A controlled, double-blind, multicenter study comparing clarithromycin extended-release tablets and levofloxacin tablets in the treatment of community-acquired pneumonia.

BACKGROUND: Macrolides and fluoroquinolones are frequently used for the empiric treatment of community-acquired pneumonia (CAP). OBJECTIVE: The aim of the study was to compare the safety profile and efficacy of clarithromycin extended-release (ER) tablets with those of levofloxacin tablets for the treatment of CAP in ambulatory adult patients. METHODS: In a Phase III, double-blind, randomized, parallel-group, multicenter study, ambulatory adult patients (> or = 18 years) with signs and symptoms of CAP received a 7-day course of treatment with either clarithromycin ER (two 500-mg tablets once daily) or levofloxacin (two 250-mg tablets once daily). A diagnosis of CAP was confirmed by radiography of the chest and physical examination, and sputum samples were analyzed to identify etiologic pathogen(s). Tolerability was assessed through subjective reports of adverse events and through changes in physical findings, concomitant medications, and laboratory values. RESULTS: There were no statistically significant differences between treatment groups in terms of sex, age, race, or body weight. The mean age was 50 years (range, 18-91 years). Of 299 patients randomized and treated, 252 were clinically evaluable (128 clarithromycin ER, 124 levofloxacin). The 95% CI for the difference between cure rates demonstrated equivalence of the 2 treatments. Among clinically evaluable patients at the test-of-cure visit, clinical cure rates were 88% (113/128) and 86% (107/124), and radiographic success rates were 95% (117/123) and 88% (104/118) for clarithromycin ER and levofloxacin, respectively. Both treatment regimens were effective in resolving and improving clinical signs and symptoms of CAP. Among clinically and bacteriologically evaluable pa- tients, bacteriologic cure rates were 86% (80/93) and 88% (85/97) for clarithromycin ER and levofloxacin, respectively. No statistically significant differences were observed between the 2 treatment groups in the overall incidence of adverse events. CONCLUSIONS: Clarithromycin ER demonstrated equivalent efficacy and tolerability to the fluoroquinolone levofloxacin in a group of ambulatory adult patients with CAP. Clarithromycin ER also appeared to be safe in the population studied.

Parent-reported outcomes for treatment of acute otitis media with cefdinir or amoxicillin/clavulanate oral suspensions.

OBJECTIVE: To compare parent-reported outcomes (satisfaction, tolerability, compliance, and work/daycare missed) for children (aged 6 months to 6 years) receiving either cefdinir or amoxicillin/clavulanate for acute otitis media. METHOD: In a phase IV, investigator-blinded, parallel-group, randomized, multicenter study, parents or legal guardians were asked to complete the Otitis Parent Questionnaire (OPQ) 12-14 days after the first dose of cefdinir or amoxicillin/clavulanate oral suspensions. Responses in each of the outcome domains were analyzed using non-parametric statistical analysis. RESULTS: Of 367 parents/guardians who completed the questionnaire, better ease of use (p = 0.009) and taste (p < 0.0001) were associated with cefdinir versus amoxicillin/clavulanate treatment, and children were significantly more likely to experience vomiting with amoxicillin/clavulanate (16% vs 8%; p = 0.016). Parents also reported that their children were much more likely to take all of their medication if receiving cefdinir (68% vs 53% for amoxicillin/clavulanate; p = 0.005). There were no statistically significant differences between groups in work/daycare missed. CONCLUSION: Based on parents' assessment using the OPQ, cefdinir was easier to administer and tasted better than amoxicillin/clavulanate. Children who received cefdinir also experienced less vomiting and had greater compliance than children who received amoxicillin/clavulanate.

Overview of cefdinir: pharmacokinetics, safety, and efficacy in the treatment of uncomplicated skin and skin structure infections.

Uncomplicated skin and skin structure infections commonly are caused by Staphylococcus aureus and Streptococcus pyogenes. Cefdinir, an extended spectrum, third-generation cephalosporin is a safe and effective means of treating skin infections caused by these organisms, as well as many gram-negative pathogens. This article summarizes the pharmacokinetics, dosing schedule, adverse event profile, and efficacy data for cefdinir in adult and pediatric, populations in the treatment of uncomplicated skin and skin structure infections.