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

NCT00795470 | Withdrawn Phase 3 DMC

• 1 other identifier: REB 08-287
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Tract Infections

Keywords

urinary tract infection; critically ill; ICU; antimicrobial; Catheter associated urinary tract infections

Outcome Measures

Primary Outcomes (2)

• Number of patients enrolled

  none enrolled

  18 months

• Protocol Adherence Rate

  18 months

Secondary Outcomes (3)

• ICU free days at Day 30

  30 days

• Microbiologic Outcome

  Day 7 and 14

• Developement of resistance

  14 days

Study Arms (4)

No catheter change no antimicrobial

NO INTERVENTION

Urinary catheter will not be changed and no antimicrobials will be prescribed

Antimicrobial and catheter change

ACTIVE COMPARATOR

Drug: Antimicrobial; Device: Catheter change

Catheter change and NO antimicrobial

ACTIVE COMPARATOR

Device: Catheter change

Antimicrobial and NO catheter change

ACTIVE COMPARATOR

Drug: Antimicrobial

Interventions

Antimicrobial DRUG

Appropriate antimicrobial based on urine culture results

Antimicrobial and NO catheter change; Antimicrobial and catheter change

Catheter change DEVICE

Change urine catheter

Antimicrobial and catheter change; Catheter change and NO antimicrobial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ICU patient (≥ 18 years old)
• Admitted to the ICU for ≥ 96 hours
• Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
• Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
• 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)

You may not qualify if:

• Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
• Anuria (\< 50 mL/day)
• Imminent death within 48 hours or decision to withdraw supportive care by clinical team
• Neutropenia (\< 500/mm3)
• 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
• Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)

Sponsors & Collaborators

• Unity Health Toronto: lead
• Kingston Health Sciences Centre: collaborator
• Mount Sinai Hospital, New York: collaborator
• The Ottawa Hospital: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related 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.

  PMID: 18379242 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Critical Illness

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jan Friedrich, DPhil, MD, MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-11

Locations

CA (1)