 3- and 5-day courses of azithromycin and a 10-day course of roxithromycin were compared in a randomized, open study in patients with symptoms suggestive of beta-haemolytic streptococcal pharyngitis. Direct medical costs and absence from work were recorded and symptom scores and compliance were used to assess the effectiveness of therapies. Although no differences between treatment groups in terms of overall clinical response rates were detected 2 and 4 weeks after the start of treatment, more rapid resolution of symptoms was achieved with 3- and 5-day courses of azithromycin than with a 10-day course of roxithromycin. There was also a significant reduction in the time absent from work in the azithromycin treatment groups. The total costs of care over the 4-week evaluation period were lower for the 3- and 5-day azithromycin courses (US$193.60 and US$195.30 respectively) than for roxithromycin (US$202.10). The major cost components were absence from work (58.6%), visits to the physician (15.3%) and utilization of antibiotics (14.9%). Compliance was significantly better (P < 0.01) in patients prescribed azithromycin for 3 and 5 days (58.0% and 42.9% respectively) than in those who received roxithromycin (20.3%) and a significantly longer symptom-free period (P < 0.01) was reported in azithromycin- compared with roxithromycin-treated patients. These findings support the hypothesis that a 3- or 5-day course of azithromycin is as effective as a 10 day course of roxithromycin in the treatment of patients with pharyngitis and is associated with lower costs. Furthermore, azithromycin is associated with faster resolution of symptoms and improved patient compliance.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Bacterial Agents; Azithromycin; Cost-Benefit Analysis; Female; Humans; Male; Middle Aged; Patient Compliance; Pharyngitis; Prospective Studies; Roxithromycin; Socioeconomic Factors; Treatment Outcome

For many years alternatives to penicillin have been studied for the management of pediatric group A beta-hemolytic Streptococcus (GABHS) pharyngitis. As a result of its pharmacokinetic profile azithromycin is unique among these alternative antimicrobials in allowing once daily dosing and shorter duration of treatment. However, the optimum dose (e.g. 10 or 12 mg/kg/day) and duration (e.g. 3 or 5 days) of azithromycin therapy have not been defined yet.. An open, comparative multicenter study was conducted in 343 children with clinical symptoms of GABHS pharyngitis and a positive culture to evaluate the efficacy and safety of azithromycin (10 mg/kg) once daily for 3 days compared with penicillin V three times daily for 10 days.. Among the evaluable patients bacteriologic eradication documented at follow-up visits was inferior with azithromycin when compared with penicillin V therapy: at Days 9 to 20 (mean, 12 days), negative cultures in 65% (99 of 152 patients) vs. 82% (128 of 126 patients) (P < 0.001); and at Days 17 to 57 (mean, 25 days), in 55% vs. 80% (P < 0.001). Overall clinical success (cure or improvement) was achieved in 93% (149 of 160 patients) of azithromycin-treated and in 89% (143 of 160 patients) of penicillin-treated patients (P > 0.50). There was no correlation between bacteriologic response and clinical outcome, as assessed shortly after completion of therapy or during 6-month follow-up. Both treatments were well-tolerated.. In the present study on GABHS pharyngitis in children, a once daily (10-mg/kg), 3-day oral regimen of azithromycin was as clinically effective and as safe as traditional penicillin but appeared inferior in eliminating GABHS from the throat.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Female; Humans; Infant; Male; Penicillin V; Penicillins; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes

In this multicenter, open label trial the investigators evaluated the efficacy and safety of azithromycin suspension administered once daily for 5 days for the treatment of clinically and bacteriologically established acute otitis media.. Two hundred eligible children with acute otitis media from 10 US centers were treated with 10 mg/kg of azithromycin oral suspension on Day 1, followed by 5 mg/kg once daily for the next 4 days. Tympanocentesis and subsequent culture of middle ear effusion were performed at baseline. Clinical efficacy was evaluated on Days 6, 11 and 30.. Analysis of clinical efficacy in evaluable patients 11 days after the initiation of therapy showed that the rate of satisfactory responses (cured or improved) ranged from 79.6 to 82.4% in patients infected with Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. Satisfactory clinical response at Day 30 was reported in 70% of evaluable patients, and eradication of S. pneumoniae, H. influenzae and M. catarrhalis was presumed in 64 to 73%. Relapses occurred in 14% of the evaluable patients. Among the treated patients 8.5% reported mild or moderate side effects.. Azithromycin is an effective, safe and well-tolerated treatment for children with acute otitis media.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Drug Administration Schedule; Female; Haemophilus Infections; Humans; Male; Moraxella catarrhalis; Neisseriaceae Infections; Otitis Media; Pneumococcal Infections

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

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

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

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

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

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

In the treatment of acute maxillary sinusitis, azithromycin offers an advantage over phenoxymethylpenicillin in that a complete course of treatment requires drug administration once daily for only three days. In this double-blind, parallel-group, multicenter study, 438 patients with radiographically verified maxillary sinusitis were randomly assigned to receive either 500 mg azithromycin once daily for three days (221 patients) or 1.3 g phenoxymethylpenicillin three times daily for ten days (217 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia, were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 51% in the penicillin group; after 25 days the cure rate was 79% versus 76%, respectively. When both cure and improvement were considered, the corresponding figures after 11 days were 97% (azithromycin) and 95% (penicillin); after 25 days they were 92% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 73 (33%) of the azithromycin-treated patients and in 87 (40.1%) of those treated with penicillin. No difference in efficacy was found between the two drugs in the treatment of acute maxillary sinusitis, and the adverse effects were comparable. The short duration of treatment with azithromycin offers a significant advantage over treatment with phenoxymethylpenicillin.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Bacterial Agents; Azithromycin; Chi-Square Distribution; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Maxillary Sinusitis; Middle Aged; Penicillin V; Penicillins; Treatment Outcome

The objective of our study was to characterize the pharmacokinetics of azithromycin after the oral administration of multiple doses in suspension to children with acute otitis media. Thirteen children (ranging in age from 7.5 months to 5 years) received a single oral dose of 10 mg of azithromycin per kg of body weight on day 1 followed by single daily doses of 5 mg/kg on days 2 to 5. Each child fasted overnight before receiving the final dose on day 5. Multiple blood samples were collected after the last dose. Concentrations of azithromycin in serum were measured by a specific high-performance liquid chromatography-mass spectrometry method. The means and standard deviations for the maximum concentration of azithromycin in serum, the time to maximum concentration of azithromycin in serum, the area under the concentration-time curve (from 0 to 24 h), and the elimination half-life were 224 +/- 120 ng/ml, 1.8 +/- 0.4 h, 1,841 +/- 651 ng.h/ml, and 31.6 +/- 6.6 h, respectively. Concentrations in serum (means +/- standard deviations) at 0 h (predose) and at 24, 48, and 72 h after the final dose were 51 +/- 26, 47 +/- 21, 27 +/- 17, and 17 +/- 13 ng/ml, respectively. Thus, the once-daily administration of azithromycin resulted in sustained systemic exposure to the drug. The drug dosage regimen used in this study should lead to tissue drug concentrations exceeding the MICs for common pathogens.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child, Preschool; Female; Humans; Infant; Male; Mass Spectrometry; Otitis Media

The aim of this study is to find out the efficacy and safety of azithromycin in the treatment of males with uncomplicated non-gonococcal urethritis. It is an open, non-comparative study carried out in the major sexually transmitted disease clinics in Hong Kong. The subjects were 45 male outpatients with clinical symptoms and signs of acute non-gonococcal urethritis. Patients presenting with acute urethritis were examined and non-gonococcal urethritis were examined and non-gonococcal urethritis was daignosed by the positive urethral smear for white blood cells but negative for gonococcus. They were given a single 1 gram oral dose of azithromycin at the clinic. Follow-ups after one and two weeks to examine for cure and adverse events were made. The result showed that 35 out of 42 evaluable patients were cleared of urethritis. Only 2 out of 22 chlamydial antigen positive patients still remained positive at the last visit. Adverse events were not uncommon but all were only mild. We concluded that 1 gram single dose of azithromycin was effective and well tolerated in the treatment of non-gonococcal urethritis in male patients.

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Azithromycin; Chlamydia Infections; Follow-Up Studies; Hong Kong; Humans; Male; Middle Aged; Pilot Projects; Sexually Transmitted Diseases, Bacterial; Urethritis

A multicenter open prospective comparative study was carried out during two years enrolling 60 patients with upper respiratory infections. Thirty were treated with single daily 500 mg doses of azithromycin for three days, and 30 received two daily doses of roxithromycin of 150 mg each for seven days. Both treatments were equally well tolerated, and there was no substantial difference concerning clinical recovery. However, azithromycin treatment was more practical and of shorter duration.

Topics: Acute Disease; Adolescent; Adult; Azithromycin; Female; Humans; Male; Middle Aged; Respiratory Tract Infections; Roxithromycin

Clinical efficacy of azithromycin and erythromycin was compared in an open trial in 32 and 18 patients with acute sinusitis respectively. The following pathogens were isolated: Haemophilus influenzae (29.8 per cent), Streptococcus pneumoniae (19.1 per cent), Staphylococcus aureus (10.6 per cent), Streptococcus faecalis (8.5 per cent) and other microbes (8.5 per cent). Azithromycin was administered in a dose of 500 mg on day 1. During the following 4 days it was administered in a dose of 250 mg. Erythromycin was administered in a dose of 500 mg 4 times a day for 8 to 10 days. 91.2 per cent of the aerobic microflora were sensitive to azitromycin and 85.3 per cent were sensitive to erythromycin. One of 14 strains of H. influenzae proved to be resistant to azithromycin, 3 strains were resistant to erythromycin. Complete recovery was stated in 90.6 per cent of the cases treated with azithromycin and 66.7 per cent of the cases treated with erythromycin.

Topics: Acute Disease; Adult; Azithromycin; Drug Resistance, Microbial; Erythromycin; Female; Humans; Male; Sinusitis

A prospective study was conducted to evaluate azithromycin in combination with pyrimethamine for treatment of acute Toxoplasma encephalitis in patients with AIDS. Of the 14 patients given 75 mg pyrimethamine and 500 mg azithromycin daily for four weeks, eight were evaluable for clinical response. Five responded favorably, one had an intermediate response and two an unfavorable response. Of the nine patients evaluable for radiological response, six responded favorably, and three had an intermediate response. Eleven adverse events occurred in nine patients: rash (n = 5), abnormal liver function (n = 2), vomiting (n = 3) and hypoacousia (n = 1). This pilot study suggests that the combination of pyrimethamine and azithromycin may be further investigated and that the optimal dosage of azithromycin has yet to be determined.

Topics: Acute Disease; Adult; AIDS-Related Opportunistic Infections; Azithromycin; Drug Administration Schedule; Drug Therapy, Combination; Encephalitis; Female; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Pyrimethamine; Sulfadiazine; Toxoplasmosis, Cerebral

The aim of this prospective, blinded, randomized study was to demonstrate the efficacy and safety of oral azithromycin and dicloxacillin in the treatment of adults with acute skin and skin-structure infections. Sixty-two patients were included in the intent-to-treat group and 60 were evaluable for analysis. Azithromycin was given as a 500 mg once-daily dose for three days and dicloxacillin as 250 mg qid for seven days. Isolated pathogens included primarily Staphylococcus aureus, Streptococcus spp., and coagulase-negative staphylococci. Clinical resolution was 83.3% in the azithromycin group and 83.9% in the dicloxacillin group, with bacteriological eradication of 90.0% in the azithromycin group and 87.1% in the dicloxacillin group. Persistence of infection was recorded in one patient in the dicloxacillin group and superinfection in one patient in the azithromycin group. Azithromycin appears to be a safe and effective antibiotic for the treatment of adult patients with acute skin and skin-structure infections.

