Abstract.
Background: This randomized, double-blind study compared the efficacy and tolerability of the new ketolide antimicrobial telithromycin with that of high-dose amoxicillin in the treatment of community-acquired pneumonia (CAP).
Patients and Methods: Adult patients (n = 404), with signs and symptoms of CAP and radiologic confirmation were randomized to receive telithromycin 800 mg once daily (n = 199) or amoxicillin 1,000 mg three times a day (n = 205) for 10 days. Clinical and bacteriologic outcomes were assessed at post-therapy test-of-cure (days 17–24) and late post therapy (days 31–36).
Results: The clinical cure rate for telithromycin-treated patients (per protocol) pst therapy (days 17–24) was 141/149 (94.6%) and compared well with that for amoxicillin (137/152 (90.1%)). Subset analysis of patients (per protocol) showed high clinical cure rates for patients aged ≥ 65 years (telithromycin 21/24, 87.5%; amoxicillin 22/29, 75.9%); those with documented pneumococcal bacteremia (telithromycin 10/10, 100%; amoxicillin 7/9, 77.8%); and patients with a Fine score ≥ III (telithromycin 31/34, 91.2%; amoxicillin 38/47, 80.9%). Bacterial eradication rates were comparable between treatments (telithromycin 42/48, 87.5%; amoxicillin 39/45, 86.7%), with 22/23 vs 18/21 Streptococcus pneumoniae strains 9/12 vs 11/13 Haemophilus influenzae strains and all Moraxella catarrhalis isolates (five and three patients, respectively) eradicated at the test-of-cure ivsit. Both treatments were generally well tolerated.
Conclusion: Telithromycin 800 mg once daily is a convenient, optimal-spectrum, first-line treatment for CAP in adults, at least as effective and well tolerated as high-dose amoxicillin.
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Received: August 24, 2001 · Revision accepted: July 5, 2002
L. Hagberg (corresponding author)
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Hagberg, L., Torres, A., van Rensburg, D. et al. Efficacy and Tolerability of Once-Daily Telithromycin Compared with High-Dose Amoxicillin for Treatment of Community-Acquired Pneumonia. Infection 30, 378–386 (2002). https://doi.org/10.1007/s15010-002-2096-z
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DOI: https://doi.org/10.1007/s15010-002-2096-z