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CLUSTER Trial for Outbreak Detection and Response (CLUSTER)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053075
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Hospital Corporation of America (HCA) Healthcare
Brigham and Women's Hospital
University of California, Irvine
Harvard School of Public Health
Rush University
Duke University
University of Massachusetts, Amherst
University of California, San Francisco
Cook County Health & Hospitals System
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

Brief Summary:

Despite the critical importance of identifying hospital-associated outbreaks as early as possible in order to limit their spread, there are currently no standardized methods for cluster detection. The CLUSTER Trial (Cluster Linkage Using Statistics to Trigger and Evaluate Response) will assess whether a statistically-based automated cluster detection method coupled with a robust response protocol will enable rapid containment of hospital clusters as measured by a reduction in cluster size and duration as compared to routine hospital cluster detection methods coupled with the same response protocol.

Note: that enrolled "subjects" represents 82 individual HCA Healthcare hospitals that have been randomized


Condition or disease Intervention/treatment Phase
Cluster Detection Other: Routine cluster detection Other: Enhanced cluster detection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : December 23, 2023
Estimated Study Completion Date : December 23, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Routine cluster detection
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Other: Routine cluster detection
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.

Active Comparator: Enhanced cluster detection
Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Other: Enhanced cluster detection
Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.




Primary Outcome Measures :
  1. Cluster size [ Time Frame: 30 months ]

    Cluster size defined as number of cases identified after the initial cluster signal through the last cluster case.

    NOTE: this outcome is intended for the primary manuscript.



Secondary Outcome Measures :
  1. Cluster duration [ Time Frame: 30 months ]

    Cluster duration defined as number of days from the initial cluster signal through the last cluster case.

    NOTE: this outcome is intended for the primary manuscript.



Other Outcome Measures:
  1. Genetic relatedness of clusters of microbial isolates [ Time Frame: 30 months ]

    Compare the genetic relatedness of isolates within a cluster, defined by the automated cluster detection tool or routine cluster detection methods.

    NOTE: this exploratory analysis is intended for a secondary manuscript.


  2. Pathogen subgroup analysis [ Time Frame: 30 months ]

    Subset analyses of trial outcomes (e.g., Gram-positive clusters, Gram-negative clusters, fungal clusters, Clostridium difficile & multidrug-resistant organism clusters).

    NOTE: this exploratory analysis is intended for a secondary manuscript.




Information from the National Library of Medicine

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

Facility Inclusion Criteria:

  • All U.S. HCA Healthcare hospitals that provide inpatient care.
  • Facilities that are reporting to the centralized data warehouse during the study period.

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital.


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): NCT04053075


Contacts
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Contact: Micaela Coady, MS 617-867-4880 micaela_coady@hphc.org
Contact: Meghan Baker, MD, ScD 617-732-8881 mbaker1@bwh.harvard.edu

Locations
Show Show 82 study locations
Sponsors and Collaborators
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA) Healthcare
Brigham and Women's Hospital
University of California, Irvine
Harvard School of Public Health
Rush University
Duke University
University of Massachusetts, Amherst
University of California, San Francisco
Cook County Health & Hospitals System
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Richard Platt, MD, MS Harvard Pilgrim Health Care Institute
Principal Investigator: Susan Huang, MD, MPH University of California, Irvine
Study Director: Meghan Baker, MD, ScD Brigham and Women's Hospital
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Responsible Party: Richard Platt, Professor and Department Chair, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT04053075    
Other Study ID Numbers: PH000599B
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Platt, Harvard Pilgrim Health Care:
Hospital Outbreak Detection
Hospital Outbreak Response
Cluster
Multidrug Resistant Organism
Genetic Relatedness
Whole Genome Sequencing