Topics: Abscess; Acute Disease; Adolescent; Adult; Azithromycin; Dicloxacillin; Double-Blind Method; Drug Administration Schedule; Erythromycin; Female; Humans; Male; Middle Aged; Prospective Studies; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Staphylococcus aureus; Streptococcus

The efficacy and safety of azithromycin and clarithromycin were compared in an open multicentre study involving 380 adult patients with acute otitis media, acute sinusitis, or acute streptococcal pharyngitis or tonsillitis. Patients were assigned randomly to receive azithromycin as a single dose of 500 mg daily for three days, or clarithromycin 250 mg bid for ten days. Overall clinical efficacy was found to be similar in each treatment group at day 10-14, with a satisfactory outcome (cured or improved) in 95% of azithromycin and 96% of clarithromycin patients. Bacteriological efficacy was also similar, with eradication of the pathogen in 94% and 95% of isolates, respectively, in the azithromycin and clarithromycin groups. In otitis media, a satisfactory clinical response was seen in 97% of patients in each treatment group. Azithromycin therapy resulted in a clinical response rate of 93% in sinusitis patients, with bacteriological eradication in 93% of patients. Two patients (who were cured clinically) had persistent pathogens. Similarly, clarithromycin achieved clinical response and bacteriological eradication in 95% and 92% of sinusitis patients, respectively. Pathogens persisted in two patients with clinical cure, and in one case of clinical failure. In pharyngitis or tonsillitis, Streptococcus pyogenes was eradicated successfully in 95% of patients in both groups, and the clinical success rates were 96% and 97% for azithromycin and clarithromycin, respectively. No case of clinical failure was associated with persistence of S. pyogenes infection. At the follow-up assessment of this diagnosis group, reinfection had occurred in three (8%) azithromycin patients and one (3%) clarithromycin patient, and all but one patient remained asymptomatic. Both drugs were well-tolerated, with 8.4% of patients on azithromycin and 7.4% on clarithromycin reporting adverse events, mainly gastrointestinal. It was concluded that a three-day course of azithromycin was as effective and well-tolerated as a ten-day course of clarithromycin in adults with acute upper respiratory tract infections.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Azithromycin; Bacterial Infections; Child; Clarithromycin; Drug Administration Schedule; Erythromycin; Escherichia coli Infections; Female; Humans; Male; Middle Aged; Otitis Media; Pharyngitis; Respiratory Tract Infections; Sinusitis; Staphylococcal Infections; Staphylococcus aureus; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

The efficacy and safety of azithromycin and clarithromycin in lower respiratory tract infection (LRTI) were compared in an open, multicentre study. Five hundred and ten adult patients with a diagnosis of LRTI, including acute bronchitis, acute infective exacerbations of chronic bronchitis (AIECB) or pneumonia were enrolled. The patients were randomly assigned to receive either azithromycin (n = 252) as a single daily dose of 500 mg for three days, or clarithromycin (n = 258) 250 mg twice daily for ten days. In AIECB patients, baseline comparisons of the two treatment groups showed that there were no differences in the number of previous episodes of infection or in the incidence of current or past smokers. The overall clinical efficacy was found to be similar in each treatment group on day 10 to 14, with a satisfactory response (cured or improved) in 94% of azithromycin- and 97% of clarithromycin-treated patients. At follow-up evaluation (day 18 to 22), 97% of azithromycin- and 100% of clarithromycin-treated patients who had improved at day 10 to 14, showed satisfactory outcomes. Bacteriological efficacy was similar in both treatment groups, with eradication of 100% vs 95% of isolates in the azithromycin and clarithromycin groups, respectively. In AIECB, 100% of pathogens were eradicated by azithromycin, although one patient was clinically assessed as failed. Clarithromycin eradicated 93% of pathogens in this group; all patients being assessed as cured or improved. Both drugs were well tolerated, with 9% and 6% of patients reporting adverse events with azithromycin and clarithromycin, respectively. These adverse events were largely gastrointestinal in origin. It was concluded that a three-day course of azithromycin is as effective and well tolerated as a ten-day course of clarithromycin in adults with acute LRTIs.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Azithromycin; Bacterial Infections; Bronchitis; Clarithromycin; Drug Administration Schedule; Erythromycin; Female; Humans; Male; Middle Aged; Pneumonia; Respiratory Tract Infections

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

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

In this open study, a three-day regimen of azithromycin (single daily dose of 10 mg/kg) was compared with a ten-day regimen of amoxycillin paediatric suspension (30 mg/kg/day in three divided doses; children > 20 kg received 250 mg tid daily) in 154 children (aged 2-12 years) with a clinical diagnosis of acute otitis media (13 recurrent). Full clinical, bacteriological and laboratory safety assessments were performed during and after the study. Of the 77 azithromycin patients, 61 (79%) were considered cured, 15 (19%) improved and one (1%) failed, compared with 45 (58%) cured, 28 (36%) improved and four (5%) failed among the 77 amoxycillin patients. Excluding from analysis the 13 patients with recurrent otitis media, azithromycin was found to be significantly superior to amoxycillin (P = 0.003). The incidence of side-effects was low, with only two (3%) and three (4%) patients reporting adverse events with azithromycin and amoxycillin, respectively. These were gastrointestinal in nature and of mild or moderate severity, except for one case of severe diarrhoea in the amoxycillin group. No treatment-related abnormalities in the laboratory safety tests were observed, and no patients withdrew from therapy. A three-day regimen of azithromycin was therefore shown to be more effective than, and as well tolerated as, amoxycillin in the treatment of children with acute otitis media.

Topics: Acute Disease; Amoxicillin; Azithromycin; Bacterial Infections; Child; Child, Preschool; Drug Administration Schedule; Erythromycin; Female; Humans; Male; Otitis Media; Respiratory Tract Infections

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

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

Of 96 children (aged 2-12 years) with either acute pharyngitis or acute tonsillitis, 49 received a single daily dose of azithromycin 10 mg/kg (maximum 500 mg) for three days, and 47 received penicillin V at a dose of 125 mg or 250 mg qid (depending on body weight) for ten days. Clinical assessments and laboratory safety tests were performed during and after therapy. Before enrollment, all patients were screened for group A beta-haemolytic streptococci (GABHS) with a rapid test, and a throat swab was taken for confirmatory culture. The presence of GABHS at baseline was confirmed in 41 azithromycin- and 44 penicillin V-treated patients. Cure or improvement was seen in 98% and 100% of azithromycin- and penicillin V-treated patients, respectively. At day 11, bacterial eradication was achieved in 39/41 (95%) azithromycin-treated patients, 38 (93%) of whom were considered clinically cured, while one patient (2%) relapsed. In the penicillin V group, 42/44 (95%) had GABHS eradicated, with 41 (93%) clinically cured and three patients (7%) improved. The remaining two patients in each group were clinically cured despite persistence of Streptococcus pyogenes. At follow-up evaluation (day 30), re-occurrence was observed in 5/37 (14%) and 3/40 (8%) of azithromycin- and penicillin V-treated patients, respectively; all patients were asymptomatic. Both drugs were well-tolerated with only two patients in the azithromycin group complaining of side effects. Treatment related laboratory test abnormalities were observed in 6/47 (13%) and 4/45 (9%) azithromycin- and penicillin V-treated patients, respectively, but none was judged to be clinically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Azithromycin; Child; Child, Preschool; Erythromycin; Female; Humans; Male; Penicillin V; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

In this open study, 93 children (aged 2-12 years) with a clinical diagnosis of pharyngitis or tonsillitis caused by Streptococcus pyogenes (culture and/or ELISA test positive) were given azithromycin, as a single daily dose of 10 mg/kg (maximum 500 mg) for three days (n = 46); or erythromycin ethylsuccinate, 30-50 mg/kg daily given in three divided doses, for ten days (n = 47). Forty-four of 46 azithromycin patients, and 46 of 47 erythromycin patients, had S. pyogenes isolated at baseline and were included in the clinical and bacteriological analyses. At the end of treatment (day 10-12), 38 (86%) of the 44 azithromycin patients were considered cured, four (9%) improved, one (2%) failed and one relapsed. In the erythromycin group, 30 of 46 (65%) were considered cured, 15 (33%) improved and one (2%) failed. Eradication of S. pyogenes was achieved in 40 of 44 (91%) and 45 of 46 (98%) azithromycin and erythromycin patients, respectively. Re-occurrence of S. pyogenes, assessed 28-32 days after start of treatment, occurred in five of 37 (14%) azithromycin patients (three with clinical symptoms) and five of 39 (13%) erythromycin patients (four with clinical signs). There were no statistically significant differences in clinical or bacteriological efficacy between the two groups. Both drugs were well-tolerated, with side-effects (mainly gastrointestinal) reported in five of 46 (11%) azithromycin patients and in six of 47 (13%) erythromycin patients, one of whom withdrew from treatment. No laboratory abnormalities were observed in the azithromycin patients, but were recorded in two of 43 (5%) erythromycin patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Azithromycin; Child; Child, Preschool; Drug Administration Schedule; Erythromycin; Female; Humans; Male; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

The efficacy and tolerability of azithromycin and erythromycin in the treatment of acute respiratory tract infections in children were compared in an open, multicenter, randomized trial. A total of 151 children, aged from 2 months to 14 years, suffering from upper airways infections (60), or lower respiratory tract infections (91), were randomized to be treated either with azithromycin, 10 mg/Kg/day per os once daily for 3 or 10 mg/Kg/day 1 and 5 mg/Kg/days 2-5 (77 patients) or with erythromycin, 50 mg/Kg/day thrice daily for at least 7 days (74 patients). The two treatment groups did not significantly differ as to sex, age, weight, type and severity of infection, and infecting pathogens. Clinical evaluation was performed prior to therapy, on treatment days 1, 3, 5 and 7, and on day 10. Microbiological and laboratory assessment were carried out at baseline and after the end of therapeutic course. Chest X-ray and serologic assays for Mycoplasma pneumoniae infection were obtained in patients suspected to have lower respiratory tract infections. At the end of therapy, clinical cure was achieved in 73 out of 77 patients (94.8%) in the azithromycin group, and in 60/72 evaluable subjects (83.3%) in the erythromycin group. A significantly more rapid remission of several illness-related signs and symptoms was observed in patients treated with azithromycin. A total of 75 bacterial pathogens were isolated at baseline microbiological examination; at the end of the therapeutic course bacteriological eradication was obtained in 34/34 cases (100%) treated with azithromycin, and in 40/41 children (97.5%) treated with erythromycin.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Azithromycin; Bacterial Infections; Child; Child, Preschool; Drug Administration Schedule; Erythromycin; Female; Humans; Infant; Male; Respiratory Tract Infections; Treatment Outcome

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

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

Seventy-eight patients participated in this multicenter, third-party-blinded study comparing a single daily dose of azithromycin for 5 days (500 mg on day 1 followed by 250 mg/day for days 2-5) with amoxicillin (500 mg three times daily) for 10 days in the treatment of acute bacterial maxillary sinusitis. A total of 38 evaluable patients contributed to the efficacy analysis. The overall clinical response rate was 100% for both antibiotics. The clinical cure rate, as determined by the investigator, was 73.9% for azithromycin and 73.3% for amoxicillin; improvement was seen in 26.1% and 26.7% of patients, respectively. The bacteriologic cure rate in these 38 patients was 100% in both groups. Both antibiotics were well tolerated; side effects were reported by 4.9% of patients in the azithromycin group compared with 8.1% in the amoxicillin group. Most of these side effects were gastrointestinal disturbances that were reported by four of five (three amoxicillin, one azithromycin) patients experiencing side effects. All side effects were mild, and in both groups only minor abnormalities in laboratory data were detected. No patient discontinued the study because of treatment-related side effects. In this study, a 5-day course (one dose per day) of azithromycin proved to have efficacy, safety, and tolerability that was equal to a 10-day course (three doses per day) of amoxicillin in the treatment of acute bacterial sinusitis.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin; Azithromycin; Erythromycin; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Maxillary Sinusitis; Middle Aged; Staphylococcal Infections; Streptococcal Infections

In this randomised, double-blind study carried out in 28 centres, azithromycin (500 mg single dose on day 1, followed by 250 mg once-daily on days 2-5) was compared with cefaclor (500 mg t.i.d. for 10 days) in the treatment of acute bacterial pneumonia. A total of 119 patients entered the study, and of these 71 were evaluable and included in the efficacy analysis. The overall satisfactory clinical response was 97.3% for azithromycin patients and 100% for cefaclor patients. The clinical cure rates of azithromycin and cefaclor were 46.9% and 41.0%, respectively; improvement was seen in an additional 46.9% of azithromycin-treated patients and in 59.0% of the cefaclor group. The bacteriological eradication rates were 80.4% and 92.6%, respectively. These rates of clinical and bacteriological efficacy, were not statistically different. Both antibiotics were well tolerated during the study; only two patients (one on each study drug) discontinued medication due to adverse events. The overall incidence of side effects was 18.9% (10 of 53 patients) for azithromycin- and 12.1% (eight of 66 patients) for cefaclor-treated patients. Gastrointestinal disturbances were the most commonly reported side effects (nine of 10 azithromycin-treated patients and six of eight cefaclor-treated patients). In addition, two cefaclor patients reported headache. All azithromycin side effects were mild or moderate in severity, but there were two severe occurrences in the cefaclor group (1 nausea, 1 vomiting) the later leading to discontinuation.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Azithromycin; Bacterial Infections; Cefaclor; Double-Blind Method; Drug Administration Schedule; Erythromycin; Female; Humans; Male; Middle Aged; Pneumonia

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

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

The over prescription of antibiotics for acute respiratory infections is a major public health problem worldwide.. To evaluate the frequency of prescription of antibiotics for non-pneumonia acute respiratory infections in private outpatient clinics in individuals without chronic diseases or immunosuppression.. All medical records of adult consultants in a national network of private ambulatory medical centers during May 2018 whose primary diagnosis corresponded to acute respiratory infections not pneumonia (ICD10) were identified and retrospectively analyzed, excluding those with chronic respiratory conditions or states of immunosuppression.. Of the 38,072 consultants (aged 36 years, 63% women) who met this criterion, 54% (n = 20,499) received a prescription for at least one antibiotic. The diagnoses that most frequently received this prescription were acute bronchitis (28.7%), acute sinusitis (16.5%) and acute tonsillitis (16.2%). The most frequently prescribed antibiotic globally was azithromycin (37.4%), followed by amoxicillin (20.1%) and amoxicillin plus clavulanic acid (17.7%). Levofloxacin prescription reached 12.5% of total prescriptions.. An antibiotic was prescribed in more than half of the non-pneumonia outpatient acute respiratory infections. Azithromycin was the most prescribed antibiotic, while levofloxacin exceeded 10% of prescriptions. These results reinforce the need to implement an antibiotic prescription surveillance system at the outpatient level.

