Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
2 other identifiers
interventional
30,000
1 country
19
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Brief Summary
Primary Outcome Measures:Incidence density of colonization with MRSA or VRE (number of new colonization events per 1000 patient days at risk) during the intervention phase. Secondary Outcome Measures:The effect of the 2 strategies on the incidence density of colonization with MRSA and VRE individually will be determined and compared descriptively. The effect of the strategies on the cumulative incidence of bacteremia caused by MRSA and VRE will be determined to assess the clinical relevance of the strategy in preventing infection. The trial will evaluate the frequency of hand hygiene and the use of gloves and gowns by healthcare workers to substantiate whether the effect of the intensive control strategy is mediated, as expected, by an increase in the use of gloves and gowns due to an increase in the number of patients cared for using Contact Precautions.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Reported enrollment (type unavailable)
- 30,000 participants
- Study completion date
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
- Listed locations
- 1 countries · 19 sites
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
December 30, 2004
Actual (reported)First Posted
December 31, 2004
Actual (reported)Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
- Last Updated
- June 10, 2011
- Status Verified
- October 2007
- Last Update Submitted
- June 9, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- ICUs that meet all of the following criteria are eligible to participate in the study:
- Adult medical, surgical, or medical/surgical ICU, meeting the following descriptions:
- Medical ICU-\>=80% of patients have medical conditions and have not undergone a surgical procedure during their hospital stay (patients weaned from mechanical ventilation may be included); Surgical ICU-\>=80% of patients have undergone a surgical procedure during their hospital stay (thoracic, cardiovascular, abdominal, orthopedic, neurosurgical, transplant, urologic, and trauma surgery procedures may be included); and Medical/surgical ICU-a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during their hospitalization (i.e., each group constitutes more than 20% and less than 80% of the total number of patients).
- Patient volume of \>=1200 patient days/6 months or \>=2400 patient days/12 months during 2002, 2003, or 2004;
- Incidence density of colonization of \>=9 colonization events with either MRSA or VRE/1000 ICU patient days based on results of clinical cultures during 2002, 2003, or 2004;
- Ability to collect the data required for the analysis;
- Written approval of the study from the institution's IRB; and
- Signed protocol signature page indicating willingness to enroll ICU in the study from the ICU physician and the ICU nursing directors.
You may not qualify if:
- Intensive care units that meet any of the following criteria are excluded from the study:
- Coronary care, burn, bone marrow/hematopoetic stem cell transplant, neurosurgical, pediatric, or neonatal ICUs;
- ICUs currently screening all patients for colonization with MRSA and VRE on admission to the ICU and at least once a week during their ICU stay with results of surveillance cultures reported to clinicians (Note: ICUs screening only selected, "high-risk" patients, screening patients on admission to the ICU but not an ongoing basis, or screening patients for MRSA or VRE but not both MRSA and VRE are not excluded);
- ICUs currently with a policy for Universal Gloving for all patient contact regardless of whether the patient is known to be colonized with VRE or MRSA;
- ICUs planning to enroll subjects in studies testing investigational agents administered for the purpose of eradicating or preventing colonization with MRSA or VRE or devices or practice management strategies that have colonization and/or infection with resistant organisms as an outcome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5023, United States
Yale University
New Haven, Connecticut, 06510, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
Emory University School of Medicine
Atlanta, Georgia, 30303, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55906, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Beth Israel Medical Center
New York, New York, 10003, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Related Publications (1)
Huskins WC, Huckabee CM, O'Grady NP, Murray P, Kopetskie H, Zimmer L, Walker ME, Sinkowitz-Cochran RL, Jernigan JA, Samore M, Wallace D, Goldmann DA; STAR*ICU Trial Investigators. Intervention to reduce transmission of resistant bacteria in intensive care. N Engl J Med. 2011 Apr 14;364(15):1407-18. doi: 10.1056/NEJMoa1000373.
PMID: 21488763RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 30, 2004
First Posted
December 31, 2004
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
June 10, 2011
Record last verified: 2007-10