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.
Author(s): Iravani A(1), Klimberg I, Briefer C, Munera C, Kowalsky SF, Echols RM.
Affiliation(s): Author information:
(1)Central Florida Medical Research Center, Orlando, USA.
Publication date & source: 1999, J Antimicrob Chemother. , 43 Suppl A:67-75
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, although
co-trimoxazole was associated with a greater number of adverse events than
ciprofloxacin (P < or = 0.05). Ciprofloxacin also caused fewer episodes of nausea
than either of the other agents (P < or = 0.01).
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