Trial Outcomes & Findings for Multifaceted Treatment of Catheter-related Urinary Tract Infection (NCT NCT00732238)
NCT ID: NCT00732238
Last Updated: 2015-02-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
New Catheter Arm
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Existing Catheter Arm
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
New Catheter Arm
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Existing Catheter Arm
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
|---|---|---|
|
Overall Study
Bacteremia
|
4
|
1
|
|
Overall Study
Asymptomatic bacteriuria
|
1
|
0
|
Baseline Characteristics
Multifaceted Treatment of Catheter-related Urinary Tract Infection
Baseline characteristics by cohort
| Measure |
New Catheter Arm
n=28 Participants
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Existing Catheter Arm
n=27 Participants
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 13 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)Outcome measures
| Measure |
Arm 1
n=28 Participants
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Arm 2
n=27 Participants
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
|---|---|---|
|
The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect
|
28 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Up to 180 days of end of therapyRelapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (\>10 WBC/phf)
Outcome measures
| Measure |
Arm 1
n=28 Participants
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Arm 2
n=27 Participants
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
|---|---|---|
|
The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy
|
9 participants
|
3 participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=28 participants at risk
Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.
Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Arm 2
n=27 participants at risk
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.
Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
|---|---|---|
|
Gastrointestinal disorders
C diff colitis
|
7.1%
2/28 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
Additional Information
Rabih Darouiche
Michael E DeBakey VA Medical Center-Baylor College of Medicine
Phone: 713-841-3882
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place