Seven vs. 14 Days Treatment for Male Urinary Tract Infection

NCT01994538 | Completed Results DMC

• 2 other identifiers: CLIN-008-13SI01BX007080
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Tract Infections

Keywords

Urinary Tract Infections; Urinary antiinfective agents

Outcome Measures

Primary Outcomes (1)

• Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy

  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.

  14 days

Secondary Outcomes (3)

• Recurrent UTI Within 28 Days of Completing Active Study Medication

  28 days

• Adverse Drug Event in the 28 Days After Completing Study Medication

  28 days

• Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli

  7 days

Study Arms (2)

Longer (14 day) duration antimicrobial treatment

ACTIVE COMPARATOR

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Other: Longer therapy duration

Shorter (7 day) duration antimicrobial treatment

PLACEBO COMPARATOR

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

Other: Shorter therapy duration

Interventions

Longer therapy duration OTHER

14 days of antimicrobial treatment

Longer (14 day) duration antimicrobial treatment

Shorter therapy duration OTHER

7 days of antimicrobial treatment

Shorter (7 day) duration antimicrobial treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study of UTI in men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 34313686 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Goal enrollment was 290; actual enrollment of 273 slightly reduces power to detect minimally clinically significant difference.

Results Point of Contact

• Title: Dimitri Drekonja, MD, MS
• Organization: Minneapolis VA Health Care System

dimitri.drekonja@va.gov

612 467 4183

Study Officials

• Dimitri M Drekonja, MD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: April 24, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 2, 2021
• Results First Posted: October 28, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Anticipate will share data for 2 years after publication of the primary result manuscript
• Access Criteria: Requests will be handled on a case-by-case basis with input from the local privacy officer and IRB.

Locations

US (2)