Study Protocol: Seven vs. 14 days treatment for afebrile men with urinary tract infection

Carla Amundson; James Johnson; Barbara Trautner; Dimitri Drekonja

doi:10.1016/j.conctc.2021.100714

Study Protocol: Seven vs. 14 days treatment for afebrile men with urinary tract infection

Contemp Clin Trials Commun. 2021 Jan 16:21:100714. doi: 10.1016/j.conctc.2021.100714. eCollection 2021 Mar.

Authors

Carla Amundson¹, James Johnson^{1

2}, Barbara Trautner^{3

4}, Dimitri Drekonja^{1

2}

Affiliations

¹ Minneapolis Veterans Affairs Health Care System, 1 Veterans Drive, Mail Code 111F, Minneapolis, MN, 55417, USA.
² University of Minnesota Medical School, 420 Delaware St SE, Minneapolis, MN, 55455, USA.
³ Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Blvd, Houston, TX, 77030, USA.
⁴ Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.

Abstract

The optimal treatment duration for men with urinary tract infection (UTI) is poorly defined. Observational data suggests that shorter-duration therapy may perform as well as longer-duration therapy, but trial data are lacking. We present the protocol and methods for a Department of Veterans Affairs-funded trial of seven vs. 14 days of antimicrobial therapy for afebrile men with UTI, with the primary outcome of symptom resolution 14 days after completing active antimicrobial treatment. An optional sub-study will investigate the effect of treatment duration on the intestinal carriage of antimicrobial-resistant microorganisms. Subjects are enrolled after their UTI is diagnosed and treatment initiated, using a combination of in-person and mail enrollment to maximize participation and minimize resource utilization. This trial will provide high-quality evidence to guide the management of a common infectious disease and potentially limit unnecessary antimicrobial use.

Keywords: Antibiotics; Clinical trial; Urinary tract infection.