Trial Outcomes & Findings for Seven vs. 14 Days Treatment for Male Urinary Tract Infection (NCT NCT01994538)
NCT ID: NCT01994538
Last Updated: 2021-06-02
Results Overview
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.
COMPLETED
NA
273 participants
14 days
2021-06-02
Participant Flow
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.
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.
Participant milestones
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
136
|
|
Overall Study
COMPLETED
|
136
|
136
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seven vs. 14 Days Treatment for Male Urinary Tract Infection
Baseline characteristics by cohort
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
n=136 Participants
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
n=136 Participants
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
136 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Indwelling catheter use
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Intermittent catheter use
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Diabetes
|
60 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
CKD
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Cerebrovascular accident
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Spinal cord injury
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
HIV
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Prostatic hypertrophy
|
47 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Prostatitis
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Prostate Cancer
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Prior UTI
|
78 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Incontinence
|
52 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Urethral stricture
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: 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)
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.
Outcome measures
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
n=123 Participants
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
n=131 Participants
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
|---|---|---|
|
Resolution of UTI Symptoms 14 Days After Completing Active Antimicrobial Therapy
|
111 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: 28 daysNew onset of symptomatic UTI within the 28 day follow-up period
Outcome measures
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
n=123 Participants
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
n=131 Participants
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
|---|---|---|
|
Recurrent UTI Within 28 Days of Completing Active Study Medication
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 28 daysThe 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
Outcome measures
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
n=136 Participants
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
n=136 Participants
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
|---|---|---|
|
Adverse Drug Event in the 28 Days After Completing Study Medication
|
29 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: of the 163 subjects who participated in the optional intestinal carriage sub-study, 65 had growth in both of the submitted stool samples and are included in this analysis
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.
Outcome measures
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
n=29 Participants
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
n=36 Participants
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
|---|---|---|
|
Intestinal Carriage of Antimicrobial-resistant Gram Negative Bacilli
|
4 Participants
|
4 Participants
|
Adverse Events
Longer (14 Day) Duration Antimicrobial Treatment
Shorter (7 Day) Duration Antimicrobial Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Longer (14 Day) Duration Antimicrobial Treatment
n=136 participants at risk
14 days of ciprofloxacin or trimethoprim/sulfamethoxazole
Longer therapy duration: 14 days of antimicrobial treatment
|
Shorter (7 Day) Duration Antimicrobial Treatment
n=136 participants at risk
7 days of ciprofloxacin or trimethoprim/sulfamethoxazole, followed by 7 days of placebo
Shorter therapy duration: 7 days of antimicrobial treatment
|
|---|---|---|
|
General disorders
Any adverse event
|
24.3%
33/136 • Number of events 51 • 28 days
|
20.6%
28/136 • Number of events 40 • 28 days
|
Additional Information
Dimitri Drekonja, MD, MS
Minneapolis VA Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place