Cluster DetectionCLUSTERNCT04053075

CLUSTER Trial for Outbreak Detection and Response

A study testing Routine cluster detection and Enhanced cluster detection in people with Cluster Detection, run by Harvard Pilgrim Health Care at 82 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Cluster Detection
What is being tested?: Routine cluster detection and Enhanced cluster detection
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,905,455 participants
Where: 82 sitesUnited States
Study dates: 23 Jul 2019to 20 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Trial locations and contacts

82 sites in 1 country.

City, postcode or hospital

82 sites in 1 country

United States82 sites

Medical City Arlington
Arlington, Texas, 76015
JFK Medical Center
Atlantis, Florida, 33462
St. David's Medical Center
Austin, Texas, 78705
Heart Hospital of Austin
Austin, Texas, 78756
LewisGale Hospital - Montgomery
Blacksburg, Virginia, 24060
Greenview Regional Hospital
Bowling Green, Kentucky, 42104
Brandon Regional
Brandon, Florida, 33511
Valley Regional Medical Center
Brownsville, Texas, 78526
West Valley Medical Center
Caldwell, Idaho, 83605
Trident Regional Medical Center
Charleston, South Carolina, 29406
Conroe Regional Medical Center
Conroe, Texas, 77304
Medical City Dallas Hospital
Dallas, Texas, 75230
Medical City Denton
Denton, Texas, 76210
Swedish Medical Center
Denver, Colorado, 80113
Sky Ridge Medical Center
Denver, Colorado, 80124
Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
Parkland Medical Center
Derry, New Hampshire, 03038
TriStar Horizon Medical Center
Dickson, Tennessee, 37055
Fairview Park
Dublin, Georgia, 31021
Las Palmas Medical Center
El Paso, Texas, 79902
Medical City Fort Worth
Fort Worth, Texas, 76104
Medical City Alliance
Fort Worth, Texas, 76177
Spotsylvania Regional Medical Center
Fredericksburg, Pennsylvania, 22408
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950
St. David's Georgetown Hospital
Georgetown, Texas, 78626
Garden Park Medical Center
Gulfport, Mississippi, 39503
Summit Medical Center
Hermitage, Tennessee, 37076
Eastern Idaho Regional
Idaho Falls, Idaho, 83404
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216
Research Medical Center
Kansas City, Missouri, 64132
Kingwood Medical Center
Kingwood, Texas, 77339
Lake City Medical Center
Lake City, Florida, 32055
Largo Medical Center
Largo, Florida, 33770
Mountainview Hospital - Vegas
Las Vegas, Nevada, 89128
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063
Medical Center of Lewisville
Lewisville, Texas, 75057
Rio Grande Regional Hospital
McAllen, Texas, 78503
Medical City McKinney
McKinney, Texas, 75069
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572
Centennial Medical Center
Nashville, Tennessee, 37203
Southern Hills Medical Center
Nashville, Tennessee, 37211
Medical City North Hills
North Richland Hills, Texas, 76180
Ocala Regional Medical Center
Ocala, Florida, 34471
West Marion Community Hospital
Ocala, Florida, 34474
Ogden Regional Medical Center
Ogden, Utah, 84405
Raulerson Hospital
Okeechobee, Florida, 34972
Orange Park Medical Center
Orange Park, Florida, 32073
Menorah Medical Center
Overland Park, Kansas, 66209
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Gulf Coast Medical Center
Panama City, Florida, 32405
West Florida Hospital
Pensacola, Florida, 32514
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801
Reston Hospital
Reston, Virginia, 20190
Retreat Doctors' Hospital
Richmond, Virginia, 23220
CJW Medical Center (Chippenham Campus)
Richmond, Virginia, 23225
CJW Medical Center (Johnston Willis Campus)
Richmond, Virginia, 23225
Henrico Doctors' Hospital - Forest Campus
Richmond, Virginia, 23229
Henrico Doctors' Hospital - Parham Campus
Richmond, Virginia, 23294
Riverside Community Hospital
Riverside, California, 92501
Redmond Regional Medical Center
Rome, Georgia, 30165
Methodist Hospital
San Antonio, Texas, 78229
Methodist Stone Oak Hospital
San Antonio, Texas, 78229
Northeast Methodist Hospital
San Antonio, Texas, 78229
Regional Medical Center of San Jose
San Jose, California, 95116
Central Florida Regional Hospital
Sanford, Florida, 32771
Doctor's Hospital Sarasota
Sarasota, Florida, 34233
Eastside Medical Center
Snellville, Georgia, 30078
Northside Hospital
St. Petersburg, Florida, 33709
Summerville Medical Center
Summerville, South Carolina, 29485
South Bay Hospital
Sun City Center, Florida, 33573
Mainland Medical Center
Texas City, Texas, 77591
North Suburban Medical Center - JV
Thornton, Colorado, 80229
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Medical Center of Trinity
Trinity, Florida, 34655
Colleton Medical Center
Walterboro, South Carolina, 29488
Clearlake Regional Medical Center
Webster, Texas, 77598
JFK Medical Center - North Campus
West Palm Beach, Florida, 33407
Wesley Medical Center
Wichita, Kansas, 67214
Wesley Woodlawn Hospital
Wichita, Kansas, 67220

