Abstract
The treatment duration of acute uncomplicated pyelonephritis (AUP) is still under debate. As shortening treatment duration could be a means to reduce antimicrobial resistance, we aimed to establish whether 5 days of antibiotic treatment is non-inferior to 10 days in patients with AUP. We performed an open-label prospective randomized trial comparing 5 days to 10 days of fluoroquinolone treatment for AUP. The inclusion criteria were: female patients aged ≥18 years with clinical signs of urinary tract infection, fever >38 °C, and positive urinalysis. Patients were randomized to either 5 or 10 days of fluoroquinolone treatment. Outcome was cure at day 10 and day 30 after the end of treatment. One hundred patients were randomized and 12 were excluded after randomization. The mean ± standard deviation (SD) age was 31.8 ± 11 years old and the mean ± SD temperature was 38.6 ± 0.7 °C. The main bacterium involved was Escherichia coli (n = 86; 97.7%) and 3 (3.4%) patients had a positive blood culture. In the post-hoc analysis, clinical cure 10 days after the end of the treatment was 28/30 (93.3%) in the 5-day arm and 36/38 (94.7%) in the 10-day arm (p = 1.00). At day 30, the clinical cure rate was 23/23 (100%) in the 5-day arm and 20/20 (100%) in the 10-day arm (p = 1.00). The microbiological cure rate was 20/23 (87.0%) in the 5-day arm and 16/20 (80.0%) in the 10-day arm (p = 1.00). The efficacy of 5 days of fluoroquinolone treatment does not seem different from 10 days of treatment for AUP.
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Acknowledgments
The authors thank the patients and Elodie Choisy. The authors also acknowledge Céline Vichot, greatly missed, for her help and dedication to this study.
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The French National Agency for Medicines and Health Products Safety (no. A 8082062), the French Data Protection Agency, and the local ethics committee of Versailles University (Eudract 20086004571-22) approved the study protocol. The study was done in accordance with the ethical principles of the Declaration of Helsinki and the Guidelines for Good Clinical Practice. Written informed consent for participation in the trial was obtained from all patients.
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This study was supported by the French Ministry of Health.
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The authors declare that they have no competing interests.
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Dinh, A., Davido, B., Etienne, M. et al. Is 5 days of oral fluoroquinolone enough for acute uncomplicated pyelonephritis? The DTP randomized trial. Eur J Clin Microbiol Infect Dis 36, 1443–1448 (2017). https://doi.org/10.1007/s10096-017-2951-6
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DOI: https://doi.org/10.1007/s10096-017-2951-6