Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-Associated Urinary Tract Infections in the Critically Ill - Full Text View

Sponsors and Collaborators:	St. Michael's Hospital, Toronto Kingston General Hospital MOUNT SINAI HOSPITAL Ottawa General Hospital Sunnybrook Health Sciences Centre
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00795470

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infections	Drug: Antimicrobial Device: Catheter change	Phase III

MedlinePlus related topics: Antibiotics Urinary Tract Infections Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment
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

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Number of patients enrolled [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Protocol Ahderence Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ICU free days at Day 30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Microbiologic Outcome [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]
Developement of resistance [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	February 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Appropriate antimicrobial based on urine culture results Device: Catheter change Change urine catheter
Catheter change and NO antimicrobial: Active Comparator	Device: Catheter change Change urine catheter
Antimicrobial and NO catheter change: Active Comparator	Drug: Antimicrobial Appropriate antimicrobial based on urine culture results

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795470

Contacts

Contact: Jan O Friedrich, DPhil, MD, MSc

416-864-6000

Locations

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Kingston General Hospital

MOUNT SINAI HOSPITAL

Ottawa General Hospital

Sunnybrook Health Sciences Centre

Investigators

Principal Investigator:

Jan Friedrich, DPhil, MD, MSc

St. Michael's Hospital, Toronto

More Information

Publications:

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.

Responsible Party:	St. Michael's Hospital ( Dr Jan Friedrich )
Study ID Numbers:	REB 08-287
Study First Received:	November 20, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00795470
Health Authority:	Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:

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

Study placed in the following topic categories:

Urologic Diseases
Critical Illness
Urinary Tract Infections

Additional relevant MeSH terms:

Communicable Diseases
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 14, 2009