Topics: Acute Disease; Adult; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Drug Prescriptions; Female; Humans; Levofloxacin; Male; Outpatients; Practice Patterns, Physicians'; Respiratory Tract Infections; Retrospective Studies

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Campylobacter Infections; Campylobacter jejuni; Colchicine; Diarrhea; Electrocardiography; Female; Foodborne Diseases; Humans; Magnetic Resonance Imaging; Middle Aged; Myocarditis; Pericarditis; Troponin I; Tubulin Modulators

Topics: Acute Disease; Anti-Bacterial Agents; Autoimmune Diseases; Azithromycin; Behavior Therapy; Child; Diagnosis, Differential; Humans; Male; Obsessive-Compulsive Disorder; Penicillins; Streptococcal Infections

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Antimalarials; Azithromycin; Betacoronavirus; Coronavirus Infections; COVID-19; Drug Therapy, Combination; Humans; Hydroxychloroquine; Male; Meningoencephalitis; Pandemics; Pneumonia, Viral; SARS-CoV-2

A patient with COVID-19-related severe respiratory failure, with insufficient response to an antiretroviral therapy, hydroxychloroquine and Interleukin-6 (IL-6) antagonist therapy, presented a prompt resolution of the respiratory function and improvement in the radiological picture after baricitinib at an oral dose of 4 mg per day for 2 weeks.

Topics: Acute Disease; Aged; Antibodies, Monoclonal, Humanized; Antiviral Agents; Azetidines; Azithromycin; Betacoronavirus; Coronavirus Infections; COVID-19; Drug Combinations; Drug Repositioning; Humans; Hydroxychloroquine; Lopinavir; Male; Pandemics; Pneumonia, Viral; Purines; Pyrazoles; Respiratory Insufficiency; Ritonavir; SARS-CoV-2; Sulfonamides; Treatment Outcome

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Azithromycin; Betacoronavirus; Coronavirus Infections; COVID-19; Female; Humans; Pancreatitis; Pandemics; Pneumonia, Viral; SARS-CoV-2; Sinusitis

Fulminant macrolide-resistant Mycoplasma pneumoniae pneumonia (MPP) has seldom been reported, and cases of MPP usually show rapid improvement after fluoroquinolones or tetracyclines addition. The purpose of this case report is to highlight the importance of proper selection of antibiotics for treatment of severe MPP and increase awareness concerning the emergence of fluoroquinolone-resistant MPP.. A case of severe life-threatening pneumonia in a 26-year-old man with high fever and cough was non-responsive to azithromycin and fluoroquinolones.. The patient was diagnosed with MPP based on the test results of bronchoalveolar lavage using real-time quantitative PCR method.. Tigecycline was given to the patient after azithromycin and fluoroquinolones failed.. The patients fever subsided within the first day of tigecycline therapy. He showed rapid symptom resolution and improvement in lung infiltration after 4 days of tigecycline therapy.. The case suggests that fulminant MPP should be timely treated with proper antibiotics, and the possible emergence of fluoroquinolone-resistant MPP should be of concern.

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Azithromycin; Brochothrix; Drug Resistance, Bacterial; Fluoroquinolones; Humans; Male; Mycoplasma pneumoniae; Pneumonia, Mycoplasma; Tigecycline; Tomography, X-Ray Computed

Neisseria meningitidis sequence type 11 is an emerging cause of urethritis. We demonstrate by using whole-genome sequencing orogenital transmission of a N. meningitidis sequence type 11 isolate causing urethritis in a monogamous couple of men who have sex with men. These results suggest dissemination of this clonal complex among low-risk patients.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Communicable Diseases, Emerging; Humans; Injections, Intramuscular; Male; Meningococcal Infections; Neisseria meningitidis; Sexual and Gender Minorities; Sexually Transmitted Diseases; Treatment Outcome; Urethritis; Whole Genome Sequencing; Young Adult

We analyzed the 23S rRNA, gyrA and parC genes of Chlamydia trachomatis DNAs from men with urethritis and determined microbiological outcomes of an extended-release azithromycin (azithromycin-SR) regimen (2 g once daily for 1 day) and a sitafloxacin regimen (100 mg twice daily for 7 days) for chlamydial urethritis to clarify the macrolide and fluoroquinolone resistance status of clinical strains of C. trachomatis. We amplified the portions of 2 alleles of the 23S rRNA gene and the gyrA and parC genes from C. trachomatis DNAs in 284 first-voided urine specimens from men with chlamydial urethritis by PCR and sequenced their PCR products. We enrolled 369 men with chlamydial urethritis, comprising 314 and 55 treated with the azithromycin-SR regimen and the sitafloxacin regimen, respectively. Alleles 1 and/or 2 of the 23S rRNA gene were analyzed in 162 specimens. No mutations were found in the sequenced regions, including the central portion of domain V. The gyrA and parC genes were analyzed in 118 and 113 specimens, respectively. No amino acid changes were found within the quinolone resistance-determining region of the gyrA gene and in the sequenced region of the parC gene. The microbiological outcomes of the azithromycin-SR and sitafloxacin regimens were assessed in 176 and 30 men, respectively. The eradication rates were 96.0% (95% CI 93.1%-98.9%) for the azithromycin-SR regimen and 100% for the sitafloxacin regimen. Clinical strains of C. trachomatis with macrolide and/or fluoroquinolone resistance would be uncommon, and azithromycin or fluoroquinolone regimens could be recommended as treatments for chlamydial infections.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Chlamydia Infections; Chlamydia trachomatis; DNA Gyrase; DNA Mutational Analysis; DNA Topoisomerase IV; DNA, Bacterial; Drug Resistance, Bacterial; Fluoroquinolones; Humans; Male; RNA, Ribosomal, 23S; Treatment Outcome; Urethritis

Early-life use of antibiotics is associated with asthma. We examined the effect of antibiotic use for early-life bronchiolitis on the development of new-onset asthma in children from Taiwan between 2005 and 2010. Data were from the National Health Insurance Research Database 2010, and diseases were coded using the International Classification of Disease (ICD). We classified the patients, all of whom had bronchiolitis, as having asthma or not having asthma. Asthma was diagnosed using ICD criteria and by use of an inhaled bronchodilator and/or corticosteroid twice in one year. We identified age at asthma onset, sex, residential area, history of atopy and NSAID use, age at first use of antibiotics, and the specific antibiotic, and adjusted for these factors using conditional logistic regression analysis. Among all individuals, there was a relationship between risk of new-onset asthma with use of a high dose of an antibiotic (adjusted odds ratio [aOR] = 3.33, 95% confidence interval [CI] = 2.67-4.15). Among the different antibiotics, macrolides (aOR = 2.87, 95% CI = 1.99-4.16), and azithromycin specifically (aOR = 3.45, 95% CI = 1.62-7.36), had the greatest effect of development of asthma.

Topics: Acute Disease; Age Factors; Anti-Bacterial Agents; Asthma; Azithromycin; Bronchiolitis; Child, Preschool; Female; Humans; Macrolides; Male; Odds Ratio; Risk Factors; Taiwan

According to clinical trials, azithromycin taken daily for 1 year, decreased exacerbations of chronic obstructive pulmonary disease (COPD).. Effectiveness evaluation of long-term azithromycin to reduce exacerbations in severe COPD patient on optimal therapy in real-life practice.. We conducted a retrospective observational study of severe COPD patients who were prescribed azithromycin (PA)(250 mg, at least 3 times weekly for at least 6 months). Comparison group included severe COPD patients not prescribed azithromycin (NPA). Data were extracted from clinical chart review.. Study included 126 PA and 69 NPA patients. They had severe airflow obstruction, mostly emphysema and one-third bronchiectasis. A predominant feature in the PA group was respiratory tract colonization with Pseudomonas aeruginosa. The mean number of exacerbations per patient per year in the PA group was 3.2 ± 2.1 before initiating azithromycin, and 2.3 ± 1.6 during following year on therapy (p < 0.001). Patients in the NPA group had 1.7 ± 1.3 and 2.5 ± 1.7 exacerbations during first and second follow-up year respectively (p < 0.001). Exacerbation changes from pre to post differed between groups (p < 0.001). Decrease in emergency visits and hospital admissions was significant in PA group. Exacerbation reductions and patient proportions having ≥2 exacerbations extended to the second year of treatment.. These data showed that long-term azithromycin reduces exacerbation numbers in severe COPD patients, and benefits persist beyond one year. Desirable effects are more likely to outweigh the risks and adverse events in patients colonized with Pseudomonas aeruginosa.

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Bacterial Infections; Drug Administration Schedule; Female; Hospitalization; Humans; Male; Middle Aged; Patient Acceptance of Health Care; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Infections; Retrospective Studies; Smoking; Sputum

An 18-year-old woman presented to clinic with acute pharyngitis with 4/4 Centor criteria. Rapid streptococcal antigen test was negative. The patient, who was allergic to penicillin, was prescribed azithromycin. Ultimately, after 5 days and without any corticosteroids, she presented to the emergency department with 10/10 chest pain and was admitted to the intensive care unit. CT showed nodular lung disease and blood cultures on admission grew

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Chest Pain; Drug Resistance, Bacterial; Female; Fusobacterium; Fusobacterium Infections; Heart Arrest; Humans; Lemierre Syndrome; Pharyngitis

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Child; Humans; Infant; Otitis Media

Acute exacerbation (AE) of idiopathic pulmonary fibrosis (IPF) is a fatal condition without an established pharmaceutical treatment. Most patients are treated with high-dose corticosteroids and broad-spectrum antibiotics. Azithromycin is a macrolide with immunomodulatory activity and may be beneficial for treatment of acute lung injury. The objective of this study was to determine the effect of azithromycin on survival of patients with idiopathic AE of IPF.. We evaluated 85 consecutive patients hospitalized in our department for idiopathic AE of IPF from April 2005 to August 2016. The initial 47 patients were treated with a fluoroquinolone-based regimen (control group), and the following 38 consecutive patients were treated with azithromycin (500 mg/day) for 5 days. Idiopathic AE of IPF was defined using the criteria established by the 2016 International Working Group.. Mortality in patients treated with azithromycin was significantly lower than in those treated with fluoroquinolones (azithromycin, 26% vs. control, 70%; p < 0.001). Multivariate analysis revealed that the two variables were independently correlated with 60-day mortality as determined by the Acute Physiology and Chronic Health Evaluation II score (p = 0.002) and azithromycin use (p < 0.001).. Azithromycin may improve survival in patients with idiopathic AE of IPF.