Other trials in United States

About this study

Official title: Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response

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

Conditions: Cluster Detection
Being tested: Routine cluster detection, Enhanced cluster detection
Keywords: Hospital Outbreak Detection, Hospital Outbreak Response, Cluster, Multidrug Resistant Organism, Genetic Relatedness, Whole Genome Sequencing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Routine cluster detectionOther
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Enhanced cluster detectionOther
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.

Study groups in NCT04053075
Study group	Role	What they receive
Routine cluster detection	Active comparator	Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. Receives: Other: Routine cluster detection
Enhanced cluster detection	Active comparator	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. Receives: Other: Enhanced cluster detection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 months

Secondary outcomes (1)

Cluster Duration
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.
Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 201920 May 2024

First posted12 Aug 2019
Study start23 Jul 2019
Primary completion20 May 2024
Study completion20 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cluster DetectionStudies of the same condition, open and under way.
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
Model description: Cluster randomized controlled trial
Masking: None (open label)
Enrolment: 2,905,455 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04053075
Sponsor's protocol ID: PH000599B
Acronym: CLUSTER
Status last verified: Dec 2024
First submitted: 8 Aug 2019
Last updated: 16 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38815164

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cluster Detection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response
ClinicalTrials.gov ID: NCT04053075
Acronym / sponsor ID: CLUSTER / PH000599B
Conditions: Cluster Detection
Keywords: Hospital Outbreak Detection, Hospital Outbreak Response, Cluster, Multidrug Resistant Organism, Genetic Relatedness, Whole Genome Sequencing
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,905,455 participants (actual)
Lead sponsor: Harvard Pilgrim Health CareUniversity, hospital or other
Collaborators: Hospital Corporation of America, Brigham and Women's Hospital, University of California, Irvine, Harvard School of Public Health (HSPH), Rush University, Duke University, University of Massachusetts, Amherst, University of California, San Francisco, Cook County Health & Hospitals System, Centers for Disease Control and Prevention
Study start: 23 Jul 2019 (actual)
Primary completion: 20 May 2024 (actual)
Study completion: 20 May 2024 (actual)
First posted: 12 Aug 2019 (actual)
Results: Posted 16 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Cluster randomized controlled trial

Arm	Type	Receives
Routine cluster detection	Active comparator	Other: Routine cluster detectionHospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Enhanced cluster detection	Active comparator	Other: Enhanced cluster detectionHospitals 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

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
Routine cluster detectionHospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.	Other	Routine cluster detection
Enhanced cluster detectionHospitals 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

Primary outcome

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.

1 secondary outcome

Cluster Duration
Time frame: 30 months

Results and safety

Results posted to the registry on 16 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Routine Cluster Detection	1,446,854	1,446,854
Enhanced Cluster Detection	1,458,601	1,458,601

Primary outcome: Cluster Size

Time frame: 30 months. Number (95% Confidence Interval). Unit: outbreak cases after first signal

Measure	Arm 1: Routine Cluster Detection n = 1446854	Arm 2: Enhanced Cluster Detection n = 1458601
Value	1.81 (1.11 to 2.96)	1.41 (0.88 to 2.24)

Population analysed: The total number of participants analyzed reported here is from the intervention period.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Routine Cluster Detection	0 of 1,446,854 (0%)	0 of 1,446,854 (0%)	0 of 1,446,854
Arm 2: Enhanced Cluster Detection	0 of 1,458,601 (0%)	0 of 1,458,601 (0%)	0 of 1,458,601

Limitations and caveats (from the sponsor): \[Not Specified\]

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38815164Baker 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.
Individual participant dataSharing planned: No

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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.

Richard Platt, MD, MSc principal investigator

Harvard Pilgrim Health Care Institute

Susan Huang, MD, MPH principal investigator

University of California, Irvine

Meghan Baker, MD, ScD study director

Brigham and Women's Hospital

82 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Routine cluster detection and Enhanced cluster detection in people with Cluster Detection, run by Harvard Pilgrim Health Care at 82 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 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?

Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Cluster Size (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053075, 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 16 Jan 2025.