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.
BACKGROUND
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.


METHODS
Randomized, multicentre, double-blind, double-dummy, parallel group Phase III study.


METHODS
From September 1998 to July 1999, 324 patients with CAP were randomized at 102 centers in France, Poland and the Republic of South Africa.


METHODS
Patients were double-blind randomized to receive either oral gemifloxacin 320 mg once daily for 7 days or oral amoxicillin/clavulanate 1 g/125 mg three times daily for 10 days.


METHODS
The main outcome measures were clinical, bacteriological, 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/clavulanate [95% CI, -1.2, 11.7]. Bacteriologic response rates for the PP patients at end of therapy were 96.3% for 7-day gemifloxacin and 91.8% for the amoxicillin/clavulanate group [95% CI, -4.7, 13.6]. Bacteriologic response rates at follow-up were 87.2% for 7-day gemifloxacin and 89.1% for the amoxicillin/clavulanate group [95% CI, -15.0, 11.2]. Specifically gemifloxacin 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-related events were in the gemifloxacin 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 lack of therapeutic effect in the gemifloxacin group compared with the amoxicillin/clavulanate cohort, (95% CI, -8.8;0.6; P = 0.03).


CONCLUSIONS
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 CAP.
Hôpital Larrey, TSA 30300, 24 Chemin de Pouvourville, 31059 Toulouse, Cedex 9, France. leophonte.p@chu-toulouse.fr
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019818:Clavulanic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D000077735:Gemifloxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011018:Pneumonia, Pneumococcal / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D019818:Clavulanic Acid; D000658:Amoxicillin; D000077735:Gemifloxacin