Seven vs. 14 Days Treatment for Male Urinary Tract Infection

Completed · Not applicable

Conditions studied: Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT01994538

Run by

VA Office of Research and Development

People needed

273

Starts

2014-04-24

Expected to finish

2019-12-31

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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