A 7-day course of ofloxacin is inferior to a 14-day course for the treatment of febrile urinary tract infection (UTI) in men. These study results were published in Clinical Infectious Diseases.
Between March 2015 and April 2019, researchers conducted a randomized, double-blinded, placebo-controlled, non-inferiority trial at 27 centers in France. The researchers compared outcomes among men with febrile UTI who were randomly assigned to receive antibiotic therapy for either 7 or 14 days. The primary endpoint was treatment success, defined as testing negative for infection via urine culture and the absence of fever at 6 weeks following treatment initiation.
All patients began treatment on day 1 with either ofloxacin or a third-generation cephalosporin, after which they were randomly assigned to either continue treatment through day 14 or switch to placebo at days 8 through 14. Gail and Simon statistics were used to analyze subset interactions for to determine significant predictors of treatment success.
Among patients in the 7- (n=115) and 14-day (n=125) treatment groups included in the intention-to-treat analysis, the median age was 60.4 years, 17.4% and 8.0% had obesity, 10.4% and 6.4% were immunosuppressed, 11.3% and 4.8% had chronic kidney disease, and 24.3% and 16.0% had diabetes, respectively. Overall, benign prostatic hyperplasia was the most common urologic-related comorbidity among the patients (21.3%), followed by prior UTI (10.8%). Escherichia coli was the most commonly isolated uropathogen among patients in both the 7- and 14-day treatment groups (91.3% vs 77.6%, respectively).
Treatment success was noted in 64 (55.7%) patients in the 7-day treatment group and 97 (77.6%) of those in the 14-day treatment group (risk difference, -21.9; 95% CI,-33.3 to -10.1). Similar results were observed among the per-protocol population.
In multivariable logistic regression models, significant predictors of treatment success included 14 vs 7 days of antibiotic therapy (odds ratio [OR], 0.4; 95% CI, 0.2-0.7; P =.002) and being younger vs older than 50 years (OR, 0.4; 95% CI, 0.2-0.9; P =.023).
Adverse events during treatment were reported by 4 (3.5%) and 7 (5.6%) patients in the 7- and 14-day treatment groups, respectively (P =0.54).
Limitations of this study include potentially insufficient power and imbalances in baseline patient characteristics between the treatment groups.
Based on these findings, “[W]e would not advise to treat males with febrile urinary infection for less than 14 days,” the researchers concluded.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Lafaurie M, Chevret S, Fontaine J-P, et al. Antimicrobial for 7 or 14 days for febrile urinary tract infection in men: a multicenter noninferiority double blind placebo-controlled, randomized clinical trial. Clin Infect Dis. Published online February 14, 2023. doi:10.1093/cid/ciad070