Importance: Determination of optimal treatment durations for common infectious diseases is an important strategy to preserve antibiotic effectiveness.
Objective: To determine whether 7 days of treatment is noninferior to 14 days when using ciprofloxacin or trimethoprim/sulfamethoxazole to treat urinary tract infection (UTI) in afebrile men.
Design, Setting, and Participants: Randomized, double-blind, placebo-controlled noninferiority trial of afebrile men with presumed symptomatic UTI treated with ciprofloxacin or trimethoprim/sulfamethoxazole at 2 US Veterans Affairs medical centers (enrollment, April 2014 through December 2019; final follow-up, January 28, 2020). Of 1058 eligible men, 272 were randomized.
Interventions: Participants continued the antibiotic prescribed by their treating clinician for 7 days of treatment and were randomized to receive continued antibiotic therapy (n = 136) or placebo (n = 136) for days 8 to 14 of treatment.
Main Outcomes and Measures: The prespecified primary outcome was resolution of UTI symptoms by 14 days after completion of active antibiotic treatment. A noninferiority margin of 10% was selected. The as-treated population (participants who took ≥26 of 28 doses and missed no more than 2 consecutive doses) was used for the primary analysis, and a secondary analysis included all patients as randomized, regardless of treatment adherence. Secondary outcomes included recurrence of UTI symptoms and/or adverse events within 28 days of stopping study medication.
Results: Among 272 patients (median [interquartile range] age, 69 [62-73] years) who were randomized, 100% completed the trial and 254 (93.4%) were included in the primary as-treated analysis. Symptom resolution occurred in 122/131 (93.1%) participants in the 7-day group vs 111/123 (90.2%) in the 14-day group (difference, 2.9% [1-sided 97.5% CI, -5.2% to ∞]), meeting the noninferiority criterion. In the secondary as-randomized analysis, symptom resolution occurred in 125/136 (91.9%) participants in the 7-day group vs 123/136 (90.4%) in the 14-day group (difference, 1.5% [1-sided 97.5% CI, -5.8% to ∞]) Recurrence of UTI symptoms occurred in 13/131 (9.9%) participants in the 7-day group vs 15/123 (12.9%) in the 14-day group (difference, -3.0% [95% CI, -10.8% to 6.2%]; P = .70). Adverse events occurred in 28/136 (20.6%) participants in the 7-day group vs 33/136 (24.3%) in the 14-day group.
Conclusions and Relevance: Among afebrile men with suspected UTI, treatment with ciprofloxacin or trimethoprim/sulfamethoxazole for 7 days was noninferior to 14 days of treatment with regard to resolution of UTI symptoms by 14 days after antibiotic therapy. The findings support the use of a 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole as an alternative to a 14-day course for treatment of afebrile men with UTI.
Trial Registration: ClinicalTrials.gov identifier: NCT01994538.
|Original language||English (US)|
|Number of pages||8|
|Journal||JAMA - Journal of the American Medical Association|
|State||Published - Jul 27 2021|
Bibliographical noteFunding Information:
Funding/Support: The study was funded by the VA Merit Review Program, grant number I01BX007080. Dr Trautner’s work is supported in part by a grant from the Houston VA Health Services Research & Development Center for Innovations in Quality, Effectiveness, and Safety (CIN 13-413).
© 2021 American Medical Association. All rights reserved.
- Anti-Bacterial Agents/administration & dosage
- Ciprofloxacin/administration & dosage
- Double-Blind Method
- Drug Administration Schedule
- Duration of Therapy
- Middle Aged
- Trimethoprim, Sulfamethoxazole Drug Combination/administration & dosage
- Urinary Tract Infections/drug therapy
PubMed: MeSH publication types
- Equivalence Trial
- Research Support, Non-U.S. Gov't
- Randomized Controlled Trial
- Multicenter Study
- Pragmatic Clinical Trial
- Journal Article
- Comparative Study