Topics: Acute Disease; Aged; Aged, 80 and over; Anti-Bacterial Agents; APACHE; Azithromycin; Disease Progression; Female; Fluoroquinolones; Humans; Idiopathic Pulmonary Fibrosis; Male; Middle Aged; Retrospective Studies; Survival Rate; Symptom Flare Up

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Drug Eruptions; Female; Humans; Middle Aged; Tonsillitis

There have been few comprehensive studies on Haemophilus influenza-positive urethritis.. In this retrospective study, we enrolled 68 men with H. influenzae-positive urethritis, including coinfections with Neisseria gonorrhoeae, Chlamydia trachomatis, and/or genital mycoplasmas: 2, 3, 20, and 43 treated with ceftriaxone, levofloxacin, sitafloxacin, and extended-release azithromycin (azithromycin-SR), respectively. We assessed microbiological outcomes in 54 men and clinical outcomes in 46 with H. influenzae-positive monomicrobial nongonococcal urethritis. We determined minimum inhibitory concentrations (MICs) of 6 antimicrobial agents for 59 pretreatment isolates.. H. influenzae was eradicated from the men treated with ceftriaxone, levofloxacin, or sitafloxacin. The eradication rate with azithromycin-SR was 85.3%. The disappearance or alleviation of urethritis symptoms and the decreases in leukocyte counts in first-voided urine were significantly associated with the eradication of H. influenzae after treatment. For the isolates, ceftriaxone, levofloxacin, sitafloxacin, azithromycin, tetracycline, and doxycycline MICs were ≤0.008-0.25, 0.008-0.5, 0.001-0.008, 0.12-1, 0.25-16, and 0.25-2 μg/mL, respectively. The azithromycin MICs for 3 of 4 strains persisting after azithromycin-SR administration were 1 μg/mL. H. influenzae with an azithromycin MIC of 1 μg/mL increased chronologically.. H. influenzae showed good responses to the chemotherapies for urethritis. The significant associations of the clinical outcomes of the chemotherapies with their microbiological outcomes suggested that H. influenzae could play pathogenic roles in urethritis. All isolates, except for one with decreased susceptibility to tetracyclines, were susceptible to the examined agents. However, the increase in H. influenzae with an azithromycin MIC of 1 μg/mL might threaten efficacies of azithromycin regimens on H. influenzae-positive urethritis.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Chlamydia Infections; Chlamydia trachomatis; Coinfection; Doxycycline; Drug Resistance, Bacterial; Fluoroquinolones; Gonorrhea; Haemophilus influenzae; Humans; Leukocyte Count; Levofloxacin; Male; Microbial Sensitivity Tests; Neisseria gonorrhoeae; Retrospective Studies; Urethritis

Topics: Acute Disease; Administration, Oral; Anti-Bacterial Agents; Azithromycin; Child; Evidence-Based Medicine; Humans

Topics: Acute Disease; Animals; Azithromycin; Food Handling; Hand Dermatoses; Humans; Male; Middle Aged; Occupational Diseases; Staphylococcal Skin Infections; Staphylococcus; Treatment Outcome

An effective antibody response can assist drug treatment to contribute to better parasite clearance in malaria patients. To examine this, sera were obtained from two groups of adult patients with acute falciparum malaria, prior to drug treatment: patients who (1) have subsequent recrudescent infection, or (2) were cured by Day 28 following treatment. Using a Plasmodium falciparum antigen library, we examined the antibody specificities in these sera. While the antibody repertoire of both sera groups was extremely broad and varied, there was a differential antibody profile between the two groups of sera. The proportion of cured patients with antibodies against EXP1, MSP3, GLURP, RAMA, SEA and EBA181 was higher than the proportion of patients with recrudescent infection. The presence of these antibodies was associated with higher odds of treatment cure. Sera containing all six antibodies impaired the invasion of P. falciparum clinical isolates into erythrocytes. These results suggest that antibodies specific against EXP1, MSP3, GLURP, RAMA, SEA and EBA181 in P. falciparum infections could assist anti-malarial drug treatment and contribute to the resolution of the malarial infection.

Topics: Acute Disease; Adolescent; Adult; Antibodies, Neutralizing; Antibodies, Protozoan; Antibody Specificity; Antigens, Protozoan; Antimalarials; Artemether; Artemisinins; Azithromycin; Cohort Studies; Erythrocytes; Ethanolamines; Female; Fluorenes; Humans; Immune Sera; Immunity, Humoral; Lumefantrine; Malaria, Falciparum; Male; Plasmodium falciparum; Protozoan Proteins; Recurrence; Treatment Outcome

Acute diarrhea remains the serious problem in developing countries, especially among children under 5 years of age. Currently, only two or three common diarrhea pathogens were screened at most hospitals in China. The aim of this study was to provide a wide variety of diarrhea pathogens and their antimicrobial resistance patterns in children under 5 years of age.. Totally 381 stool samples collected from Tongji Hospital between July 1, 2014 and June 30, 2015 were tested by culture and/or polymerase chain reaction for eight kinds of bacteria and five kinds of viruses. An antimicrobial sensitivity test was performed using dilution method recommended by the Clinical and Laboratory Standards Institute.. Viral infections were mainly identified in infants (0-11 months), whereas bacterial infections were more prevalent in the age of 24-59 months. About 69.8% of samples were positive for at least one pathogen, 51.7% of samples were virus positive, followed by bacteria positive cases (19.4%), and 12.6% of cases displayed co-infections with two viruses or a virus and a bacterium. Rotavirus was the most prevalent pathogen, followed closely by norovirus, while Salmonella was the most commonly isolated bacteria, followed by diarrheagenic Escherichia coli (DEC) and Campylobacter. More than 40% of Salmonella spp. and DEC isolates were resistant to first-line antibiotics (ampicillin, trimethoprim-sulfamethoxazole, and tetracycline). Around 10% of Salmonella spp. isolates were resistant to ceftriaxone and ciprofloxacin simultaneously. Campylobacter spp. displayed high resistance to ciprofloxacin but kept low resistance to azithromycin and doxycycline.. The etiology of acute diarrhea varies in children of different age groups. The high frequency of infection with viruses suggests the urgent demand for new viral vaccine development. Proper use of antibiotics in the treatment of acute diarrhea is crucial due to the high level of antibiotic resistance.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Campylobacter; Child, Preschool; China; Ciprofloxacin; Diarrhea; Doxycycline; Escherichia coli; Female; Humans; Infant; Infant, Newborn; Male; Salmonella

Noninfectious lung injury and acute graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (allo-HCT) are associated with significant morbidity and mortality. Azithromycin is widely used in allogeneic HCT recipients for pulmonary chronic GVHD, although current data appear controversial. We induced GVHD and noninfectious lung injury in lethally irradiated B6D2F1 mice by transplanting bone marrow and splenic T cells from allogeneic C57BL/6 mice. Experimental groups were treated with oral azithromycin starting on day 14 until the end of week 6 or week 14 after transplantation. Azithromycin treatment resulted in improved survival and decreased lung injury; the latter characterized by improved pulmonary function, reduced peribronchial and perivascular inflammatory cell infiltrates along with diminished collagen deposition, and a decrease in lung cytokine and chemokine expression. Azithromycin also improved intestinal GVHD but did not affect liver GVHD at week 6 early after transplantation. At week 14, azithromycin decreased liver GVHD but had no effect on intestinal GVHD. In vitro, allogeneic antigen-presenting cell (APC)- dependent T cell proliferation and cytokine production were suppressed by azithromycin and inversely correlated with relative regulatory T cell (Treg) expansion, whereas no effect was seen when T cell proliferation occurred APC independently through CD3/CD28-stimulation. Further, azithromycin reduced alloreactive T cell expansion but increased Treg expansion in vivo with corresponding downregulation of MHC II on CD11c(+) dendritic cells. These results demonstrate that preventive administration of azithromycin can reduce the severity of acute GVHD and noninfectious lung injury after allo-HCT, supporting further investigation in clinical trials.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Azithromycin; Bone Marrow Transplantation; Cytokines; Dendritic Cells; Disease Models, Animal; Female; Graft vs Host Disease; Intestines; Liver; Lung; Lung Injury; Mice; Primary Cell Culture; Respiratory Function Tests; Spleen; Survival Analysis; T-Lymphocytes; Transplantation, Homologous; Whole-Body Irradiation

Megalocytic interstitial nephritis is a rare form of kidney disease caused by chronic inflammation. We report a case of megalocytic interstitial nephritis occurring in a 45-yrold woman who presented with oliguric acute kidney injury and acute pyelonephritis accompanied by Escherichia coli bacteremia. Her renal function was not recovered despite adequate duration of susceptible antibiotic treatment, accompanied by negative conversion of bacteremia and bacteriuria. Kidney biopsy revealed an infiltration of numerous histiocytes without Michaelis-Gutmann bodies. The patient's renal function was markedly improved after short-term treatment with high-dose steroid.

Topics: Acute Disease; Acute Kidney Injury; Anti-Bacterial Agents; Azithromycin; Bacteremia; Cefotaxime; Creatinine; Escherichia coli; Escherichia coli Infections; Female; Humans; Kidney; Methylprednisolone; Middle Aged; Nephritis, Interstitial; Pyelonephritis; Renal Dialysis; Shock, Septic

Gonococcal conjunctivitis is a rare infection induced by Neisseria gonorrhoeae and it usually manifests as a hyperacute purulent conjunctivitis. Ocular access of the infectious secretion during sexual intercourse is the way of transmission among adults. Inclusion conjunctivitis caused by the serovars D-K of Chlamydia trachomatis also affects the sexually active population. Authors present a case of a 33-year-old homosexual man who was treated for late latent syphilis formerly. Clinical symptoms were yellow purulent discharge for 3 weeks without any urological or upper respiratory tract symptoms. Conjunctival Neisseria gonorrhoeae and Chlamydia trachomatis infection was identified using cultures and polymerase chain reaction; pharyngeal swab culture and polymerase chain reaction showed positive results for both pathogens. The patient was probably under influence of party drugs at the time of sexual abuse when he became infected. After parenteral and oral cephalosporin and azithromycin therapy the patient had complete recovery within three weeks.. A keratoconjunctivitis gonorrhoica ritka, a Neisseria gonorrhoeae által okozott gennyes váladékozással kísért kötőhártya-gyulladás, amelyet felnőtteknél a szembe kerülő fertőző váladék okozhat. A Chlamydia trachomatis D-K szerotípusa által okozott conjunctivitis felnőttkori formáját nemi váladékok szembe kerülésével létrejött, kétoldali mucopurulens váladékozással kísért gyulladás jellemzi. A szerzők egy 33 éves, syphilis latens tarda miatt gondozott férfi beteg esetét ismertetik, akinek a hetek óta fennálló purulens conjunctivitise hátterében a mikrobiológiai vizsgálatok során Chlamydia trachomatis-fertőzéssel kombinált Neisseria gonorrhoeae-infekció igazolódott. A tenyésztéses és PCR-vizsgálatok során a pharynxból is kimutatható volt mindkét kórokozó. A betegnek sem urológiai, sem felső légúti tünetei nem voltak. A fertőződés kábítószer hatása alatt történt szexuális abúzust követően alakult ki. A parenteralis, majd per os cephalosporin- és azithromycinterápia hatására három hét alatt teljes remisszió következett be. Orv. Hetil., 2013, 154, 834–837.

Topics: Acute Disease; Administration, Oral; Adult; Anti-Bacterial Agents; Azithromycin; Cephalosporins; Chlamydia trachomatis; Coinfection; Conjunctivitis, Bacterial; Conjunctivitis, Inclusion; Homosexuality, Male; Humans; Injections, Intravenous; Male; Neisseria gonorrhoeae; Polymerase Chain Reaction; Sex Offenses; Sexual Behavior; Staphylococcus aureus

Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in 'real-world' settings.. To describe a strategy that identifies potentially drug-induced acute myocardial infarction (AMI) from a large international healthcare data network.. Post-marketing safety surveillance was conducted in seven population-based healthcare databases in three countries (Denmark, Italy, and the Netherlands) using anonymised demographic, clinical, and prescription/dispensing data representing 21,171,291 individuals with 154,474,063 person-years of follow-up in the period 1996-2010. Primary care physicians' medical records and administrative claims containing reimbursements for filled prescriptions, laboratory tests, and hospitalisations were evaluated using a three-tier triage system of detection, filtering, and substantiation that generated a list of drugs potentially associated with AMI. Outcome of interest was statistically significant increased risk of AMI during drug exposure that has not been previously described in current literature and is biologically plausible.. Overall, 163 drugs were identified to be associated with increased risk of AMI during preliminary screening. Of these, 124 drugs were eliminated after adjustment for possible bias and confounding. With subsequent application of criteria for novelty and biological plausibility, association with AMI remained for nine drugs ('prime suspects'): azithromycin; erythromycin; roxithromycin; metoclopramide; cisapride; domperidone; betamethasone; fluconazole; and megestrol acetate.. Although global health status, co-morbidities, and time-invariant factors were adjusted for, residual confounding cannot be ruled out.. A strategy to identify potentially drug-induced AMI from electronic healthcare data has been proposed that takes into account not only statistical association, but also public health relevance, novelty, and biological plausibility. Although this strategy needs to be further evaluated using other healthcare data sources, the list of 'prime suspects' makes a good starting point for further clinical, laboratory, and epidemiologic investigation.

