Catheter-Associated Urinary Tract Infection
Conditions
Keywords
catheter, urinary tract infection
Brief summary
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.
Interventions
DRUGBactrim
Bactrim DS BID for 3 days
OTHERPlacebo
Corn starch capsules
Sponsors
American Urogynecologic Society
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Requires catheterization \>24h hours following incontinence or pelvic reconstructive surgery
Exclusion criteria
* Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization * Allergy to sulfonamides or trimethoprim * Non-English speaking * Pregnancy * Breast feeding * Severe renal impairment (creatinine clearance \<30) * Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urinary Tract Infection | 7 days following catheter removal | Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \>100,000 colony forming units/mL |
Countries
United States
Participant flow
Recruitment details
A total of 52 subjects were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Drug Bactrim: Bactrim DS BID for 3 days
Demographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment. | 26 |
| Placebo Placebo: Corn starch capsules | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Drug | Placebo | Total |
|---|---|---|---|
| Age, Customized Mean Age | 60 years STANDARD_DEVIATION 12.9 | 58 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 12.9 |
| Body mass index | 25.8 kg/m^2 STANDARD_DEVIATION 2.7 | 27.2 kg/m^2 STANDARD_DEVIATION 4.3 | 26.5 kg/m^2 STANDARD_DEVIATION 3.5 |
| Region of Enrollment United States | 26 participants | 26 participants | 52 participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Number of Participants With Urinary Tract Infection
Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \>100,000 colony forming units/mL
Time frame: 7 days following catheter removal
Population: Study terminated early.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug | Number of Participants With Urinary Tract Infection | 6 Participants |
| Placebo | Number of Participants With Urinary Tract Infection | 6 Participants |