Bacterial DiseasesNCT00100386
Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
A study of Bacterial Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Diseases
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 30,000 participants
- Where
- 19 sitesUnited States
- Study dates
- Mar 2005to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30303
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper University Hospital
Camden, New Jersey, 08103
University of Chicago
Chicago, Illinois, 60637
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Harper University Hospital
Detroit, Michigan, 48201
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06510
Beth Israel Medical Center
New York, New York, 10003
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55906
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5023
About this study
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.
Read the 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.
- Conditions
- Bacterial Diseases
- Being tested
- Intensive Control Strategy, Standard Control Strategy
- Keywords
- Hand hygiene, antibiotic resistance, contact precautions
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Control StrategyProcedure or surgery
Standard Control StrategyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2004 (estimated)
- Study startMar 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100386
- Sponsor's protocol ID
- 02-081
- Other IDs
- BAMSG 4-01
- Status last verified
- Oct 2007
- First submitted
- 30 Dec 2004
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
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.
PubMed 21488763
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
- ClinicalTrials.gov ID
- NCT00100386
- Acronym / sponsor ID
- 02-081
- Conditions
- Bacterial Diseases
- Keywords
- Hand hygiene, antibiotic resistance, contact precautions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2005
- Study completion
- Aug 2006
- First posted
- 31 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Control Strategy | Procedure or surgery | – |
| Standard Control Strategy | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Results publication: PubMed 21488763Huskins 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.
Related trials for Bacterial Diseases
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bacterial Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.