Topics: Acute Disease; Adverse Drug Reaction Reporting Systems; Azithromycin; Betamethasone; Cisapride; Domperidone; Electronic Health Records; Fluconazole; Humans; Megestrol Acetate; Metoclopramide; Myocardial Infarction

Calcium-channel blockers are metabolized by the cytochrome P450 3A4 (CYP3A4; EC 1.14.13.97) enzyme. Blood concentrations of these drugs may rise to harmful levels when CYP3A4 activity is inhibited. Clarithromycin is an inhibitor of CYP3A4 and azithromycin is not, which makes comparisons between these 2 macrolide antibiotics useful in assessing clinically important drug interactions.. To characterize the risk of acute adverse events following coprescription of clarithromycin compared with azithromycin in older adults taking a calcium-channel blocker.. Population-based retrospective cohort study in Ontario, Canada, from 2003 through 2012 of older adults (mean age, 76 years) who were newly coprescribed clarithromycin (n = 96,226) or azithromycin (n = 94,083) while taking a calcium-channel blocker (amlodipine, felodipine, nifedipine, diltiazem, or verapamil).. Hospitalization with acute kidney injury (primary outcome) and hospitalization with hypotension and all-cause mortality (secondary outcomes examined separately). Outcomes were assessed within 30 days of a new coprescription.. There were no differences in measured baseline characteristics between the clarithromycin and azithromycin groups. Amlodipine was the most commonly prescribed calcium-channel blocker (more than 50% of patients). Coprescribing clarithromycin vs azithromycin with a calcium-channel blocker was associated with a higher risk of hospitalization with acute kidney injury (420 patients of 96,226 taking clarithromycin [0.44%] vs 208 patients of 94,083 taking azithromycin [0.22%]; absolute risk increase, 0.22% [95% CI, 0.16%-0.27%]; odds ratio [OR], 1.98 [95% CI, 1.68-2.34]). In a subgroup analysis, the risk was highest with dihydropyridines, particularly nifedipine (OR, 5.33 [95% CI, 3.39-8.38]; absolute risk increase, 0.63% [95% CI, 0.49%-0.78%]). Coprescription with clarithromycin was also associated with a higher risk of hospitalization with hypotension (111 patients of 96,226 taking clarithromycin [0.12%] vs 68 patients of 94,083 taking azithromycin [0.07%]; absolute risk increase, 0.04% [95% CI, 0.02%-0.07%]; OR, 1.60 [95% CI, 1.18-2.16]) and all-cause mortality (984 patients of 96,226 taking clarithromycin [1.02%] vs 555 patients of 94,083 taking azithromycin [0.59%]; absolute risk increase, 0.43% [95% CI, 0.35%-0.51%]; OR, 1.74 [95% CI, 1.57-1.93]).. Among older adults taking a calcium-channel blocker, concurrent use of clarithromycin compared with azithromycin was associated with a small but statistically significant greater 30-day risk of hospitalization with acute kidney injury. These findings support current safety warnings regarding concurrent use of CYP3A4 inhibitors and calcium-channel blockers.

Topics: Acute Disease; Acute Kidney Injury; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Calcium Channel Blockers; Clarithromycin; Cohort Studies; Cytochrome P-450 CYP3A; Drug Interactions; Female; Hospitalization; Humans; Male; Practice Patterns, Physicians'; Retrospective Studies; Risk

Macrolide antibiotics are known to have various anti-inflammatory effects in addition to their antimicrobial activity, but the mechanisms are still unclear. The effect of azithromycin on inflammatory molecules in the lipopolysaccharide-induced rat conjunctivitis model was investigated.. Twenty-four Wistar rats were divided into two groups receiving topical ocular azithromycin (15 mg/g) or vehicle. In total, six doses (25 µl) were administered as one dose twice a day for three days before subconjunctival lipopolysaccharide injection (3 mg/ml). Before the rats were euthanized, mucus secretion, conjunctival and palpebral edema and redness were evaluated. Real-time polymerase chain reaction was used to determine gene expression for interleukin-6, cyclooxygenase-2, tumor necrosis factor-α, matrix metalloproteinase (MMP)-2, and MMP-9. Interleukin-6 was determined with enzyme-linked immunosorbent assay, nuclear factor-kappa B with western blot, and MMP-2 activity with gelatin zymogram. Four eyes per group were processed for histology and subsequent periodic acid-Schiff staining and CD68 for immunofluorescence. The Student t test or the Wilcoxon test for independent samples was applied (SPSS v.15.0).. Azithromycin-treated animals showed a significant reduction in all clinical signs (p<0.05) compared to controls. Interleukin-6 (p<0.05), nuclear factor-kappa B protein expression (p<0.01), and MMP-2 activity (p<0.05) in conjunctival homogenates were significantly reduced compared with the control animals. MMP-2 gene expression showed a tendency to decrease in the azithromycin group (p=0.063). Mucus secretion by goblet cells and the macrophage count in conjunctival tissue were also decreased in the azithromycin group (p<0.05).. These results suggest that azithromycin administration ameliorates induced inflammation effects in a rat model of acute conjunctivitis.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Azithromycin; Conjunctivitis; Cyclooxygenase 2; Disease Models, Animal; Gene Expression; Interleukin-6; Matrix Metalloproteinase 2; Matrix Metalloproteinase 9; NF-kappa B; Rats; Rats, Wistar; Tumor Necrosis Factor-alpha

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Azithromycin; Cheek; Conjunctivitis; Dermatitis, Allergic Contact; Eczema; Eyelid Diseases; Facial Dermatoses; Female; Humans; Ophthalmic Solutions

To evaluate the efficacy and safety of single-dose 2.0 g azithromycin (ZSR) in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AE-COPD), we retrospectively reviewed all patients with AE-COPD who were treated with ZSR. In comparison with patients who received intravenous therapy for AE-COPD, the clinical cure rate, length of stay in hospital, and medical costs were evaluated. A total of 29 patients thus were eligible for this study. Clinical cure rates of ZSR and intravenous therapy for the treatment of AE-COPD were 83.3% (n = 12) and 88.2% (n = 17), respectively, between the groups (P = 1.000). No severe adverse events were found in either group. The ZSR and intravenous groups averaged 9.9 and 12.5 days of admission, respectively. Length of admission for clinical success cases was much shorter for patients who received ZSR than patients who received intravenous therapy (6.2 vs. 11.9 days, P = 0.038). Medical costs were less for the group receiving ZSR than for the intravenous therapy group. We suggest ZSR can achieve near-perfect compliance and could be one of the tools in the treatment of AE-COPD.

Topics: Acute Disease; Aged; Analysis of Variance; Anti-Bacterial Agents; Azithromycin; Female; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Retrospective Studies; Treatment Outcome

To describe the clinical, optical coherence tomographic, and angiographic findings in patients with acute toxoplasmic retinochoroiditis (RC) associated with serous retinal detachment (SRD).. The study included 60 eyes with acute toxoplasmic RC.. Of 60 eyes, 14 (23.3%) were found to have SRD. The SRD was visible on fundus examination in 6 cases and detectable only by optical coherence tomography (OCT) in the 8 remaining cases. It involved the fovea in 9 eyes. There was evidence of associated choroidal ischemia on fluorescein angiography and indocyanine green angiography in 5 eyes. Findings seen at the acute stage gradually resolved over a period of 2-6 weeks in all patients.. SRD, accurately detected by OCT, is a common complication of acute toxoplasmic RC that should be considered as a potential cause of visual loss. Choroidal ischemia might contribute to the development of such complication.

Topics: Acute Disease; Adult; Antiprotozoal Agents; Azithromycin; Chorioretinitis; Female; Fluorescein Angiography; Humans; Indocyanine Green; Male; Prednisone; Pyrimethamine; Retinal Detachment; Tomography, Optical Coherence; Toxoplasmosis, Ocular; Treatment Outcome; Young Adult

The aim of this study is to examine the internalization of nontypeable Haemophilus influenzae (NTHi) into human epithelial cells.. Bactericidal assay was applied to examine the effects of antibiotics against cell-adherent NTHi using HEp-2 cells. A trans-well chamber assay was applied to examine the internalization and penetration of NTHi using Detroit562 cells.. The adherence of NTHi to HEp-2 cells was noted after 2h of incubation. Azithromycin had a strong bactericidal effect against both cell-associated and non-adherent NTHi, while ceftriaxone did not show bactericidal effects on NTHi adhered to the HEp-2 cells. Three (60.0%) out of five NTHi isolates from the nasopharynx of children with intractable acute otitis media (AOM) internalized into and subsequently penetrated through the epithelial cells at various degrees. Azithromycin had a strong bactericidal effect against the cell-internalized NTHi, while ceftriaxone was bactericidal only against extracellular NTHi.. The potential of NTHi as the intracellular pathogen may contribute to the persistent existence of this pathogen that result in the prolonged and intractable clinical course of AOM. Azithromycin may be a therapeutically significant antibiotic for patients with prolonged respiratory tract infections due to NTHi.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Bacterial Adhesion; Bacterial Physiological Phenomena; Ceftriaxone; Cell Line; Child; Dose-Response Relationship, Drug; Epithelial Cells; Gentamicins; Haemophilus Infections; Haemophilus influenzae; Humans; In Vitro Techniques; Microbial Sensitivity Tests; Microbial Viability; Otitis Media with Effusion

Epidemiological and pathological evidence links highly prevalent pathogens to chronic inflammatory diseases, such as type 2 diabetes. Animal models contribute critically to the mechanistic understanding of infectious enhancement of inflammatory diseases, which share insulin resistance as the central pathophysiological defect.. With use of a mouse model, we examined insulin resistance progression and the influence of infection (Chlamydia pneumoniae-infected vs. uninfected control mice), genetic background (C57BL/6 vs. A/J mice), dietary fat concentration (27% vs. 5%), and time (2, 5, 9, or 15 weeks after inoculation).. In obese C57BL/6 mice, C. pneumoniae infection induced significantly increased insulin resistance that persisted long after bacterial clearance. Circulating tumor necrosis factor (TNF)-alpha produced in response to acute C. pneumoniae lung colonization exacerbated insulin resistance but not TNF-alpha released in situ during secondary chlamydial infection. Azithromycin or anti-TNF-alpha antibody prevented infection-exacerbated insulin resistance but significantly enhanced chlamydial dissemination to the heart. Azithromycin-treated mice did not eliminate C. pneumoniae from lungs by 3 weeks after inoculation but had significantly lower loads (42 genomes per 100 mg) than did control mice (219 genomes per 100 mg) or anti-TNF-alpha antibody-treated mice (3090 genomes per 100 mg).. Murine C. pneumoniae infection enhanced insulin resistance development in a genetically and nutritionally restricted manner via circulating mediators. The relevance for the current human diabetes epidemic remains to be determined, but this finding is potentially important because of the high prevalence of human C. pneumoniae infection worldwide.

Topics: Acute Disease; Animals; Azithromycin; Chlamydophila Infections; Chlamydophila pneumoniae; Diabetes Mellitus, Type 2; Fatty Acids, Nonesterified; Insulin Resistance; Male; Mice; Mice, Inbred A; Mice, Inbred C57BL; Mice, Obese; Obesity; Pneumonia, Bacterial; Recurrence; Tumor Necrosis Factor-alpha

Azithromycin (AZM) is widely used for respiratory tract infections and otitis media because of its activity against Haemophilus influenzae and atypical pathogens, and its ease of administration. Although leukopenia is the one of the most frequent AZM-related laboratory abnormalities in children, agranulocytosis has not been reported in adults. Here, we present the case of an 81-year-old man with agranulocytosis following AZM-treatment for acute otitis media. He developed febrile neutropenia and granulocyte colony-stimulating factor and cefepim were administered. All his symptoms and absolute neutrophil counts were recovered within 7 days after admission. Physicians must be vigilant in identifying drug-induced neutropenia in AZM-treated patients because early detection can decrease the severity and prevent mortality.

Topics: Acute Disease; Aged, 80 and over; Agranulocytosis; Anti-Bacterial Agents; Azithromycin; Humans; Male; Otitis Media

Q fever is a zoonosis caused by Coxiella burnetii. Although data on Q fever during pregnancy are limited, they indicate that infection with C. burnetii is associated with high morbidity and mortality. The infection is usually asymptomatic in pregnant women but may result in obstetric complications such as spontaneous abortion, intrauterine growth retardation, intrauterine fetal death and premature delivery; in addition, pregnant women are at higher risk of developing chronic Q fever. Treatment of Q fever during pregnancy is challenging not only because C. burnetii is an intracellular bacterium but also because of safety restrictions and limited information on the efficacy of treatment. We report a case of acute Q fever in pregnancy with a successful outcome for mother and child, describe our therapeutic approach to the management of this case, and suggest that treatment with azithromycin may have prevented possible obstetric complications and evolution toward a chronic serologic profile in our patient.

