Clinical trial NCT01994538: Seven vs. 14 Days Treatment for Male Urinary Tract Infection
Official title: Seven Versus Fourteen Day Treatment for Male Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Urinary Tract Infections
Urinary antiinfective agents
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-11-25
Enrollment: 273
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the treatment of urinary tract infection in men. Specifically, the investigators are looking to see if shorter duration of antibiotics (7 days) is any worse than longer duration of antibiotics (14 days). The investigators will also study whether longer treatment leads to an increase in antibiotic resistant bacteria in the large intestine (colon), or an increase in drug side effects.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Must have all

* Male gender
* New-onset (within 7 days) of at least one of the following symptoms/findings: dysuria, urinary frequency, urgency, hematuria, perineal pain, supra-pubic pain, costovertebral angle tenderness, or flank pain
* Treated as an outpatient (Primary Care Center or Emergency Department), with \< 24 hours observation in the hospital or Emergency Department following the time of initial diagnosis
* Prescribed treatment with at least 7 days, but not more than 14 days, of either ciprofloxacin or TMP-SMZ

Exclusion Criteria:

Must have none

* Admission to the hospital (for \> 24h) at the time of diagnosis
* Documented fever at time of initial evaluation ( 38.0 Celsius)
* Previous enrollment in the study
* Treatment for UTI in past 14 days
* Not able to give informed consent
* Unwilling to return for study visit
* Symptoms thought more likely to be caused by a non-UTI diagnosis (e.g., urinary calculus, sexually transmitted infection, etc.)
* Other antimicrobial therapy (new or ongoing) prescribed for a non-UTI diagnosis (e.g., cellulitis, pneumonia, etc.)
* Treatment initiated with an empiric antimicrobial to which the organism isolated in the urine culture is non-susceptible based on standard laboratory criteria
* Treatment initiated with an empiric antimicrobial regimen that is underdosed, based on current guidelines and reviews

Primary outcomes:
measure: Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy
timeFrame: 14 days
Secondary outcomes:
measure: Recurrent UTI Within 28 Days of Completing Active Study Medication
timeFrame: 28 days
measure: Adverse Drug Event in the 28 Days After Completing Study Medication
timeFrame: 28 days
measure: Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli
timeFrame: 7 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Dimitri M Drekonja, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drekonja DM, Trautner B, Amundson C, Kuskowski M, Johnson JR. Effect of 7 vs 14 Days of Antibiotic Therapy on Resolution of Symptoms Among Afebrile Men With Urinary Tract Infection: A Randomized Clinical Trial. JAMA. 2021 Jul 27;326(4):324-331. doi: 10.1001/jama.2021.9899.