Randomized, double-blind study of short-course (5 day) grepafloxacin versus 10 day clarithromycin in patients with acute bacterial exacerbations of chronic bronchitis

• Published in: Journal of antimicrobial chemotherapy 1999-10, Vol.44 (4), p.515-523
• Main Authors: LANGAN, C. E, ZUCK, P, VOGEL, F, MCIVOR, A, PIERZCHALA, W, SMAKAL, M, STALEY, H, MARR, C
• Format: Article
• Language: English
• Subjects: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents - therapeutic use; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Anti-Infective Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Bacteria - isolation & purification; Biological and medical sciences; Bronchitis - drug therapy; Bronchitis - microbiology; clarithromycin; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Double-Blind Method; Female; Fluoroquinolones; grepafloxacin; Haemophilus influenzae; Humans; Male; Medical sciences; Middle Aged; Moraxella catarrhalis; Pharmacology. Drug treatments; Piperazines - administration & dosage; Piperazines - adverse effects; Piperazines - therapeutic use; Streptococcus pneumoniae
• ISSN: 0305-7453; 1460-2091
• DOI: 10.1093/jac/44.4.515

The efficacy and safety of grepafloxacin were compared with clarithromycin in a randomized, double-blind, multicentre clinical trial of 805 patients with acute bacterial exacerbations of chronic bronchitis (ABECB). Patients were randomized to receive grepafloxacin 400 mg od for either 5 (n = 273) or 10 days (n = 268) or clarithromycin 250 mg bd for 10 days (n = 261). Patients were assessed pre-treatment, 3-5 days during treatment, 1-3 days post-treatment and at follow-up (21-28 days post-treatment). The clinical success rates for the evaluable patients were 91% in the 5 day grepafloxacin group, 95% in the 10 day grepafloxacin group and 86% in the clarithromycin group. At follow-up, respective rates were 72%, 81% and 73%. A total of 513 pathogens were isolated from the pre-treatment sputum specimens of 400 (49%) patients. The primary pathogens were Haemophilus influenzae (36% of isolates), Haemophilus parainfluenzae (27%), Moraxella catarrhalis (12%), Streptococcus pneumoniae (11%) and Staphylococcus aureus (3%). Pathogens were eradicated or presumed eradicated at post-treatment in 85%, 91% and 58% of evaluable patients treated with grepafloxacin for 5 days, grepafloxacin 10 days and clarithromycin 10 days, respectively. The eradication rates in both grepafloxacin groups were significantly greater than the clarithromycin group (P