Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial

Completed · Not applicable

Conditions studied: Bacterial Diseases

In brief

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.

Key facts

Study ID

NCT00100386

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30000

Starts

2005-03-01

Expected to finish

2006-08-01

Last updated by the study team

2011-06-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Harper University Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Beth Israel Medical Center — New York, New York, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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