HAGBERG L, TORRES A, VAN RENSBURG DJ, LEROY B, MANICKAM R, RUUTH E; Interscience Conference on Antimicrobial Agents and Chemotherapy.

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 490.

Sahlgrenska Univ., Goteborg, Sweden

Objectives: Telithromycin (TEL), a new ketolide antimicrobial, has been developed for the empiric treatment of community-acquired respiratory tract infections. This double-blind, parallel-group study compared the efficacy of TEL with high-dose amoxicillin (AMX) in the treatment of community-acquired pneumonia (CAP).METHODS: Adults (n=404; median age 42.0 years, with 73 patients [pts] aged >/= 65) with mild (n=150) or moderate (n=253) CAP as assessed by the investigators, and radiological confirmation were randomized to receive TEL 800 mg once daily (od) (n=199) or AMX 1000 mg three-times daily (n=205) for 10 days. 111 patients had a FINE score >/= 3. Clin. and bacteriological outcomes were assessed at post-therapy (Days 17-21) and late post-therapy (Days 31-36) visits. Indeterminate cases were classed as failures in the modified intent-to-treat (mITT) population which included those pts with a confirmed diagnosis of CAP who received at least 1 dose of study medication.RESULTS: Equivalence in clinical outcome was demonstrated between treatments at post-therapy in both the per protocol (PP) [94.6% TEL vs 90.1% AMX; difference 4.5%, 95% CI: -2.1-11.1%] and mITT [85.9% TEL vs 78.5% AMX; difference 7.4%, 95% CI: -0.5-15.3%] populations. S.pneumoniae was the most commonly isolated causative pathogen in both groups (TEL 32/71 isolates, AMX 34/73 isolates). Eradication rates were also comparable (87.5% for TEL and 86.7% for AMX) at post-therapy (PP). Of the pts with documented pneumococcal bacteremias, 10/10 achieved clinical cure in the TEL group compared with 7/9 in the AMX group. Both treatments were generally well tolerated.CONCLUSIONS: TEL 800 mg od offers a convenient first-line empiric treatment for CAP, at least as effective and well tolerated as high-dose AMX.KEYWORDS: Ketolide; Pneumonia; Telithromycin

Publication Types:

• Meeting Abstracts

Keywords:

• Adult
• Amoxicillin
• Anti-Infective Agents
• Community-Acquired Infections
• Double-Blind Method
• Humans
• Ketolides
• Macrolides
• Pneumonia
• Streptococcal Infections
• administration & dosage
• telithromycin
• therapy

Other ID:

• GWAIDS0011504

UI: 102249002

From Meeting Abstracts