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Azithromycin; Coxiella burnetii; Female; Follow-Up Studies; Humans; Infant, Newborn; Pregnancy; Pregnancy Complications, Infectious; Q Fever; Time Factors; Treatment Outcome

Thermal injury to the epiglottis as a result of ingestion of hot food should be considered in the differential diagnosis of earache, severe throat pain and odynophagia. We report a case of a 48-year-old physician, who developed acute, severe throat pain, odynophagia and earache after inadvertent ingestion of hot food. This case is unique, as the physician performed the endoscopy on himself and diagnosed thermal epiglottitis. The epiglottitis responded to a short course of steroids and antibiotics. The physician has remained symptom free since treatment.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Burns; Endoscopy, Digestive System; Epiglottis; Epiglottitis; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Ulcer

Topics: Acute Disease; Adolescent; Antitussive Agents; Azithromycin; Diagnosis, Differential; Humans; Male; Whooping Cough

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Humans; India; Penicillin G Benzathine; Pharyngitis; Practice Guidelines as Topic; Rheumatic Fever; Rheumatic Heart Disease; Streptococcal Infections

Acute pancreatitis is an important cause of morbidity and mortality, mainly due to sepsis. The aim of this study was to determine the incidence of infectious complications and their impact on mortality in patients hospitalized for acute pancreatitis.. Patients admitted for acute pancreatitis were retrospectively included within a period between 1995 and 2000. Incidence of abdominal and extra-abdominal sepsis and specific care were specifically analyzed. Risk factors for death were evaluated by uni- and multivariated analysis.. Two hundreds and twelve consecutive patients (128 males, median age 54 years) were included. Mortality was 10.8%. At least one infectious episode was collected in 25% of the patients with an abdominal sepsis (26.8%), bacteriemia (24.4%), respiratory (24.4%) and urinary tracts (19.5%) infections. Infection was polymicrobial in 37.5%. An antibiotic prophylaxis was administered in 10.8%, more often in patients with severe pancreatitis. It did not alter mortality or incidence of infections but significantly delayed occurrence of sepsis. Mortality of patients treated with more than one line of antibiotics was higher. However in this study infectious complications were not an independent factor for mortality.. Infections are frequent and polymicrobial but are not an independent prognostic factor during acute pancreatitis.

Topics: Acute Disease; Adult; Age Factors; Aged; Aged, 80 and over; Amoxicillin; Anti-Bacterial Agents; Antibiotic Prophylaxis; APACHE; Azithromycin; Bacterial Infections; Ceftriaxone; Data Interpretation, Statistical; Drug Therapy, Combination; Female; Humans; Incidence; Male; Middle Aged; Pancreatitis; Prognosis; Retrospective Studies; Risk Factors; Sepsis; Time Factors

Babesia gibsoni is a protozoan parasite of dogs worldwide yet both an effective treatment and a reliable method for detecting subclinical cases of this emerging infection remain elusive. Experimental B. gibsoni infections were established in vivo to investigate the efficacy of combined atovaquone and azithromycin drug therapy and to determine the detection limits of a nested-PCR, IFAT and microscopy during various stages of infection. While atovaquone and azithromycin produced a reduction in parasitaemia, it did not eliminate the parasite and drug resistance appeared to develop in one dog. Polymerase chain reaction was found to be most useful in detecting infection in the pre-acute and acute stages, while IFAT was most reliable during chronic infections. Microscopy is suggested to be only effective for detecting acute stage infections. This study also describes the detection of B. gibsoni in tissue samples during chronic infections for the first time, suggesting possible sequestration of this parasite.

Topics: Acute Disease; Animals; Anti-Infective Agents; Antibodies, Protozoan; Atovaquone; Azithromycin; Babesia; Babesiosis; Chronic Disease; DNA, Protozoan; Dog Diseases; Dogs; Drug Resistance; Female; Fluorescent Antibody Technique; Parasitemia; Polymerase Chain Reaction

To describe eight patients with active toxoplasmic retinochoroiditis (RC) who had features suggestive of acute choroidal ischemia.. A retrospective review of the clinical records of 23 consecutive patients with acute toxoplasmic RC was performed. All patients underwent detailed ophthalmic examination at presentation and throughout follow-up, including dilated biomicroscopic fundus examination, fundus photography, fluorescein angiography, and indocyanine green (ICG) angiography.. Of 23 patients, 8 (34.8%) had a large area of retinal whitening surrounding a small focus of RC. Fluorescein as well as ICG angiography showed a well demarcated geographic area of early choroidal hypofluorescence that extended beyond the clinical borders of the white retinal lesion, particularly by ICG angiography. Associated findings for these 8 patients included old retinochoroidal scars (7 [87.5%]), serous retinal detachment (3 [37.5%]), retinal hemorrhages (1 [12.5%]), and multiple satellite dark dots by ICG angiography (6 [75%]). Seven of eight patients were treated using a combination of antitoxoplasmic drugs and corticosteroids. All findings seen at the acute stage resolved in 2 weeks to 6 weeks. A small atrophic retinochoroidal scar replaced the active toxoplasmic lesion and was surrounded with mild or moderate retinal pigment epithelium changes that were associated with decreased final visual acuity in 2 patients (25%).. Patients with toxoplasmic RC may develop features suggestive of choroidal ischemia that can result in a transient or permanent decrease in vision. Choroidal ischemia can only be suspected clinically, and fluorescein angiography and ICG angiography are required to establish the definitive diagnosis.

Topics: Acute Disease; Adult; Azithromycin; Chorioretinitis; Choroid; Coloring Agents; Drug Therapy, Combination; Female; Fluorescein Angiography; Humans; Indocyanine Green; Ischemia; Leucovorin; Male; Prednisone; Pyrimethamine; Retrospective Studies; Toxoplasmosis, Ocular

A 16-year-old heterosexual man presented to our hospital with a purulent urethral discharge and pain at voiding. These symptoms began seven days after oral-genital contact (fellatio) with his partner. A Gram-stained smear from the urethral discharge showed Gram-negative diplococci, and the antigen of Chlamydia trachomatis from urine was positive. We initially made a diagnosis of urethritis caused by Neisseria gonorrhoeae and C. trachomatis. However, N. meningitidis was isolated by culture. Clinicians should pay attention to the possibility of N. meningitidis infection in all cases resembling gonococcal urethritis.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Chlamydia Infections; Chlamydia trachomatis; Contact Tracing; Humans; Male; Meningococcal Infections; Neisseria meningitidis; Spectinomycin; Treatment Outcome; Urethritis

A previous study found that a single 2-g dose of azithromycin extended release (AZ-ER) was as efficacious as 10 days of levofloxacin (LFX) 500 mg QD in adults with acute bacterial rhinosinusitis (ABRS). The speed with which patients experience resolution of ABRS symptoms has not been reported.. The purpose of this study was to evaluate the resolution of ABRS symptoms after a single 2-g dose of AZ-ER compared with 10 days of LFX.. This was a retrospective analysis of data from a published international, randomized, double-blind, double-dummy clinical trial conducted between January 21, 2003, and February 20, 2004, that included 534 adult (age >or=18 years) outpatients with ABRS. All patients entering the study were required to have purulent nasal discharge, purulent drainage in the posterior pharynx, or purulent discharge from the maxillary sinus orifice and at least 1 of 3 other protocol-defined cardinal symptoms of ABRS (sinus pain, pressure, or tenderness) for >or=7 days. In addition, they were required to have at least 2 of the following 6 noncardinal symptoms at baseline: cough, fever, headache, nasal congestion, postnasal discharge, and leukocytosis. All patients who received medication were assessed for the occurrence of adverse events at study visits during and after therapy. At the ontreatment visit (between days 3 and 5), baseline symptoms were reassessed as resolved, improved, same, new, or worse. Resolution of symptoms was calculated as the proportion of patients with 3 or 4 cardinal symptoms either resolved (if present at baseline) or not new (if absent at baseline). Concomitant medications other than antibiotics were allowed as needed for symptomatic treatment.. Demographic characteristics were similar at baseline between the AZ-ER and LFX treatment arms (mean age, 38.4 and 39.5 years, respectively), although more women were randomized to receive LFX (62.9%) than AZ-ER (53.3%) (P = 0.025). More than 90% of patients in both arms had >or=3 ABRS symptoms at baseline. At the on-treatment visit, resolution of >or=3 ABRS symptoms was achieved in 88 of 270 AZ-ER patients (32.6%) and 61 of 261 LFX patients (23.4%) (P = 0.018). Resolution of individual symptoms in the AZ-ER and LFX groups at 3 to 5 days was as follows: sinus pain (92/253[36.4%] and 77/251 [30.7%]; P = NS), sinus pressure (97/243 [39.9%] and 68/244 [27.9%]; P = 0.005), sinus tenderness (83/218 [38.1%] and 73/214 [34.1%]; P = NS), and nasal discharge (57/270 [21.0%] and 49/264 [18.6%]; P = NS). Treatment-related adverse events were reported by 63 of 270 AZ-ER patients (23.3%) and 41 of 268 LFX patients (15.3%). Gastrointestinal disturbances were the most common adverse events, including nausea (4.4% and 3.4%) and abdominal pain (2.6% and 0.4%).

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Azithromycin; Delayed-Action Preparations; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Randomized Controlled Trials as Topic; Retrospective Studies; Rhinitis; Sinusitis; Treatment Outcome

Acute bacterial rhinosinusitis, which is a major health problem, is treated with antibiotics. We developed a mouse model of acute bacterial rhinosinusitis to gain a better understanding of the pathophysiology of the disease. Our goal was to investigate the response to acute rhinosinusitis when treated with either a bactericidal or a bacteriostatic antibiotic.. C57BL/6 mice were infected intranasally with Streptococcus pneumoniae. One day after inoculation, the mice were treated with either moxifloxacin (bactericidal) or azithromycin (bacteriostatic). Different groups were euthanized during the first five days post-inoculation. Bacterial counts from nasal lavage culture and the cell markers GR1, CD11b, CD3, CD4, and CD8 in sinus tissue were evaluated by flow cytometry.. Azithromycin led to rapid clearance of the bacteria and of the inflammation in contrast to placebo. Surprisingly, moxifloxacin showed a limited effect. Investigations of this limited effect of moxifloxacin suggested a high metabolic clearance, a low concentration at the site of infection, and low persistent post-antibiotic effects of moxifloxacin in mice.. Our animal model of acute sinusitis has great utility for studying the disease, but the difference between mice and man must always be considered in making extrapolations from animal experiments to the human experience.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Aza Compounds; Azithromycin; CD11b Antigen; CD4 Antigens; CD8 Antigens; Disease Models, Animal; Female; Fluoroquinolones; Male; Mice; Mice, Inbred C57BL; Moxifloxacin; Pneumococcal Infections; Quinolines; Rhinitis; Sinusitis; Streptococcus pneumoniae

This case is reported with the intention of highlighting the presentation of primary amebic meningoencephalitis as acute meningitis, a rare differential diagnosis with presence of free living amoebas in the CSF.

Topics: Acute Disease; Adult; Amebiasis; Animals; Anti-Bacterial Agents; Azithromycin; Diagnosis, Differential; Humans; Male; Meningoencephalitis

To report a case of severe bilateral anterior uveitis associated with Mycoplasma pneumoniae without pulmonary manifestations.. A healthy 5-year-old girl developed severe bilateral anterior uveitis accompanied by fever, arthralgia, gastrointestinal complaints, and lethargy. Results of laboratory investigations were normal except for high levels of Mycoplasma pneumoniae antibodies. The uveitis subsided with topical application of steroids, cycloplegia, and with oral azithromycin. Although Mycoplasma pneumoniae is a rare cause of uveitis, it should be considered in patients presenting with uveitis, even with no accompanying pulmonary or other typical systemic mycoplasmal manifestations.

Topics: Acute Disease; Anti-Bacterial Agents; Antibodies, Bacterial; Azithromycin; Child, Preschool; Dexamethasone; Drug Therapy, Combination; Eye Infections, Bacterial; Female; Functional Laterality; Glucocorticoids; Humans; Mycoplasma pneumoniae; Pneumonia, Mycoplasma; Uveitis, Anterior

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

Population-based studies may give results different from randomized clinical trials assessing the efficacy of antibiotics.. To determine the effectiveness of amoxicillin, azithromycin, cefprozil and clarithromycin in the treatment of acute otitis media (AOM) in children.. Using Quebec Health Insurance databases (RAMQ), we selected a cohort of children aged < or = 6 years, with a first episode of AOM between 1999 and 2002. The index AOM was defined as a medical service claim with a diagnosis of AOM and an antibiotic dispensation in the following 72 hours. Failures were defined as a new antibiotic dispensation, a hospitalization or outpatient visit for complications related to AOM in the 30 days after the index AOM. Data were analyzed using logistic regression.. Overall, 12,693 failures occurred among 60,513 first episodes of AOM. Azithromycin was the only antibiotic that was associated with a decreased risk of failure overall, when compared to amoxicillin (OR 0.88, 95% CI: 0.82, 0.94). However in the first 3 days of treatment (n = 680), azithromycin was more associated with treatment failure (OR 1.6, 95% CI: 1.3, 2.0). Compared to amoxicillin, post-therapy failures (n = 9387) were more likely to occur with cefprozil (OR 1.2, 95%CI: 1.2, 1.3) but were less with azithromycin (OR 0.8 95% CI: 0.8, 0.9).. Azithromycin had the lowest risk of failure 30 days after the onset of treatment but an increased risk of failure during the first few days of treatment. Amoxicillin remains an effective first-line drug for treating first AOM episodes.

