Single dose pefloxacin compared with multiple dose co-trimoxazole in cystitis

Abstract

In a double-blind multicentre study the efficacy and safety of a single-dose treatment with pefloxacin (800 mg) was compared with a five-day treatment regimen of 960 mg co-trimoxazole twice daily in the therapy of acute uncomplicated cystitis in women. In order to maintain blindness, patients in the pefloxacin group received placebo to complement the full number of tablets. Nine centres were involved; 155 patients received pefloxacin and 161 patients received co-trimoxazole. Of these, 140 patients treated with pefloxacin and 145 with co-trimoxazole were considered valid for efficacy and safety analysis. At the first follow-up, after seven to ten days, 97.1% of the pefloxacin group and 95.2% of the co-trimoxazole group were bacteriologically cured. At the second follow-up visit, after 28 to 42 days, the urine culture was negative in 95.0% of the pefloxacin group and 90.3% of the co-trimoxazole group. A single dose of 800 mg pefloxacin was demonstrated to be as safe and at least as effective as a five-day regimen of co-trimoxazole in the treatment of uncomplicated cystitis.

Randomized, double-blind comparison of single-dose regimens of rufloxacin and pefloxacin for acute uncomplicated cystitis in women. French Multicenter Urinary Tract Infection-Rufloxacin Group

“…These symptoms were the most common events reported also in a previous study on rufloxacin (21). The type and frequency of adverse events observed with pefloxacin were similar to those in other studies (31,36).…”

“…The bacteriological cure rate obtained with 800 mg of pefloxacin was slightly lower than that obtained in other studies (31,36). One possible explanation is that we adopted more rigorous criteria in the classification of bacteriological outcome.…”

“…Bactericidal concentrations in urine for up to at least 3 days following administration (4, 25, 39) make the long-acting fluoroquinolones adequate and effective for single-dose treatment of uncomplicated cystitis in women (13,31,36). Conversely, some concern has been expressed about single-dose treatment with the conventional fluoroquinolones in that S. saprophyticus infections fail to respond and lead to frequent recurrences (1,10,26,27,34).…”

“…Statistical tests were two-tailed; P values of Յ0.05 were considered statistically significant. Assuming a bacteriological cure rate of 90% with pefloxacin at the late follow-up (31,36), a sample size of 141 bacteriologically assessable patients per group at the late follow-up was needed in order to be 95% confident that rufloxacin is at worst 10% inferior to pefloxacin, with 80% power (18). Assuming that an estimated 30% of randomized patients would be excluded from the per-protocol analysis because of failure in fulfilling inclusion criteria and a further 10% would be excluded because of missed posttreatment visits, a total of 470 patients were planned to be enrolled in the study (22).…”

“…The long-acting fluoroquinolones, allowing single-dose treatment, have further contributed to the treatment of this urinary infection (29,34,37). Single doses of pefloxacin and fleroxacin have been used successfully (13,31,36). They are the only fluoroquinolones approved for use in European countries or in the United States as single-dose treatment for this indication.…”