SETHI S, BRETON J, WYNNE B; Interscience Conference on Antimicrobial Agents and Chemotherapy (43rd: 2003: Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2003 Sep 14-17; 43: abstract no. L-1592.

University of Buffalo, Buffalo, NY.

BACKGROUND: Chronic bronchitis is common, with high morbidity and mortality. Pharmacokinetically enhanced AMX/CA 2000/125 mg was designed to eradicate isolates of S. pneumoniae with AMX MICs of at least 4 microg/ml, while retaining efficacy against beta-lactamase-producing pathogens. METHODS: Efficacy and safety of AMX/CA 2000/125 mg and AMX/CA 875/125 mg, both given orally bid, were compared in this multicenter, randomized, double-blind study. Patients >/= 40 years of age who met the entry criteria received either AMX/CA 2000/125 mg for 5 days or AMX/CA 875/125 mg for 7 days (intent to treat population). The per-protocol (PP) population excluded patients who violated the protocol to an extent that might affect efficacy assessment. RESULTS: A total of 900 patients were randomized (AMX/CA 2000/125 mg, 443; AMX/CA 875/125 mg, 450), with 7 receiving no study medication. Clinical response at test of cure (TOC, Day 14-23, primary efficacy endpoint) in the PP population (N = 710) was 93.0% (332/357) and 91.2% (322/353) for AMX/CA 2000/125 mg and 875/125 mg, respectively (treatment difference [TD] 1.8; 95% CI -2.2, 5.7). In the PP population, a total of 227 patients had >/= 1 pathogen identified at screening. In these patients, bacteriological success rates at TOC were 76.7% (89/116) and 73.0% (81/111) for AMX/CA 2000/125 mg and 875/125 mg, respectively (TD 3.8; 95% CI -7.5, 15.0). A total of 36.6% (162/443) of AMX/CA 2000/125 mg and 42.4% (191/450) of AMX/CA 875/125 mg patients reported >/= 1 adverse event (AE). The most common AE in both groups was diarrhea, mostly mild to moderate, with no significant difference in incidence between the two groups. CONCLUSIONS: The shorter, 5-day course of AMX/CA 2000/125 mg bid was at least as effective as AMX/CA 875/125 mg bid for 7 days in the treatment of AECB. Both therapies were well tolerated.

Publication Types:

• Meeting Abstracts

Keywords:

• Amoxicillin
• Bronchitis, Chronic
• Clavulanic Acid
• Double-Blind Method
• Humans
• Microbial Sensitivity Tests
• Pneumonia
• Treatment Outcome
• therapy

Other ID:

• GWAIDS0026481

UI: 102266105

From Meeting Abstracts