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

Abdollah Iravani, MD; Alan D. Tice, MD; James McCarty, MD; David H. Sikes, MD; Thomas Nolen, MD; Harry A. Gallis, MD; Edward P. Whalen, PhD; Robert L. Tosiello, MS; Allen Heyd, PhD; Steven F. Kowalsky, PharmD; Roger M. Echols, MD; Zohreh Iravani; Susan Seligman, RN; Peter K. Marsh, MD; Philip C. Craven, MD; David W. McEniry, MD; Teri Christiansen, RN; Ira Rice, RN; Scott L. Traub, PharmD; Stanley Glasser, MD; Neal Lakritz, MD; Bernard Oddi, MD; Dorothy Tourville; Harry L. Phillips, MD; Joseph L. Story, MD; Jeanette M. Hutchison; Kimberly Long, RN; Steven A. Kaplan, MD; Carl A. Olsson, MD; Katherine A. Soldo, RN; Richard Dickson, MD; Jonathan Fleischmann, MD; Ronald Quenzer, MD; Christopher Brock; Robert H. Rubin, MD; Yvette Hernon, RN; Dorothy Morse, RN; Sharon Zarcone, LPN; Pat Clark; Janie Barthle, LPN; David Williams, MD; Cheryl Benedict; Jeffery E. Heck, MD; Mary Beth Vonder Meulen, RN; Stacy Childs, MD; Judy Pyron; Caesar Briefer, MD; Janet Newton, RN; Clair E. Cox, MD; Wayne L. Harper, MD; Peg Berry, RN
Arch Intern Med. 1995;155(5):485-494. doi:10.1001/archinte.1995.00430050061007.
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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)


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