Journal of Antimicrobial Chemotherapy, Vol 40, 73-81, Copyright © 1997 by The British Society for Antimicrobial Chemotherapy
B O'Doherty, DA Dutchman, R Pettit and A Maroli
This randomized, multicentre, double-blind, double-dummy study assessed the
efficacy and safety of 7 or 10 day regimens of grepafloxacin, 600 mg od,
compared with amoxycillin, 500 mg tds, in the treatment of
community-acquired pneumonia (CAP). A total of 264 patients were recruited
at 43 centres (127 received grepafloxacin and 137 received amoxycillin), of
whom 207 patients (78%) completed the study. Clinical and microbiological
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 after the last dose). At
follow-up, patients in the evaluable population treated 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 documented bacterial pathogen, the
clinical success rate in the grepafloxacin group (78%, 29/37) was
significantly higher than in the amoxycillin group (58%, 28/48), 95% CI =
2%, 43%). In patients from the evaluable population in whom the pathogens
were documented the clinical success rate favoured grepafloxacin, compared
with amoxycillin (79%, 26/33 versus 63%, 26/42, respectively; 95% CI =
-5.2%, 38.1%). Microbiological eradication with grepafloxacin was
statistically superior to amoxycillin in the evaluable population; the
success rate was 89% (32/36) in the grepafloxacin 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 pneumoniae. The success rates for infections
caused by S. pneumoniae and H. influenzae at follow-up were higher with
grepafloxacin than with amoxycillin. Grepafloxacin was well tolerated, with
a safety profile comparable to that of amoxycillin. The therapeutic
judgement of patients and investigators at the patient's last visit, as
well as the assessment 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 than amoxycillin, 500 mg tds for 7-10 days in achieving a successful
clinical and microbiological response in the treatment of patients with
CAP.
ORIGINAL ARTICLES
Randomized, double-blind, comparative study of grepafloxacin and amoxycillin in the treatment of patients with community-acquired pneumonia
Charlotte Row, Gorey, Co. Wexford, Eire, UK.
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