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

Primary Purpose

Bacterial Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Control Strategy
Standard Control Strategy
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Diseases focused on measuring Hand hygiene, antibiotic resistance, contact precautions

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • University of Arizona Health Sciences Center
  • Yale University
  • Mayo Clinic - Jacksonville
  • University of Miami
  • Emory University School of Medicine
  • University of Chicago
  • University of Iowa
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • Harper University Hospital
  • Mayo Clinic
  • Cooper University Hospital
  • Beth Israel Medical Center
  • University Hospitals of Cleveland
  • Oregon Health Sciences University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 30, 2004
Last Updated
June 9, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00100386
Brief Title
Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
Official Title
Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Diseases
Keywords
Hand hygiene, antibiotic resistance, contact precautions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Intensive Control Strategy
Intervention Type
Behavioral
Intervention Name(s)
Standard Control Strategy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5023
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55906
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21488763
Citation
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.
Results Reference
result

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

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