RANDOMIZED, DOUBLE-BLIND, COMPARATIVE-STUDY OF GREPAFLOXACIN AND AMOXICILLIN IN THE TREATMENT OF PATIENTS WITH COMMUNITY-ACQUIRED PNEUMONIA

This randomized, multicentre, double-blind, double-dummy study assesse d the efficacy and safety of 7 or 10 day regimens of grepafloxacin, 60 0 mg od, compared with amoxycillin, 500 mg tds, in the treatment of co mmunity-acquired pneumonia (CAP). A total of 264 patients were recruit ed at 43 centres (127 received grepafloxacin and 137 received amoxycil lin), of whom 207 patients (78%) completed the study. Clinical and mic robiological efficacy were assessed at the end-of-treatment visit (3-5 days after the last dose) and at the follow-up visit (28-42 days afte r the last dose). At follow-up, patients in the evaluable population t reated with grepafloxacin demonstrated a clinical response rate (76%; 87/114) equivalent to that seen with amoxycillin (74%, 85/111, 95% CI = -12%, 10%) while, in the intent-to-treat population with a documente d bacterial pathogen, the clinical success rate in the grepafloxacin g roup (78%, 29/37) was significantly higher than in the amoxycillin gro up (58%, 28/48), 95% CI = 2%, 43%). In patients from the evaluable pop ulation in whom the pathogens were documented the clinical success rat e favoured grepafloxacin, compared with amoxycillin (79%, 26/33 versus 63%, 26/42, respectively; 95% CI -5.2%, 38.1%). Microbiological eradi cation with grepafloxacin was statistically superior to amoxycillin in the evaluable population; the success rate was 89% (32/36) in the gre pafloxacin group compared with 71% (32/45) for the amoxycillin group ( 95% CI = 2%, 37%). The pathogens most commonly isolated from patients were Haemophilus influenzae, Moraxella catarrhalis and Streptococcus p neumoniae. The success rates for infections caused by S. pneumoniae an d H. influenzae at follow-up were higher with grepafloxacin than with amoxycillin. Grepafloxacin was well tolerated, with a safety profile c omparable to that of amoxycillin. The therapeutic judgement of patient s and investigators at the patient's last visit, as well as the assess ment of individual respiratory signs and symptoms, yielded comparable results with both treatments. The results of this study indicate that grepafloxacin, 600 mg od for 7-10 days, is equivalent to or better tha n amoxycillin, 500 mg tds for 7-10 days in achieving a successful clin ical and microbiological response in the treatment of patients with CA P.