Gemifloxacin once daily for 7 days compared to amoxicillin/clavulanic acid thrice daily for 10 days for the treatment of community-acquired pneumonia of suspected pneumococcal origin

Context: Community-acquired pneumonia (CAP) is common among adults and contributes considerably to morbidity and mortality. Objective: To compare the safety and efficacy of gemifloxacin to high-dose amoxicillin/clavulanate for the treatment of CAP of suspected pneumococcal origin. Design: Randomized, multicentre, double-blind, double-dummy, parallel group Phase III study. Setting and participants: From September 1998 to July 1999, 324 patients with CAP were randomized at 102 centers in France, Poland and the Republic of South Africa. Intervention: Patients were double-blind randomized to receive either oral gemifloxacin 320 mg once daily for 7 days or oral amoxicillin/clavulanate 1 g/1 25 mg three times daily for 10 days. Main outcome measures: The main outcome measures were clinical, bacteriotogical, and radiological responses at the end of therapy (day 12-14) and follow-up (day 24-30) visits. Results: In 228 PP patients, clinical resolution at follow-up was 88.7% for 7-day gemifloxacin and 87.6% for 10-day amoxicillin/clavulanate [95% CI, -7.3, 9.5]. In 249 PP patients, clinical resolution at end of therapy was 95.3% for 7-day gemifloxacin vs. 90.1% for 10-day amoxicillin/clavutanate [95% Cl, -1.2, 11.7]. Bacteriologic response rates for the PP patients at end of therapy were 96.3% for 7-day gernifloxacin and 91.8% for the amoxicillin/clavulanate group [95% Cl, -4.7, 13.6]. Bacteriologic response rates at follow-up were 87.2% for 7-day gernifloxacin and 89.1% for the amoxicillin/clavulanate group [95% CI, -15.0, 11.2]. Specifically gernifloxacin eradicated 95.7% of Streptococcus pneumoniae including penicillin and macrolide resistant strains. Radiological response rates for the PP patients at end of therapy were 89.1% for 7-day gemifloxacin and 87.6% for the amoxicillin/clavulanate group. The most frequently reported drug-retated events were in the gernifloxacin group, diarrhea (6.0%) and rash (3.0%) and in the amoxicillin/clavulanate group, diarrhea (11.1%) and fungal infection, vaginitis and vomiting (each 2.0%). Overall there were statistically fewer withdrawals due to tack of therapeutic effect in the gemifloxacin group compared with the amoxicillin/clavulanate cohort, (95% Cl, -8.8;0.6; P = 0.03). Conclusion: Gemifloxacin 320 mg once daily for 7 days was found to be clinically, bacteriologically, and radiologically as effective as 10 days of amoxicillin/clavulanate 1 g/125 mg three times daily for the treatment of suspected pneumococcal CAR (C) 2004 Elsevier Ltd. All rights reserved.