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Seven vs. 14 Days Treatment for Male Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT01994538
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 28, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE October 2, 2020
Results First Posted Date  ICMJE October 28, 2020
Last Update Posted Date October 28, 2020
Actual Study Start Date  ICMJE April 24, 2014
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy [ Time Frame: 14 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
  • Recurrent UTI Within 28 Days of Completing Active Study Medication [ Time Frame: 28 days ]
    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 ]
    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 This outcome is number of subjects experiencing ANY adverse drug event
  • Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli [ Time Frame: 7 days ]
    Intestinal carriage of antimicrobial-resistant Gram-negative bacilli after completing study medication, as compared to a baseline sample taken early in treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
  • Recurrent UTI Within 28 Days of Completing Active Study Medication [ Time Frame: 28 days ]
    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 ]
    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 ]
    Intestinal carriage of antimicrobial-resistant Gram-negative bacilli after completing study medication, as compared to a baseline sample taken early in treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Seven vs. 14 Days Treatment for Male Urinary Tract Infection
Official Title  ICMJE Seven Versus Fourteen Day Treatment for Male Urinary Tract Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE
  • Other: Longer therapy duration
    14 days of antimicrobial treatment
  • Other: Shorter therapy duration
    7 days of antimicrobial treatment
Study Arms  ICMJE
  • Active Comparator: Longer (14 day) duration antimicrobial treatment
    14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
    Intervention: Other: Longer therapy duration
  • Placebo Comparator: Shorter (7 day) duration antimicrobial treatment
    7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
    Intervention: Other: Shorter therapy duration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
273
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
319
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Study of UTI in men
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994538
Other Study ID Numbers  ICMJE CLIN-008-13S
I01BX007080 ( Other Grant/Funding Number: VA Merit Review )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: No formal plan submitted at time of grant. Will handle such requests on a case-by-case basis with input from local privacy officer and institutional review board.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dimitri M Drekonja, MD Minneapolis VA Health Care System, Minneapolis, MN
PRS Account VA Office of Research and Development
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP