The proposed study is a randomized placebo-controlled trial of treatment duration for male urinary tract infection (UTI). Specifically, 319 men with a UTI will be randomized to 7 vs. 14 days of antimicrobial treatment. The primary outcome is resolution of UTI symptoms, assessed 14 days after completing active antimicrobial treatment. Secondary outcomes include recurrent UTI in the 4 weeks after treatment, adverse drug events, and intestinal carriage of antimicrobial resistant Gram-negative bacilli. Subjects will be enrolled from the Primary Care Clinic and Emergency Department at the Minneapolis VA Medical Center (MVAMC). Currently, the optimal treatment duration for male UTI is unknown. A clinical trial of 14 vs. 28 days of treatment showed no difference in outcomes, whereas another trial of 3 vs.14 days showed an increase in recurrence with 3 days of treatment. However, current treatment recommendations are to treat men with UTI for 7 to 14 days, and no data exist to favor the shorter or longer duration. Most men with UTI in the VA are treated for more than 7 days, which is associated with a small but significant increase in Clostridium difficile infection. Additionally, other studies of non-UTI infectious diseases have shown that longer-duration treatment leads to increased antimicrobial resistance. Longer- duration treatment is also more costly and inconvenient to patients. Thus, since longer-duration treatment is associated with some adverse outcomes, in order to justify longer-duration treatment thee must be some clinically significant benefit to the extended treatment. Accordingly, the proposed randomized placebo-controlled trial of 319 men with UTI will test the hypothesis that 7 days of antimicrobial treatment is non-inferior for the resolution of UTI symptoms when compared to 14 days of treatment. This study will provide valuable information to VA patients and clinicians regarding a common and understudied clinical decision.

Public Health Relevance

The proposed study will answer an important question regarding urinary tract infection (UTI) in men, namely: how long should a man with a UTI be treated with antimicrobials? Seven days of treatment may lead to less-effective treatment, whereas 14 days of treatment may lead to increased adverse drug events and antimicrobial resistance. More than 2 million men are treated for UTI annually in the U.S., accordingly, the potential public-health implications of this study are substantial. If there is a clinically significant benefit to longer-duration treatment, a sizable proportion of men with UTI are currently being under-treated. Alternatively, if 7 days of treatment is non-inferior to 14 days of treatment, a substantial amount of antimicrobials are prescribed with no identifiable benefit.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01CX000830-01A2
Application #
8625566
Study Section
Clinical Trials (CLIN)
Project Start
2014-01-01
Project End
2017-12-31
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Minneapolis VA Medical Center
Department
Type
DUNS #
071774624
City
Minneapolis
State
MN
Country
United States
Zip Code
55417