Treatment of Uncomplicated Cystitis in Women
Treatment of Uncomplicated Cystitis in Women
Trimethoprim/sulfamethoxazole and fluoroquinolone antibiotics are highly effective in the treatment of acute cystitis, but increasing resistance to these antimicrobials has prompted calls for alternative treatment strategies.
To compare the efficacy of a short course of amoxicillin/clavulanate to that of ciprofloxacin in the treatment of acute uncomplicated cystitis in women.
Between July 1998 and May 2002, women aged 18−45 years with dysuria, frequency, and/or urgency were enrolled in a single-blind, randomized trial. Exclusion criteria included pregnancy, evidence of pyelonephritis, urinary tract abnormality, and recent use of systemic or vaginal topical antimicrobials. After an initial assessment, patients were randomized to receive amoxicillin/clavulanate 500 mg/125 mg twice daily or ciprofloxacin 250 mg twice daily, each for 3 days. Patients were evaluated every 2 weeks for 4 months, or until treatment for symptomatic persistent or recurrent urinary tract infection (UTI) was required. At initial and follow-up assessments, urine and vaginal specimens were analyzed for the presence of uropathogens and for antimicrobial susceptibilities. Only women with at least 10 colony-forming units (CFU) of uropathogens per ml of urine at the time of enrollment and who completed at least one follow-up evaluation were included in the analysis.
The primary endpoint was clinical cure, defined as the absence of persistent or recurrent UTI symptoms. Secondary endpoints were microbiologic cure (asymptomatic women with urine cultures of <10 CFU/ml, or symptomatic women with urine cultures of <10 CFU/ml) and vaginal colonization with Escherichia coli.
Of 370 women enrolled in the study, 322 were eligible for analysis, 99% of whom took at least five of the six prescribed doses. Median age for both treatment groups was 22 years (range 18−45 years). Median follow-up was 103 days (range 2−125 days). Overall, 93 (58%) of 160 women treated with amoxicillin/clavulanate were clinically cured, compared with 124 (77%) of 162 women treated with ciprofloxacin (P <0.001). Even among women infected with strains susceptible to amoxicillin/clavulanate, this combination was inferior to ciprofloxacin: 65 (60%) of 109 women taking amoxicillin/clavulanate were clinically cured, compared with 114 (77%) of 149 women taking ciprofloxacin (P = 0.004). Persistent and recurrent UTIs occurred in 8 and 59 women in the amoxicillin/clavulanate group, and in 1 and 37 women in the ciprofloxacin group, respectively. At 2 weeks post-treatment, 118 (76%) of 156 women treated with amoxicillin/clavulanate had a microbiologic cure, compared with 153 (95%) of 161 women treated with ciprofloxacin (P <0.001). Vaginal colonization with E. coli occurred in 58 (45%) of 151 women treated with amoxicillin/clavulanate, compared with 16 (10%) of 153 women treated with ciprofloxacin (P <0.001).
In women with acute uncomplicated cystitis, including those infected with susceptible strains, a 3-day regimen of amoxicillin/clavulanate is less effective than ciprofloxacin.
Trimethoprim/sulfamethoxazole and fluoroquinolone antibiotics are highly effective in the treatment of acute cystitis, but increasing resistance to these antimicrobials has prompted calls for alternative treatment strategies.
To compare the efficacy of a short course of amoxicillin/clavulanate to that of ciprofloxacin in the treatment of acute uncomplicated cystitis in women.
Between July 1998 and May 2002, women aged 18−45 years with dysuria, frequency, and/or urgency were enrolled in a single-blind, randomized trial. Exclusion criteria included pregnancy, evidence of pyelonephritis, urinary tract abnormality, and recent use of systemic or vaginal topical antimicrobials. After an initial assessment, patients were randomized to receive amoxicillin/clavulanate 500 mg/125 mg twice daily or ciprofloxacin 250 mg twice daily, each for 3 days. Patients were evaluated every 2 weeks for 4 months, or until treatment for symptomatic persistent or recurrent urinary tract infection (UTI) was required. At initial and follow-up assessments, urine and vaginal specimens were analyzed for the presence of uropathogens and for antimicrobial susceptibilities. Only women with at least 10 colony-forming units (CFU) of uropathogens per ml of urine at the time of enrollment and who completed at least one follow-up evaluation were included in the analysis.
The primary endpoint was clinical cure, defined as the absence of persistent or recurrent UTI symptoms. Secondary endpoints were microbiologic cure (asymptomatic women with urine cultures of <10 CFU/ml, or symptomatic women with urine cultures of <10 CFU/ml) and vaginal colonization with Escherichia coli.
Of 370 women enrolled in the study, 322 were eligible for analysis, 99% of whom took at least five of the six prescribed doses. Median age for both treatment groups was 22 years (range 18−45 years). Median follow-up was 103 days (range 2−125 days). Overall, 93 (58%) of 160 women treated with amoxicillin/clavulanate were clinically cured, compared with 124 (77%) of 162 women treated with ciprofloxacin (P <0.001). Even among women infected with strains susceptible to amoxicillin/clavulanate, this combination was inferior to ciprofloxacin: 65 (60%) of 109 women taking amoxicillin/clavulanate were clinically cured, compared with 114 (77%) of 149 women taking ciprofloxacin (P = 0.004). Persistent and recurrent UTIs occurred in 8 and 59 women in the amoxicillin/clavulanate group, and in 1 and 37 women in the ciprofloxacin group, respectively. At 2 weeks post-treatment, 118 (76%) of 156 women treated with amoxicillin/clavulanate had a microbiologic cure, compared with 153 (95%) of 161 women treated with ciprofloxacin (P <0.001). Vaginal colonization with E. coli occurred in 58 (45%) of 151 women treated with amoxicillin/clavulanate, compared with 16 (10%) of 153 women treated with ciprofloxacin (P <0.001).
In women with acute uncomplicated cystitis, including those infected with susceptible strains, a 3-day regimen of amoxicillin/clavulanate is less effective than ciprofloxacin.
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