Topics: Acute Disease; Administration, Oral; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cefprozil; Cephalosporins; Child; Child, Preschool; Clarithromycin; Cohort Studies; Female; Follow-Up Studies; Humans; Male; Otitis Media; Quebec; Risk Factors; Time Factors; Treatment Outcome

Sixty-five consecutive eligible adult patients, who were treated as outpatients for stable severe-to-very severe COPD, were enrolled in the study. All of them received 23-valent pneumococcal capsular polysaccharide vaccine intramuscularly. Patients were seen monthly, as well as whenever they had symptoms suggestive of an exacerbation, at our outpatient clinic. Eighteen out of 65 patients suffered from acute exacerbation (AECOPD). Three of these patients presented two episodes of AECOPD. Patients with an acute exacerbation of COPD received azithromycin 500 mg/day once daily for 3 days and a short course of oral prednisolone 25 mg/die. In 16 cases, a single species was isolated, while in the remaining 5 cases at least two species were recovered. Clinical cure or improvement at the end of therapy (3-5 days post-therapy) was reported in 17 episodes of AECOPD with no relapse at the late post-therapy (10-14 days after the completion of treatment). Bacteriologic eradication or presumptive eradication rates at the end of therapy were 86% (24 out of 28 isolates). Azithromycin eradicated all isolates of Haemophilus influenzae, Moraxella catarrhalis, H. parainfluenzae, Klebsiella pneumoniae, and Klebsiella spp. isolated at baseline. Eradication of Sta aureus occurred in 1 of 3 isolates whereas azithromycin was unable to eradicate Pseudomonas aeruginosa isolates. Our data seem to indicate that pneumococcal vaccination reduces the possibility that an AECOPD is caused by Streptococcus pneumoniae. This finding allows the use of antibiotics such as azithromycin, which, otherwise, should be avoided because of resistances.

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Azithromycin; Female; Haemophilus; Humans; Klebsiella; Male; Middle Aged; Moraxella catarrhalis; Pneumococcal Vaccines; Pulmonary Disease, Chronic Obstructive; Recurrence; Streptococcus pneumoniae; Treatment Outcome

Topics: Acute Disease; Angina, Unstable; Azithromycin; Chlamydophila Infections; Humans; Inflammation; Intercellular Adhesion Molecule-1; Myocardial Infarction; Survivors; Syndrome

Topics: Acute Disease; Azithromycin; Bacterial Infections; Chemistry, Pharmaceutical; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Maxillary Sinusitis; Microspheres; Ofloxacin; Randomized Controlled Trials as Topic; Rhinitis; Risk Assessment; Severity of Illness Index; Treatment Outcome

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Azithromycin; Cefprozil; Ceftriaxone; Cephalosporins; Drug Resistance, Multiple, Bacterial; Humans; Microbial Sensitivity Tests; Otitis Media; Risk Assessment; Sensitivity and Specificity; Streptococcus pneumoniae

Topics: Acute Disease; Amoxicillin; Azithromycin; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media; Prospective Studies; Risk Assessment; Severity of Illness Index; Treatment Outcome

Traditional approaches to antimicrobial management of acute bacterial rhinosinusitis (ABRS) focus on courses of therapy of at least 10 days duration. The rationale for this length of therapy originated from studies in tonsillopharyngitis. Short-course antibiotic therapy for ABRS with 3-5 days of azithromycin has proved equally effective. Potential added benefits of short-course therapy include improved compliance, fewer adverse events as well as reduced risk of treatment failure, bacterial resistance and cost. Single-dose therapy is now possible with a novel microsphere formulation of azithromycin, which permits administration of a higher 2.0 g oral dose. This has proved as effective and well tolerated as 10 days levofioxacin 500 mg/day in patients with uncomplicated ABRS. High single-dose therapy has the potential to maximize adherence to prescribed therapy and thus to help in the battle to control rising antibiotic resistance among respiratory pathogens.

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Microspheres; Middle Aged; Ofloxacin; Rhinitis; Sinusitis; Time Factors; Treatment Outcome

The authors report a case of Q fever infection that caused acute exacerbation of chronic respiratory failure, which had developed as a sequela of pulmonary tuberculosis. This case was found on wide-ranging serological screening for respiratory infection performed in order to investigate the prevalence of Q fever in Japan. A 73-year-old man who had been treated for hypertension and sequelae of pulmonary tuberculosis was admitted to our hospital because of fever, productive cough, and dyspnea on effort. Hypoxia and right heart failure were detected on arterial blood analysis and ultrasonography. The acute exacerbation was triggered by respiratory infection and although the infection improved on azithromycin treatment after admission, respiratory failure continued for the period of admission. Home oxygen therapy was required for the management of chronic respiratory failure on discharge. Paired serum samples were tested for antibodies against Coxiella burnetii by indirect immunofluorescence, showing an elevated antibody titer in the convalescent phase. We believe that Q fever infection caused acute exacerbation of chronic respiratory failure, and that C. burnetii is an agent that might influence the clinical course of chronic respiratory failure.

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Antibodies, Bacterial; Azithromycin; Chronic Disease; Coxiella burnetii; Fluorescent Antibody Technique, Indirect; Humans; Male; Oxygen Inhalation Therapy; Q Fever; Respiratory Insufficiency; Serologic Tests

Acute otitis media (AOM) is one of the most common diseases of childhood. Knowledge, of which bacteria are the most common pathogens in AOM and their susceptibilities towards antibiotics, is essential for the reasonable empiric treatment. With rapidly increasing frequencies of antibiotic resistance surveillance of the common etiologic pathogens has become pertinent. The purpose of this paper is to present the bacteriological findings and antibiotic susceptibilities, in cultures from nasopharyngeal swabs, in Danish children with AOM.. Children aged up to 10 years who had AOM diagnosed in general practice in Denmark were swabbed in nasopharynx, cultures were incubated and susceptibility testing was performed as tablet diffusion and minimal inhibitory concentrations (MICs) were determined by E-test.. We included 331 patients, in 257 bacteria were found, which could be classified as commonly ear pathogenic. The most frequent bacteria found was Streptococcus pneumoniae followed by Haemophilus influenzae and Moraxella catarrhalis. Ninety-six percent of the tested S. pneumoniae were susceptible towards penicillin and 99% towards erythromycin. Eighty-nine percent of the H. influenzae were susceptible to ampicillin and all tested M. catarrhalis were susceptible towards erythromycin. In more than 30% of H. influenzae MIC of phenoxymethylpenicillin were above the level that could be achieved in middle ear fluid.. Antimicrobial resistance is still infrequent in pathogens that might cause AOM in children in Denmark; this is probably due to minimal use of antibiotics as well as the use of phenoxymethylpenicillin as primary drug for treatment of AOM. Phenoxymethylpenicillin and azithromycin are not efficient for treating the majority of infections due to H. influenzae.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Child; Child, Preschool; Denmark; Drug Utilization; Female; Humans; Infant; Male; Nasopharynx; Otitis Media, Suppurative; Penicillin V

A 14-year-old girl is reported with recurrent, azithromycin-induced, acute interstitial nephritis. The second episode was more severe than the first; and although both were treated with intensive corticosteroid therapy, renal function remained impaired. Although most cases of antibiotic induced acute interstitial nephritis are benign and self-limited, some patients are at risk for permanent renal injury.

Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Azithromycin; Female; Glucocorticoids; Humans; Methylprednisolone; Nephritis, Interstitial; Prednisone; Recurrence

To ascertain the prevalence of acute trachoma as a supposed endemic disease among infants in the Saharan refugee camps of Tindouf (Algeria) and to evaluate the efficacy of treatment with a single dose of azithromycin.. 527 children aged between 3 and 17 were evaluated in the camp schools in October 2001. All the children were clinically and microbiologically examined, including slit lamp checks of anterior segment and two conjunctival swabs, one for the detection of membrane lipopolysaccharide by quick immunoassay test Clearview Chlamydia MF and the other for the detection of specific DNA by chlamydia plasmid specific polymerase chain reaction (PCR) assay. After examination, a single dose of azithromycin was administered to each child. One month later samples from positive children and 12 random negative children by the first PCR were taken to perform a new PCR assay.. Chlamydia trachomatis was suspected in 2.47% of the children, papillary hypertrophy being the most frequently seen clinical sign. Scarring changes secondary to trachoma were detected in 11.7% of the children. Only four cases (0.8%) were positive to the immunoassay test and 12 cases (2.27%) were positive by PCR. After treatment a second PCR was performed on positive children and they were negative of chlamydia DNA amplification. However, one child who was negative and received the treatment was positive in the second PCR assay.. Acute trachoma prevalence is much lower than expected among infants in this Saharan population. The possible reasons could be the recent improvements in hygiene and health care. Cicatricial trachoma is more frequent. The Clearview immunoassay test has very low sensitivity in the detection of this disease. A single dose of azithromycin is sufficient to treat chlamydial conjunctivitis. However, a programme of improvement in hygiene and health care is necessary to prevent re-infection.

Topics: Acute Disease; Adolescent; Algeria; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Chlamydia trachomatis; DNA, Bacterial; Epitopes; Female; Humans; Lipopolysaccharides; Male; Nucleic Acid Amplification Techniques; Polymerase Chain Reaction; Prevalence; Refugees; Trachoma

A total of 2865 strains of the causative organisms isolated from the patients with acute pharyngitis and tonsillitis at the primary medical institutions were used in this study. The MICs of levofloxacin (LVFX) and other oral antimicrobial drugs were determined and evaluated by the NCCLS guideline. LVFX, cefditoren (CDTR) and cefcapene (CFPN) were potently active against 773 isolates of Hemophilus influenzae, the MIC50S of LVFX being < or = 0.06 microgram/mL and also the same as the MIC90S of LVFX. LVFX was the most active against 496 isolates of Enterobacteriaceae. The MIC50S of LVFX were < or = 0.06 microgram/mL and were lower than those of CDTR, cefdinir (CFDN) and cefpodoxime (CPDX) (MIC50S: 0.5 microgram/mL). The MIC90S of these cephems were markedly higher than the respective MIC50S, whereas MIC50 of LVFX was 0.12 microgram/mL, only twice the MIC50. Against the majority of Streptococcus pyogenes (555 isolates) and Streptococcus spp. (495 isolates), CDTR, CFDN, CPDX and CFPN were highly active (MICs: < or = 0.06 microgram/mL), and clarithromycin (CAM) and azithromycin (AZM) were also active against these organisms (MICs: 0.12 to 0.25 microgram/mL). Against S. pneumoniae (92 isolates), CDTR and CFDN were active (MIC50S: 0.12 and 0.25 microgram/mL, respectively). However, the MIC90S of these drugs were 4-8 times the MIC50S. Against Moraxella (Branhamella) catarrhalis (454 isolates), LVFX was potently active, the MIC90 of LVFX being < or = 0.06 microgram/mL and MIC90S of the other cephems being 0.5 microgram/mL or more. When the susceptibility of these strains to LVFX was evaluated by the NCCLS guideline, about 3% of other Streptococcus spp. were resistant to the drug but no test strains resistant to LVFX were detected in H. influenzae, S. pyogenes or Enterobacteriaceae. On the other hand, the percentages of strains susceptible to the cephems tested were 60-90%, which were quite different according to kinds of drugs and species used. Furthermore, the strains of S. pneumoniae resistant to CFDN and CPDX, and those to CAM and AZM were 21-25% and 50% or more, respectively, whereas no LVFX-resistant strains were detected. The major pathogens isolated from patients with pharyngitis and tonsillitis in the primary institutions were highly susceptible to LVFX. These results suggest that LVFX is a useful drug which is potently active against the strains resistant to oral cephem and macrolide antibiotics.

Topics: Acute Disease; Ampicillin; Anti-Infective Agents; Azithromycin; Cefdinir; Cefpodoxime; Ceftizoxime; Cephalosporins; Clarithromycin; Enterobacteriaceae; Haemophilus influenzae; Humans; Levofloxacin; Ofloxacin; Penicillin G; Pharyngitis; Streptococcus pneumoniae; Streptococcus pyogenes; Tonsillitis

Treatment of acute otitis media (AOM) with azithromycin results in apparent clinical success, but tympanocentesis performed 4 to 6 days after initiation of therapy in children with nontypeable Haemophilus influenzae (NTHI) recovered from initial middle ear cultures demonstrates persistence of infection in more than 50% of episodes. We sought to determine the effect of azithromycin at different doses on the density of middle ear infection due to NTHI to provide additional understanding of this dichotomy between clinical and microbiologic outcome measures in AOM. In a chinchilla model of experimental otitis media (EOM), animals treated with placebo were compared to animals receiving a single daily dose 30 or 120 mg of azithromycin per kg of body weight per day for 5 days. Microbiologic outcome was assessed by obtaining quantitative cultures from the middle ear during a 5-day course and for 1 week following therapy. Azithromycin concentrations were measured to ascertain whether a concentration-dependent effect was present. Azithromycin at 30 and 120 mg/kg/day demonstrated a dose-dependent effect on the quantitative assessment of middle ear infection due to NTHI. A 30-mg/kg dose of azithromycin daily resulted in levels in serum and areas under the serum concentration-time curve at 24 h comparable to published data obtained with children given azithromycin at 5 to 10 mg/kg in multiday regimens. Increased doses of azithromycin (120 mg/kg) achieved 2.5- to 4-fold-higher levels in serum and 3- to 6-fold-higher total levels and levels in extracellular middle ear fluid as well as more rapid reduction in bacterial density and a greater proportion of middle ears with complete sterilization than either placebo or the 30-mg/kg/day regimen.

