Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections.

Urinary Tract Infections Clinical Trial

— CAUTION  

Official title:

A Pilot Concealed Randomized Double-blinded Placebo-controlled Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00795470
• Other study ID #: REB 08-287
• Status: Withdrawn
• Phase: Phase 3
• First received: November 20, 2008
• Last updated: December 1, 2015
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria.

The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed.

Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult ICU patient (= 18 years old)

2. Admitted to the ICU for = 96 hours

3. Indwelling urinary catheter in place for = 48hours that was inserted during this hospital admission

4. Urine culture positive (= 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)

5. Have received antimicrobial therapy that would cover the isolated organism(s) in the index urine culture for < 24 hours (i.e. therapy that does NOT cover the isolated organism(s) in the index urine culture of any duration or antimicrobial that covers the index urine organism for < 24 hours are permitted)

Exclusion Criteria:

1. Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture

2. Anuria (< 50 mL/day)

3. Imminent death within 48 hours or decision to withdraw supportive care by clinical team

4. Neutropenia (< 500/mm3)

5. Patient has an alternative infection and requires an antimicrobial that has a spectrum of activity which include all the organism(s) isolated from the index urine culture

6. Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Antimicrobial
Appropriate antimicrobial based on urine culture results

Device:
• Catheter change
Change urine catheter

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Kingston General Hospital, Mount Sinai Hospital, New York, Sunnybrook Health Sciences Centre, The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Chant C, Dos Santos CC, Saccucci P, Smith OM, Marshall JC, Friedrich JO. Discordance between perception and treatment practices associated with intensive care unit-acquired bacteriuria and funguria: a Canadian physician survey. Crit Care Med. 2008 Apr;36(4):1158-67. doi: 10.1097/CCM.0b013e3181692af9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients enrolled	none enrolled	18 months	No
Primary	Protocol Adherence Rate		18 months	No
Secondary	ICU free days at Day 30		30 days	No
Secondary	Microbiologic Outcome		Day 7 and 14	No
Secondary	Developement of resistance		14 days	Yes