Seven vs. 14 Days Treatment for Male Urinary Tract Infection

NCT ID: NCT01994538

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-24
• Study Completion Date: 2019-12-31

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Longer (14 day) duration antimicrobial treatment

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Group Type: ACTIVE_COMPARATOR

Longer therapy duration

Intervention Type: OTHER

14 days of antimicrobial treatment

Shorter (7 day) duration antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Group Type: PLACEBO_COMPARATOR

Shorter therapy duration

Intervention Type: OTHER

7 days of antimicrobial treatment

Interventions

Longer therapy duration

14 days of antimicrobial treatment

Intervention Type: OTHER

Shorter therapy duration

7 days of antimicrobial treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitri M Drekonja, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34313686 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I01BX007080

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CLIN-008-13S

Identifier Type: -

Identifier Source: org_study_id