Topics: Acute Disease; Animals; Azithromycin; Chinchilla; Dose-Response Relationship, Drug; Haemophilus Infections; Haemophilus influenzae; Otitis Media

To evaluate the impact of treating children with acute trachoma and their contacts with oral azithromycin.. Open, uncontrolled, prospective evaluation of a community-based treatment strategy.. Central Australian semi-desert Aboriginal community (1995-1996).. 216 school- and pre-schoolchildren aged 6 months and up to 15 years.. All children with acute trachoma and their contacts (co-resident siblings aged between 6 months and 15 years) received single-dose oral azithromycin suspension (20 mg/kg, to a maximum of 1000 mg).. Prevalence of acute trachoma (World Health Organization trachoma diagnostic criteria).. Trachoma prevalence at baseline was 42% (71/169) and 55% (18/33) for schoolchildren and pre-schoolchildren, respectively: 103 schoolchildren and 21 pre-schoolchildren, comprising 77 with follicular trachoma and their 47 contacts, were treated with azithromycin over an 8-week period. Acute trachoma prevalence in schoolchildren fell to 22% at 6-8 months (P < 0.0001) and was 31% at 12 months (P < 0.05 compared with baseline). Pre-schoolchildren were followed up for 6 months after treatment, and their trachoma prevalence fell from 55% to 25% (P < 0.05). Further treatment was given to children with trachoma at 12 months, and the point prevalence of trachoma for schoolchildren at 24 months was 34%.. In contrast to mass-treatment strategies, significant reductions in trachoma prevalence at 6 months were achieved by screening 35% of community members (216) and treating 20% (124). The subsequent prevalence increases support the need for more comprehensive treatment programs, including health promotion and efforts to improve living conditions.

Topics: Acute Disease; Administration, Oral; Adolescent; Anti-Bacterial Agents; Azithromycin; Child; Child, Preschool; Humans; Infant; Native Hawaiian or Other Pacific Islander; Northern Territory; Population Surveillance; Prevalence; Prospective Studies; Rural Health; School Health Services; Trachoma; Treatment Outcome

Topics: Acute Disease; Anti-Bacterial Agents; Anti-Infective Agents; Azithromycin; Cefaclor; Cephalosporins; Clinical Trials as Topic; Humans; Otitis Media; Outcome Assessment, Health Care; Time Factors; Treatment Outcome

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Chemical and Drug Induced Liver Injury; Cholestasis, Intrahepatic; Female; Humans; Middle Aged

Topics: Acute Disease; Adenoids; Anti-Bacterial Agents; Azithromycin; Drug Administration Schedule; Humans; Penicillins; Pharyngitis; Tonsillitis; Treatment Outcome

Nasopharyngeal (NP) carriage of antibiotic-resistant Streptococcus pneumoniae was shown to be associated with recent antibiotic treatment. To date no studies have evaluated early dynamics of pneumococcal NP carriage during antibiotic treatment.. To observe changes in NP pneumococcal carriage within 3 to 4 days after initiation of antibiotic treatment in acute otitis media (AOM).. Patients ages 3 to 36 months with AOM treated with various antibiotics were prospectively followed. Nasopharyngeal culture for S. pneumoniae was obtained before (Day 1) and 72 to 96 h after initiation of treatment (Days 4 to 5). Antibiogram and serotyping were performed in all isolates as was also the MIC of penicillin. The disappearance and persistence of the initial isolates as well as the appearance of isolates with new serotype or with new antibiotic susceptibility patterns were investigated.. A total of 120 patients were studied: 106 received beta-lactam antibiotics and 14 received azithromycin. Among the initial 76 pneumococcal isolates 63, 37 and 13% were resistant to > or =1, > or =2 and > or =3 antibiotic drugs. After 3 to 4 days of treatment with various beta-lactam drugs, 45, 63 and 100% of isolates with MIC values of <0.1 microg/ml, 0.125 to 0.25 microg/ml and 0.38 to 1.0 microg/ml, respectively, persisted in the NP (P = 0.038). There was a difference between the various beta-lactam drugs in their effect on NP colonization: a drug with lower MIC values (cefuroxime-axetil) had a better eradication rate of penicillin-susceptible organisms than a less active one (cefaclor), but neither significantly reduced carriage of penicillin nonsusceptible isolates. Azithromycin eliminated carriage of macrolide-susceptible organisms but increased the carriage of macrolide-resistant ones. In 19 of 120 (16%) patients a new S. pneumoniae isolate was recovered 3 to 4 days after initiation of treatment. Of those 16 (84%) were resistant to the drug the patient was receiving.. A rapid selection of nonsusceptible NP pneumococcal isolates during antibiotic treatment for AOM is common. This phenomenon may contribute to the spread of resistant pneumococci.

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Carrier State; Child, Preschool; Drug Resistance, Microbial; Female; Humans; Infant; Lactams; Male; Microbial Sensitivity Tests; Nasopharynx; Otitis Media; Pneumococcal Infections; Prospective Studies; Streptococcus pneumoniae

Topics: Acute Disease; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Bronchitis; Humans; Virus Diseases

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Azithromycin; Cholestasis, Intrahepatic; Humans; Male

The activities of therapeutic regimens with azithromycin (AZI) and doxycycline combined with streptomycin (DOX-SM) were compared in Brucella melitensis infected mice. In a chronic model, AZI given over 10, 14 or 21 consecutive days (50 mg/kg/24 h) significantly reduced the infection (1.3-1.6 logs, day 48 post-infection). However, the effectiveness of DOX (21 days, 50 mg/kg/12 h) was higher than AZI (3.4 logs of reduction, day 48 post-infection). Besides, when DOX was administered for 45 days, it "cured" all the animals from day 78. Similar results were obtained in an acute model infection. One single dose of DOX or DOX-SM, starting one day after lethal challenge, was able to protect 83% of the mice. In contrast, only 25% of the mice treated with AZI (50-200 mg/Kg) survived the challenge. Our findings demonstrate that AZI, in contrast to DOX-SM, does not cure experimental brucellosis.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Azithromycin; Brucella melitensis; Brucellosis; Chronic Disease; Colony Count, Microbial; Doxycycline; Drug Combinations; Female; Mice; Spleen; Streptomycin

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Azithromycin; Bacteremia; Disease Models, Animal; Lung; Mice; Pneumonia, Pneumococcal; Respiratory Tract Infections; Tissue Distribution

The activities of a short therapeutic regimen with azithromycin and the classic treatment doxycycline with streptomycin were compared and evaluated in mice infected with Brucella melitensis. In a chronic model, starting therapy 31 days after challenge, azithromycin (10 days, 50 mg/kg/day) significantly reduced the infection (2.9 logs, day 48 post-infection). The effectiveness of doxycycline (21 days, 50 mg/kg/12 hourly) was greater than azithromycin (4.1 logs of reduction, day 48 post-infection), and when doxycycline was administered for a period of 45 days, all the animals were bacteriologically cured from day 78. The combination with streptomycin (14 days, 10 mg/kg/day) did not improve the effect of any of the regimens. In an acute model infection, treatments with doxycycline or doxycycline-streptomycin, for a period of 3 days, starting 1 day after lethal challenge, were able to protect all the mice. In contrast, only 50% of the mice treated with azithromycin survived the challenge. In conclusion, although a short oral treatment with azithromycin was able to reduce the infection significantly, it was not able to cure the animals as effectively as the classic regimen with doxycycline administered for a longer period of time.

Topics: Acute Disease; Animals; Anti-Bacterial Agents; Azithromycin; Brucella abortus; Brucella melitensis; Brucellosis; Chronic Disease; Doxycycline; Drug Therapy, Combination; Female; Mice; Mice, Inbred BALB C; Organ Size; Spleen; Streptomycin

Azithromycin activity in vivo has been studied in a group of children with acute respiratory tract infections in order to test the efficacy and tolerability of this antibiotic. The study involved 135 children treated with a single daily 10 mg/kg dose of azithromycin for three consecutive days. Ten days after this treatment 100% of children with otitis media, tracheobronchitis, or rhinosinusitis and 95.9% of children with pharyngo-tonsillitis were cured. Recurrences were never observed. Azithromycin proved remarkably effective for treatment of acute respiratory infections and otitis media in children. Tolerability and therapeutic compliance were excellent.

Topics: Acute Disease; Azithromycin; Bacteria; Bronchitis; Child; Child, Preschool; Evaluation Studies as Topic; Female; Humans; Infant; Male; Otitis Media; Pharyngitis; Respiratory Tract Infections; Rhinitis; Sinusitis; Tonsillitis; Tracheitis

Topics: Acute Disease; Adult; Azithromycin; Erythromycin; Humans; Male; Nephritis, Interstitial; Respiratory Tract Infections

The concentrations of azithromycin in sinus fluid and mucosal tissue were determined in a total of 23 patients with acute or chronic sinusitis. Five patients with acute sinusitis and four with chronic sinusitis were administered a five-day course of oral azithromycin (500 mg on day 1, 250 mg on days 2-5, all as single doses), and the remaining 14 patients, all with chronic sinusitis, received single oral doses of azithromycin (500 mg). With the five-day regimen, the mean levels of azithromycin in sinus fluid were markedly higher in patients with acute sinusitis (1.34 micrograms/ml) than in patients with chronic sinusitis (0.25 micrograms/ml) 24 h after the first dose. The levels of azithromycin in the sinus fluid increased from the first to the last dose in both patient groups; the mean levels of azithromycin 24 h after the last dose were 2.33 micrograms/ml in acute sinusitis patients and 0.38 micrograms/ml in chronic sinusitis patients. In chronic sufferers, the mean levels of azithromycin in the sinus fluid following a single oral dose were 0.25, 0.41, 0.57 and 0.22 micrograms/ml at 24, 48, 72 and 96 h, respectively, after administration. In these patients the mean sinus drug concentrations were much greater in the mucosal tissue (1.23 micrograms/g) than in the sinus fluid (0.41 micrograms/ml) 48 h after administration of the single dose. There were no treatment-related changes in laboratory function tests, and side effects were described as mild to moderate (five patients complained of nausea, abdominal pain or headache).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Administration, Oral; Adult; Aged; Azithromycin; Body Fluids; Chronic Disease; Drug Administration Schedule; Erythromycin; Female; Humans; Male; Maxillary Sinusitis; Middle Aged; Nasal Mucosa

A group of 21 patients admitted to hospital with acute purulent exacerbations of chronic bronchitis was treated for five days with a new oral macrolide azithromycin. They received one dose of 500 mg on the first day, followed by 250 mg once daily thereafter. Pre-treatment sputum cultures were typical for this district, but the cultures during and after treatment showed many Haemophilus influenzae infections persisting. Geometric mean MICs of azithromycin for these organisms rose from 1.23 mg/l (pre-treatment) to 4.87 mg/l, a week after the end of treatment. The mean MICs for erythromycin also rose four-fold. Streptococcus pneumoniae and Branhamella catarrhalis strains were effectively eradicated. Pharmacokinetic studies on serum and sputum from the first treatment day showed relatively low serum Cmax values, averaging 0.63 mg/l, but with considerable individual variation. However, peak sputum concentrations averaged 3.7 mg/l. Nevertheless, the clinical and microbiological results were not encouraging because of the failure to eradicate H. influenzae with the drug dosage used in this study.

Topics: Acute Disease; Aged; Aged, 80 and over; Azithromycin; Bronchitis; Erythromycin; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Sputum; Time Factors

The efficacy of an investigational macrolide, azithromycin, in the treatment of acute otitis media consequent to an infection by a strain of beta-lactamase-producing Haemophilus influenzae, was evaluated using the chinchilla animal model. The results indicate that the azithromycin high-dosage (30 mg/kg/d) group has a significantly higher rate for effusion sterilization and resolution as compared with the other treatment groups. Unique pharmacokinetic properties of this investigational antimicrobial were demonstrated. Clinical trials using azithromycin for the treatment of upper respiratory tract infections, including otitis media, are warranted.

Topics: Acute Disease; Ampicillin; Animals; Azithromycin; Chinchilla; Disease Models, Animal; Erythromycin; Haemophilus Infections; Haemophilus influenzae; Otitis Media