NCT03101371

Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

Completed Phase 2 Results posted Last updated 10 March 2020

What this trial tests

Phase 2 trial testing Catheter insertion with Povidone Iodine in Urinary Tract Infections in 99 participants. Completed in 15 February 2019.

Timeline

10 October 2017

Primary endpoint
15 February 2019

15 February 2019

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	99
Start date	10 October 2017
Primary completion	15 February 2019
Estimated completion	15 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Catheter insertion with Povidone Iodine — full drug profile →
• Standard of care catheter insertion

Conditions studied

• Urinary Tract Infections — all drugs for Urinary Tract Infections →
• Catheter Infection — all drugs for Catheter Infection →
• Catheter-Related Infections — all drugs for Catheter-Related Infections →

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 89, female only, with Urinary Tract Infections or Catheter Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) Primary · Within 14 +/- 2 days post-surgery

Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as \>10\^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	7
Aseptic Protocol for Catheter Insertion	6

Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation Secondary · Day 14 (+/- 2 days)

Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	38
Aseptic Protocol for Catheter Insertion	40
Standard of Care Protocol Catheter Insertion	7
Aseptic Protocol for Catheter Insertion	5

Average Patient Satisfaction Secondary · Day14 (+/- 2 days)

Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	8.17	± 2.39
Aseptic Protocol for Catheter Insertion	8.6	± 2.04

Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI) Secondary · 14 days (+/- 2 days) from surgery

Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	0
Aseptic Protocol for Catheter Insertion	1

Number of Participants With Closed Drainage System Disrupted During Placement of Catheter Secondary · Day 1 post op

Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	42
Aseptic Protocol for Catheter Insertion	42

Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason Secondary · Day 14 (+/- 2 days)

Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	0
Aseptic Protocol for Catheter Insertion	1

Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery Secondary · Day 14 (+/- 2 days)

Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.

Cefazolin (1st gen cephalosporin))

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	36
Aseptic Protocol for Catheter Insertion	39

Cefoxitin Cefuroxime / Cefotetan (2nd gen cephalo

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	5
Aseptic Protocol for Catheter Insertion	0

Metronidazole

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	12
Aseptic Protocol for Catheter Insertion	11

Clindamycin

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	5
Aseptic Protocol for Catheter Insertion	6

Doxycycline

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	0
Aseptic Protocol for Catheter Insertion	0

Gentamicin

Group	Value	95% CI
Standard of Care Protocol Catheter Insertion	3
Aseptic Protocol for Catheter Insertion	6

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 days +/- 2 days post-surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care Protocol Catheter Insertion

Serious: 0/45 (0%)

Deaths: 0/45

Aseptic Protocol for Catheter Insertion

Serious: 0/45 (0%)

Deaths: 0/45

Other adverse events (4 terms — click to expand)

Reaction	System	Standard of Care Protocol …	Aseptic Protocol for Cathe…
Catheter discomfort	Surgical and medical procedures	—	—
Neutropenic fever	Blood and lymphatic system disorders	—	—
Hematuria	Renal and urinary disorders	—	—
Constipation	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03101371 adverse events section.

Sponsor's own description

Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.