Journal of Antimicrobial Chemotherapy (1999) 43, Suppl. A, 67-75
© 1999 The British Society for Antimicrobial Chemotherapy
A trial comparing low-dose, short-course ciprofloxacin and standard 7 day therapy with co-trimoxazole or nitrofurantoin in the treatment of uncomplicated urinary tract infection
a Central Florida Medical Research Center, Orlando, FL b The Urology Center of Florida, Ocala, FL c University of Michigan Health Service, Ann Arbor, MI d Synergex Inc., Greenwich, CT e Bayer Corporation, Pharmaceutical Division, West Haven, CT, USA
The study was undertaken to compare the safety and efficacy of twice-daily ciprofloxacin for 3
days with standard 7 day therapy with either co-trimoxazole or nitrofurantoin in the treatment of
women with acute, uncomplicated urinary tract infections (UTI). This multicentre, prospective,
randomized, double-blind trial compared oral ciprofloxacin (100 mg bd) for 3 days with
co-trimoxazole (160/800 mg bd) or nitrofurantoin (100 mg bd) for 7 days. Bacteriological and
clinical evaluations were performed at study entry, during therapy and 4-10 days and 4-6 weeks
after the completion of therapy. The primary efficacy parameter was eradication of the causative
organism 4- 10 days following treatment. Of 713 women enrolled and evaluable for safety, 521
were evaluable for efficacy (168 ciprofloxacin, 174 co-trimoxazole, 179 nitrofurantoin). Escherichia coli (83%) was the most frequently isolated pathogen in all treatment groups.
Bacteriological eradication was reported in 88% of ciprofloxacin patients, 93% of co-trimoxazole
patients and 86% of nitrofurantoin patients. At the 4-6 week follow-up, ciprofloxacin had
statistically significantly higher eradication rates (91%) than co-trimoxazole (79%; 95%
confidence limit (CL) = -20.6%, -3.9%) and nitrofurantoin (82%; 95%
CL = -17.1%, -0.9%). Clinical resolution 4- 10 days after therapy and at
the 4- 6 week follow-up was
similar among the three treatment groups. The overall incidence of treatment-emergent adverse
events was not significantly different (P= 0.093) among the three drug regimens,
althousgh co-trimoxazole was associated with a greater number of adverse events than
ciprofloxacin (P 
0.05). Ciprofloxacin also caused fewer episodes of nausea than
either of the other agents (P 0.01).
* Corresponding address: 615 East Princeton Street, Orlando, FL 32803, USA. Tel: +1-407-898-2811; Fax: +1-407-898-6044.
Current address: Bristol-Myers Squibb, Wallingford, CT, USA.
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