Trial record 6 of 93 for:    Open Studies | "Urinary Tract Infections"

Seven vs. 14 Days Treatment for Male Urinary Tract Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01994538
First received: November 19, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

This study will investigate the treatment of urinary tract infection in men. Specifically, we are looking to see if shorter duration of antibiotics (7 days) is any worse than longer duration of antibiotics (14 days). We 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.


Condition Intervention
Urinary Tract Infections
Other: Longer therapy duration
Other: Shorter therapy duration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Seven vs. 14 Days Treatment for Male Urinary Tract Infection

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Resolution of UTI symptoms 14 days after completing active antimicrobial therapy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Recurrent UTI within 28 days of completing active study medication [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    New onset of symptomatic UTI within the 28 day follow-up period

  • Adverse drug event in the 28 days after completing study medication [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The incidence of adverse drug events, including nausea, vomiting, diarrhea, dizziness, headache, drug allergy, and C. difficile infection, both individually and in aggregate, will be compared between treatment groups

  • Intestinal carriage of antimicrobial-resistant Gram negative bacilli [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Intestinal carriage of antimicrobial-resistant Gram-negative bacilli after completing study medication, as compared to a baseline sample taken early in treatment.


Estimated Enrollment: 319
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Longer (14 day) duration antimicrobial treatment
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Other: Longer therapy duration
14 days of antimicrobial treatment
Placebo Comparator: Shorter (7 day) duration antimicrobial treatment
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Other: Shorter therapy duration
7 days of antimicrobial treatment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994538

Contacts
Contact: Dimitri M Drekonja, MD Dimitri.Drekonja@va.gov

Locations
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Wanda E Hodnefield, RN    612-467-2804    Wanda.Hodnefield@va.gov   
Contact: Hanna E Bloomfield, MD MPH    (612) 467-2682    hanna.bloomfield@va.gov   
Principal Investigator: Dimitri M. Drekonja, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Dimitri M. Drekonja, MD Minneapolis VA Health Care System, Minneapolis, MN
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01994538     History of Changes
Other Study ID Numbers: CLIN-008-13S, I01BX007080
Study First Received: November 19, 2013
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Urinary Tract Infections
Urinary antiinfective agents

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Infective Agents
Anti-Infective Agents, Urinary
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on July 24, 2014