Seven vs. 14 Days Treatment for Male Urinary Tract Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01994538|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 28, 2020
Last Update Posted : October 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Other: Longer therapy duration Other: Shorter therapy duration||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||273 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Seven Versus Fourteen Day Treatment for Male Urinary Tract Infection|
|Actual Study Start Date :||April 24, 2014|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Active Comparator: Longer (14 day) duration antimicrobial treatment
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Other: Longer therapy duration
14 days of antimicrobial treatment
Placebo Comparator: Shorter (7 day) duration antimicrobial treatment
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Other: Shorter therapy duration
7 days of antimicrobial treatment
- Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy [ Time Frame: 14 days ]This outcome will be assessed in a binary manner. Subjects with persistent UTI symptoms or having received further antimicrobials because of UTI symptoms will be considered to have not met the primary outcome, whereas those without persistent UTI symptoms and not having received further antimicrobials will be considered to have met the primary outcome.
- Recurrent UTI Within 28 Days of Completing Active Study Medication [ Time Frame: 28 days ]New onset of symptomatic UTI within the 28 day follow-up period
- Adverse Drug Event in the 28 Days After Completing Study Medication [ Time Frame: 28 days ]
The incidence of adverse drug events, including nausea, vomiting, diarrhea, dizziness, headache, drug allergy, and C. difficile infection, both individually and in aggregate, will be compared between treatment groups
This outcome is number of subjects experiencing ANY adverse drug event
- Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli [ Time Frame: 7 days ]Intestinal carriage of antimicrobial-resistant Gram-negative bacilli after completing study medication, as compared to a baseline sample taken early in treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994538
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Dimitri M Drekonja, MD||Minneapolis VA Health Care System, Minneapolis, MN|