NCT04053075|CompletedResults
CLUSTER Trial for Outbreak Detection and Response
CLUSTER
Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response
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Sponsor study identifier
interventional
2,905,455
1 country
82
Study Start
July 23, 2019
Actual (reported)Primary Completion
May 20, 2024
Actual (reported)Study Completion
May 20, 2024
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 23, 2019
Actual (reported)August 8, 2019
Actual (reported)August 12, 2019
Actual (reported)May 20, 2024
Actual (reported)May 20, 2024
Actual (reported)January 16, 2025
Actual (reported)Cluster Size
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.
30 months
Cluster Duration
30 months
Genetic Relatedness of Clusters of Microbial Isolates
30 months
Pathogen Subgroup Analysis
30 months
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
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.
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
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.
Riverside Community Hospital
Riverside, California, 92501, United States
Regional Medical Center of San Jose
San Jose, California, 95116, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
Swedish Medical Center
Denver, Colorado, 80113, United States
Sky Ridge Medical Center
Denver, Colorado, 80124, United States
Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Baker MA, Septimus E, Kleinman K, Moody J, Sands KE, Varma N, Isaacs A, McLean LE, Coady MH, Blanchard EJ, Poland RE, Yokoe DS, Stelling J, Haffenreffer K, Clark A, Avery TR, Sljivo S, Weinstein RA, Smith KN, Carver B, Meador B, Lin MY, Lewis SS, Washington C, Bhattarai M, Shimelman L, Kulldorff M, Reddy SC, Jernigan JA, Perlin JB, Platt R, Huang SS. A Trial of Automated Outbreak Detection to Reduce Hospital Pathogen Spread. NEJM Evid. 2024 May;3(5):EVIDoa2300342. doi: 10.1056/EVIDoa2300342. Epub 2024 Apr 23.
\[Not Specified\]
Richard Platt, MD, MSc
Harvard Pilgrim Health Care Institute
Susan Huang, MD, MPH
University of California, Irvine
Meghan Baker, MD, ScD
Brigham and Women's Hospital
2,905,455 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2019
First Posted
August 12, 2019
Study Start
July 23, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
North Suburban Medical Center - JV
Thornton, Colorado, 80229, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Brandon Regional
Brandon, Florida, 33511, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216, United States
Lake City Medical Center
Lake City, Florida, 32055, United States
Largo Medical Center
Largo, Florida, 33770, United States
Ocala Regional Medical Center
Ocala, Florida, 34471, United States
West Marion Community Hospital
Ocala, Florida, 34474, United States
Raulerson Hospital
Okeechobee, Florida, 34972, United States
Orange Park Medical Center
Orange Park, Florida, 32073, United States
Gulf Coast Medical Center
Panama City, Florida, 32405, United States
West Florida Hospital
Pensacola, Florida, 32514, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952, United States
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952, United States
Central Florida Regional Hospital
Sanford, Florida, 32771, United States
Doctor's Hospital Sarasota
Sarasota, Florida, 34233, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
South Bay Hospital
Sun City Center, Florida, 33573, United States
Medical Center of Trinity
Trinity, Florida, 34655, United States
JFK Medical Center - North Campus
West Palm Beach, Florida, 33407, United States
Fairview Park
Dublin, Georgia, 31021, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
Eastside Medical Center
Snellville, Georgia, 30078, United States
West Valley Medical Center
Caldwell, Idaho, 83605, United States
Eastern Idaho Regional
Idaho Falls, Idaho, 83404, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Wesley Woodlawn Hospital
Wichita, Kansas, 67220, United States
Greenview Regional Hospital
Bowling Green, Kentucky, 42104, United States
Garden Park Medical Center
Gulfport, Mississippi, 39503, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063, United States
Mountainview Hospital - Vegas
Las Vegas, Nevada, 89128, United States
Parkland Medical Center
Derry, New Hampshire, 03038, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Spotsylvania Regional Medical Center
Fredericksburg, Pennsylvania, 22408, United States
Trident Regional Medical Center
Charleston, South Carolina, 29406, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572, United States
Summerville Medical Center
Summerville, South Carolina, 29485, United States
Colleton Medical Center
Walterboro, South Carolina, 29488, United States
TriStar Horizon Medical Center
Dickson, Tennessee, 37055, United States
Summit Medical Center
Hermitage, Tennessee, 37076, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Southern Hills Medical Center
Nashville, Tennessee, 37211, United States
Medical City Arlington
Arlington, Texas, 76015, United States
St. David's Medical Center
Austin, Texas, 78705, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Valley Regional Medical Center
Brownsville, Texas, 78526, United States
Conroe Regional Medical Center
Conroe, Texas, 77304, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Medical City Denton
Denton, Texas, 76210, United States
Las Palmas Medical Center
El Paso, Texas, 79902, United States
Medical City Fort Worth
Fort Worth, Texas, 76104, United States
Medical City Alliance
Fort Worth, Texas, 76177, United States
St. David's Georgetown Hospital
Georgetown, Texas, 78626, United States
Kingwood Medical Center
Kingwood, Texas, 77339, United States
Medical Center of Lewisville
Lewisville, Texas, 75057, United States
Rio Grande Regional Hospital
McAllen, Texas, 78503, United States
Medical City McKinney
McKinney, Texas, 75069, United States
Medical City North Hills
North Richland Hills, Texas, 76180, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Methodist Stone Oak Hospital
San Antonio, Texas, 78229, United States
Northeast Methodist Hospital
San Antonio, Texas, 78229, United States
Mainland Medical Center
Texas City, Texas, 77591, United States
Clearlake Regional Medical Center
Webster, Texas, 77598, United States
Ogden Regional Medical Center
Ogden, Utah, 84405, United States
LewisGale Hospital - Montgomery
Blacksburg, Virginia, 24060, United States
Reston Hospital
Reston, Virginia, 20190, United States
Retreat Doctors' Hospital
Richmond, Virginia, 23220, United States
CJW Medical Center (Chippenham Campus)
Richmond, Virginia, 23225, United States
CJW Medical Center (Johnston Willis Campus)
Richmond, Virginia, 23225, United States
Henrico Doctors' Hospital - Forest Campus
Richmond, Virginia, 23229, United States
Henrico Doctors' Hospital - Parham Campus
Richmond, Virginia, 23294, United States
Primary Completion
May 20, 2024
Actual (reported)Study Completion
May 20, 2024
Actual (reported)Last Updated
January 16, 2025
Results First Posted
January 16, 2025
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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