Status:
COMPLETED
Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Catheter-Associated Urinary Tract Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention ...
Detailed Description
Urinary tract infections (UTI) are the most common hospital-acquired infections, accounting for nearly 30% of cases of nosocomial infections and affecting nearly 1 million people per year. Following ...
Eligibility Criteria
Inclusion
- Age greater than 18
- Creatinine clearance greater than 30 ml/min
- Failed postoperative hospital voiding trial
Exclusion
- Pregnant
- History of glucose-6-phosphate dehydrogenase deficiency
- History of renal insufficiency, renal transplant, or nephropathy
- Allergy to nitrofurantoin
- History of recurrent UTI (defined as greater than two culture-proven infections in six months or three infections in one year)
- Urinary Tract Infection (UTI) within 14 days one month of surgery
- Non-English speaking
- Urinary tract infection while Foley catheter is in place
- On antibiotic therapy for other non-urological reasons
- Sustained intraoperative bladder injury requiring prolonged catheterization greater than 5 days
- Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair, urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other procedure requiring prolonged catheterization and bladder decompression
- Placement of a suprapubic catheter
- Participants that request intermittent self-catheterization
- Neurologic conditions affecting urinary tract system and normal voiding mechanisms
- History of hepatic impairment due to prior nitrofurantoin use
- Inability to provide consent/decisionally impaired
- More than two in-office voiding trials
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT03287089
Start Date
September 29 2017
End Date
June 1 2019
Last Update
August 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atrium Health
Charlotte, North Carolina, United States, 28207