Comparison of the clinical and microbiologic efficacy of single-dose ceftibuten, 3-dose ceftibuten, and 7-day trimethoprim/sulfamethoxazole in the treatment of uncomplicated cystitis

A randomized, prospective, comparative, unmasked, 3-arm clinical trial was conducted to assess the efficacy of 2 short courses of ceftibuten in the tr eatment of uncomplicated cystitis. The study patients were ambulatory women greater than or equal to 18 years of age with acute lower urinary tract in fection corroborated by positive urine culture. Pregnant or nursing women w ere excluded from the study. Patients were assigned randomly to receive 1 o f the following regimens: (I) ceftibuten, one 400-mg dose, orally; (2) ceft ibuten, 400-mg, orally once daily for 3 days; and (3) trimethoprim/sulfamet hoxazole (TMP/SMX), 160/800 mg, orally twice daily for 7 days. The patients were assessed 7 to 10 days and 21 to 28 days after the end of treatment. S ixty patients entered the study, 20 in each treatment group. The cure rate in the group treated with 3 doses of ceftibuten was 95%, with TMP/SMX 90%, and with single-dose ceftibuten 70%. Statistical analysis showed a signific ant difference between the results with the first 2 treatment regimens vers us the single-dose ceftibuten regimen. All treatments were well tolerated b y the patients, with no reports of adverse reactions. Results of the presen t study suggest that 3-dose ceftibuten is an adequate alternative for the t reatment of acute uncomplicated cystitis.