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Seven vs. 14 Days Treatment for Male Urinary Tract Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01994538
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 28, 2020
Last Update Posted : June 2, 2021
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Other: Longer therapy duration Other: Shorter therapy duration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Seven Versus Fourteen Day Treatment for Male Urinary Tract Infection
Actual Study Start Date : April 24, 2014
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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. Antimicrobial resistance for this measure was defined as newly detected resistance to either of the study drugs, ciprofloxacin or trimethoprim/sulfamethoxazole.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study of UTI in men
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01994538

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United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Dimitri M Drekonja, MD Minneapolis VA Health Care System, Minneapolis, MN
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development Identifier: NCT01994538    
Other Study ID Numbers: CLIN-008-13S
I01BX007080 ( Other Grant/Funding Number: VA Merit Review )
First Posted: November 25, 2013    Key Record Dates
Results First Posted: October 28, 2020
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
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
Informed Consent Form (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.

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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
Keywords provided by VA Office of Research and Development:
Urinary Tract Infections
Urinary antiinfective agents
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents