Skip to main content
OpenTrials
Completed

NCT Number: NCT04053075

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cluster Detection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverside Community Hospital, Riverside, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine cluster detection

Other

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

Enhanced cluster detection

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Brigham and Women's Hospital
  • Centers for Disease Control and Prevention
  • Cook County Health & Hospitals System
  • Duke University
  • Harvard School of Public Health (HSPH)
  • Hospital Corporation of America
  • Rush University
  • University of California, Irvine
  • University of California, San Francisco
  • University of Massachusetts, Amherst

Registry information

Official study title

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

Acronym: CLUSTER

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2019
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.