N/A
Completed N=272
Seven vs. 14 Days Treatment for Male Urinary Tract Infection
Source: ClinicalTrials.gov NCT01994538 ↗Enrolled (actual)
272
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy — 111; 122 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy |
111; 122 | — |
| SECONDARY Recurrent UTI Within 28 Days of Completing Active Study Medication |
15; 13 | — |
| SECONDARY Adverse Drug Event in the 28 Days After Completing Study Medication |
29; 26 | — |
| SECONDARY Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli |
4; 4 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01994538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.