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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Urinary Tract Infections
Interventions Other: Longer therapy duration
Other: Shorter therapy duration
Enrollment 273
Recruitment Details Enrolled subjects are afebrile men with symptomatic urinary tract infection who were initially treated with 7-14 days of trimethoprim/sulfamethoxazole (TMP/SMZ) or ciprofloxacin by the treating clinician. Subjects were randomized prior to day 8 of treatment to an additional 7 days of their original study drug (14d group) or placebo (7d group.
Pre-assignment Details

Primary analysis was per-protocol, and included all subjects who took at least 26 of 28 doses of medication.

Intention to treat analysis includes all randomized subjects.

Arm/Group Title Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Hide Arm/Group Description

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Longer therapy duration: 14 days of antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Shorter therapy duration: 7 days of antimicrobial treatment

Period Title: Overall Study
Started [1] 136 136
Completed [2] 136 136
Not Completed 0 0
[1]
One subject consented but was not randomized due to a miscommunication with the research pharmacy
[2]
A second site (Houston VA) was added mid-study, and began enrolling 1/2018
Arm/Group Title Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment Total
Hide Arm/Group Description

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Longer therapy duration: 14 days of antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Shorter therapy duration: 7 days of antimicrobial treatment

Total of all reporting groups
Overall Number of Baseline Participants 136 136 272
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 136 participants 272 participants
67.8  (11.6) 67.8  (11.6) 67.8  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
136
 100.0%
136
 100.0%
272
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
Hispanic or Latino
8
   5.9%
5
   3.7%
13
   4.8%
Not Hispanic or Latino
126
  92.6%
127
  93.4%
253
  93.0%
Unknown or Not Reported
2
   1.5%
4
   2.9%
6
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
American Indian or Alaska Native
5
   3.7%
1
   0.7%
6
   2.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
23
  16.9%
26
  19.1%
49
  18.0%
White
105
  77.2%
107
  78.7%
212
  77.9%
More than one race
2
   1.5%
1
   0.7%
3
   1.1%
Unknown or Not Reported
1
   0.7%
1
   0.7%
2
   0.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 136 participants 136 participants 272 participants
136
 100.0%
136
 100.0%
272
 100.0%
Indwelling catheter use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
8
   5.9%
8
   5.9%
16
   5.9%
Intermittent catheter use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
23
  16.9%
24
  17.6%
47
  17.3%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
60
  44.1%
46
  33.8%
106
  39.0%
CKD  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
14
  10.3%
8
   5.9%
22
   8.1%
Cerebrovascular accident  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
5
   3.7%
13
   9.6%
18
   6.6%
Spinal cord injury  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
6
   4.4%
5
   3.7%
11
   4.0%
HIV  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
2
   1.5%
2
   1.5%
4
   1.5%
Prostatic hypertrophy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
47
  34.6%
56
  41.2%
103
  37.9%
Prostatitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
18
  13.2%
16
  11.8%
34
  12.5%
Prostate Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
23
  16.9%
21
  15.4%
44
  16.2%
Prior UTI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
78
  57.4%
84
  61.8%
162
  59.6%
Incontinence  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
52
  38.2%
44
  32.4%
96
  35.3%
Urethral stricture  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 136 participants 272 participants
16
  11.8%
17
  12.5%
33
  12.1%
1.Primary Outcome
Title Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis (including all subjects who took medication as directed, defined as at least 26 of 28 doses, missing no more than 2 consecutive doses)
Arm/Group Title Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Hide Arm/Group Description:

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Longer therapy duration: 14 days of antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Shorter therapy duration: 7 days of antimicrobial treatment

Overall Number of Participants Analyzed 123 131
Measure Type: Count of Participants
Unit of Measure: Participants
111
  90.2%
122
  93.1%
2.Secondary Outcome
Title Recurrent UTI Within 28 Days of Completing Active Study Medication
Hide Description New onset of symptomatic UTI within the 28 day follow-up period
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Hide Arm/Group Description:

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Longer therapy duration: 14 days of antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Shorter therapy duration: 7 days of antimicrobial treatment

Overall Number of Participants Analyzed 123 131
Measure Type: Count of Participants
Unit of Measure: Participants
15
  12.2%
13
   9.9%
3.Secondary Outcome
Title Adverse Drug Event in the 28 Days After Completing Study Medication
Hide Description

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

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Hide Arm/Group Description:

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Longer therapy duration: 14 days of antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Shorter therapy duration: 7 days of antimicrobial treatment

Overall Number of Participants Analyzed 136 136
Measure Type: Count of Participants
Unit of Measure: Participants
29
  21.3%
26
  19.1%
4.Secondary Outcome
Title Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli
Hide Description Intestinal carriage of antimicrobial-resistant Gram-negative bacilli after completing study medication, as compared to a baseline sample taken early in treatment.
Time Frame 7 days
Outcome Measure Data Not Reported
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Hide Arm/Group Description

14 days of ciprofloxacin or trimethoprim/sulfamethoxazole

Longer therapy duration: 14 days of antimicrobial treatment

7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo

Shorter therapy duration: 7 days of antimicrobial treatment

All-Cause Mortality
Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/136 (0.00%)      0/136 (0.00%)    
Hide Serious Adverse Events
Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/136 (0.00%)      0/136 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Longer (14 Day) Duration Antimicrobial Treatment Shorter (7 Day) Duration Antimicrobial Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/136 (24.26%)      28/136 (20.59%)    
General disorders     
Any adverse event  [1]  33/136 (24.26%)  51 28/136 (20.59%)  40
Indicates events were collected by systematic assessment
[1]
Adverse events assessed were: C difficile, nausea, vomiting, diarrhea, dizziness, headache, allergic reaction, thrush, muscle/joint aches, abnormal blood sugars, and changes in warfarin dosing. Subjects may have more than one adverse event.
Goal enrollment was 290; actual enrollment of 273 slightly reduces power to detect minimally clinically significant difference.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dimitri Drekonja, MD, MS
Organization: Minneapolis VA Health Care System
Phone: 612 467 4183
EMail: dimitri.drekonja@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01994538    
Other Study ID Numbers: CLIN-008-13S
I01BX007080 ( Other Grant/Funding Number: VA Merit Review )
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: October 2, 2020
Results First Posted: October 28, 2020
Last Update Posted: October 28, 2020