Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women: A randomized trial

Thomas Hooton, Delia Scholes, Kalpana Gupta, Ann E. Stapleton, Pacita L. Roberts, Walter E. Stamm

Research output: Contribution to journalArticle

100 Citations (Scopus)

Abstract

Context: The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied. Objective: To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure. Design, Setting, and Patients: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 102 colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization. Interventions: Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months. Main Outcome Measures: The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E oli colonization at the 2-week follow-up visit. Results: Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P=.004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001). Conclusions: A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.

Original languageEnglish
Pages (from-to)949-955
Number of pages7
JournalJournal of the American Medical Association
Volume293
Issue number8
DOIs
StatePublished - Feb 23 2005
Externally publishedYes

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Clavulanic Acid
Cystitis
Amoxicillin
Ciprofloxacin
Therapeutics
Outcome Assessment (Health Care)
Escherichia coli
Anti-Bacterial Agents
Health Maintenance Organizations
Sulfamethoxazole Drug Combination Trimethoprim

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women : A randomized trial. / Hooton, Thomas; Scholes, Delia; Gupta, Kalpana; Stapleton, Ann E.; Roberts, Pacita L.; Stamm, Walter E.

In: Journal of the American Medical Association, Vol. 293, No. 8, 23.02.2005, p. 949-955.

Research output: Contribution to journalArticle

Hooton, Thomas ; Scholes, Delia ; Gupta, Kalpana ; Stapleton, Ann E. ; Roberts, Pacita L. ; Stamm, Walter E. / Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women : A randomized trial. In: Journal of the American Medical Association. 2005 ; Vol. 293, No. 8. pp. 949-955.
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abstract = "Context: The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied. Objective: To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure. Design, Setting, and Patients: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 102 colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization. Interventions: Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months. Main Outcome Measures: The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E oli colonization at the 2-week follow-up visit. Results: Clinical cure was observed in 93 (58{\%}) of 160 women treated with amoxicillin-clavulanate compared with 124 (77{\%}) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60{\%}] of 109 women in the amoxicillin-clavulanate group vs 114 [77{\%}] of 149 women in the ciprofloxacin group; P=.004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76{\%}) of 156 women treated with amoxicillin-clavulanate compared with 153 (95{\%}) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45{\%} of women in the amoxicillin-clavulanate group compared with 10{\%} in the ciprofloxacin group had vaginal colonization with E coli (P<.001). Conclusions: A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.",
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T2 - A randomized trial

AU - Hooton, Thomas

AU - Scholes, Delia

AU - Gupta, Kalpana

AU - Stapleton, Ann E.

AU - Roberts, Pacita L.

AU - Stamm, Walter E.

PY - 2005/2/23

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N2 - Context: The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied. Objective: To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure. Design, Setting, and Patients: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 102 colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization. Interventions: Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months. Main Outcome Measures: The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E oli colonization at the 2-week follow-up visit. Results: Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P=.004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001). Conclusions: A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.

AB - Context: The high prevalence of resistance to trimethoprim-sulfamethoxazole and other antimicrobials among Escherichia coli causing acute cystitis in women has led to increased use of alternative antibiotics. One such antibiotic, amoxicillin-clavulanate, has not been well studied. Objective: To compare the efficacy of a 3-day regimen of amoxicillin-clavulanate to that of a 3-day regimen of ciprofloxacin in the treatment of acute cystitis in women. The primary study hypothesis was that the amoxicillin-clavulanate and ciprofloxacin treatment groups would differ in clinical cure. Design, Setting, and Patients: Randomized, single-blind treatment trial of 370 women, aged 18 to 45 years, with symptoms of acute uncomplicated cystitis and a urine culture with at least 102 colony-forming units of uropathogens per milliliter from a university student health center or a health maintenance organization. Interventions: Women were randomly assigned to receive amoxicillin-clavulanate (500 mg/125 mg twice daily) or ciprofloxacin (250 mg twice daily) for 3 days and were followed up for 4 months. Main Outcome Measures: The main outcome measure was clinical cure. Secondary study outcomes of interest were microbiological cure and vaginal E oli colonization at the 2-week follow-up visit. Results: Clinical cure was observed in 93 (58%) of 160 women treated with amoxicillin-clavulanate compared with 124 (77%) of 162 women treated with ciprofloxacin (P<.001). Amoxicillin-clavulanate was not as effective as ciprofloxacin even among women infected with strains susceptible to amoxicillin-clavulanate (65 [60%] of 109 women in the amoxicillin-clavulanate group vs 114 [77%] of 149 women in the ciprofloxacin group; P=.004). The difference in clinical cure rates occurred almost entirely within the first 2 weeks after therapy. Microbiological cure at 2 weeks was observed in 118 (76%) of 156 women treated with amoxicillin-clavulanate compared with 153 (95%) of 161 women treated with ciprofloxacin (P<.001). At this visit, 45% of women in the amoxicillin-clavulanate group compared with 10% in the ciprofloxacin group had vaginal colonization with E coli (P<.001). Conclusions: A 3-day regimen of amoxicillin-clavulanate is not as effective as ciprofloxacin for the treatment of acute uncomplicated cystitis, even in women infected with susceptible strains. This difference may be due to the inferior ability of amoxicillin-clavulanate to eradicate vaginal E coli, facilitating early reinfection.

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