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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00100386
Recruitment Status : Completed
First Posted : December 31, 2004
Last Update Posted : June 10, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Bacterial Diseases Procedure: Intensive Control Strategy Behavioral: Standard Control Strategy

Detailed Description:
This study will determine if rates of colonization and infection with 2 resistant Gram positive bacteria-methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE) among patients in adult intensive care units (ICUs) are lower in ICUs that use an intensive infection control strategy plus standard care compared to ICUs that use standard care alone. The intensive control strategy involves: 1) identifying patients who are colonized with MRSA or VRE by reporting the results of surveillance cultures of the anterior nares and stool or perianal area; 2) Universal Gloving (use of gloves during interactions with the patient or the patient's environment) until the patients are discharged or their surveillance culture results show they are not colonized with MRSA or VRE (whichever happens first); and 3) Contact Precautions (use of gloves and gowns during interactions with the patient or the patient's environment) during care of patients who are colonized with MRSA or VRE. Standard care involves proper hand hygiene (handwashing or use of a waterless hand antiseptic) and use of Standard Precautions (use of gloves and other barriers as needed for interactions involving contact with mucous membranes, wounds, and body fluids) and collection of surveillance cultures, but not reporting of results to these sites. The surveillance cultures will be performed by obtaining swabs of the nose and stool or perianal area from patients upon admission to the ICU, at weekly intervals thereafter, and upon discharge from the ICU. The results of the surveillance cultures will be used to compare the rate of colonization with MRSA and VRE in ICUs using the intensive control strategy with those that use standard care alone.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
Study Start Date : March 2005
Estimated Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

ICUs that meet all of the following criteria are eligible to participate in the study:

  1. 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).

  2. Patient volume of >=1200 patient days/6 months or >=2400 patient days/12 months during 2002, 2003, or 2004;
  3. 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;
  4. Ability to collect the data required for the analysis;
  5. Written approval of the study from the institution's IRB; and
  6. Signed protocol signature page indicating willingness to enroll ICU in the study from the ICU physician and the ICU nursing directors.

Exclusion Criteria:

Intensive care units that meet any of the following criteria are excluded from the study:

  1. Coronary care, burn, bone marrow/hematopoetic stem cell transplant, neurosurgical, pediatric, or neonatal ICUs;
  2. 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);
  3. 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;
  4. 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100386

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5023
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Harper University Hospital
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55906
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Responsible Party: Director ORA, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00100386     History of Changes
Obsolete Identifiers: NCT00342745
Other Study ID Numbers: 02-081
BAMSG 4-01
First Posted: December 31, 2004    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: October 2007

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Hand hygiene, antibiotic resistance, contact precautions

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents