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March 13, 1995

Short-Course Ciproflox Treatment of Acute Uncomplicated Urinary Tract Infection in Women: The Minimum Effective Dose

Author Affiliations

Central Florida Medical Research Center, Orlando; Infections Limited, PS, Tacoma, Wash; Mercy Hospital, Springfield, Mass; Columbiana (Ala) Associates; Columbia University, New York, NY; The Portland (Ore) Clinic; Metrohealth Medical Center, Cleveland, Ohio; University of New Mexico Hospital, Albuquerque; Duke University Medical Center, Durham, NC; Massachusetts General Hospital, Boston; California Medical Research Group, Fresno; Florida Medical Clinic, Zephyrhills; Florida Health Care Plan Inc, Holly Hills; University of Cincinnati (Ohio) Medical Center; Southeastern Research Foundation, Alabaster, Ala; University of Michigan, Ann Arbor; University of Tennessee College of Medicine, Memphis; Marilyn Hollahan. Wake Research Associates, Raleigh, NC

From the Central Florida Medical Research Center, Orlando (Dr Iravani); Infections Limited PS, Tacoma, Wash (Dr Tice); California Medical Research Group, Fresno (Dr McCarty); East Pasco Specialty Care, Zephyrhills, Fla (Dr Sikes); Columbiana (Ala) Clinic (Dr Nolen); Duke University Medical Center, Durham, NC (Dr Gallis); and Miles Inc Pharmaceutical Division, West Haven, Conn (Drs Whalen, Heyd, Kowalsky, and Echols and Mr Tosiello). Participating centers and investigators are listed in a box at the end of this article.

Arch Intern Med. 1995;155(5):485-494. doi:10.1001/archinte.1995.00430050061007

Background:  Three studies were undertaken to determine the minimum effective dosing regimen of ciprofloxacin for the treatment of acute, symptomatic, uncomplicated lower urinary tract infection.

Methods:  All studies were multicenter, prospective, randomized, double-blind trials. A total of 970 evaluable patients with a diagnosis of urinary tract infection received oral ciprofloxacin (200 mg to 500 mg daily in one or two divided doses for 1, 3, 5, or 7 days) or norfloxacin (400 mg twice daily [BID] for 7 days). The primary measure of efficacy was bacteriologic eradication at the end of therapy.

Results:  In study 1, bacteriologic eradication was reported in 95 (89%) and 101 (98%) of patients in the groups who received ciprofloxacin, 500-mg single dose and 250 mg BID for 7 days, respectively. Clinical success occurred in 101 patients (94%) who received a 500-mg single dose and in 103 patients (100%) who were administered 250 mg BID for 7 days. In study 2, eradication rates in the groups who received ciprofloxacin, 100 mg BID for 3 days, 250 mg BID for 3 days, and 250 mg BID for 7 days, were 98 (93%), 95 (90%), and 98 (93%), respectively. Clinical success was reported in 102 (97%), 105 (100%), and 104 (98%) of the patients, respectively. In study 3, the eradication rates in the groups who received ciprofloxacin in dosages of 500 mg once daily for 3 days and 500 mg once daily for 5 days and norfloxacin in a dosage of 400 mg BID for 7 days were 137 (92%), 134 (90%), and 133 (94%) of the women, respectively. Clinical success was the same (97%) in all three groups. Overall, short-course (either 3- or 5-day) therapy with ciprofloxacin was statistically equivalent to conventional (7-day) therapy with either ciprofloxacin or norfloxacin. Single-dose ciprofloxacin therapy was statistically less effective than conventional treatment.

Conclusions:  Ciprofloxacin at a dosage of 100 mg BID for 3 days was the minimum effective dose for the treatment of uncomplicated urinary tract infection in women.(Arch Intern Med. 1995;155:485-494)