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Clinical Trials/NCT03118232
NCT03118232CompletedPhase 4

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

University of California, Irvine28 sites in 1 country13,952 target enrollmentStarted: April 3, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
13,952
Locations
28
Primary Endpoint
Hospital Transfers Due to Infection

Study Overview

Brief Summary

This is a cluster-randomized trial of nursing homes to assess whether decolonization with routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant organism (MDRO) prevalence. The comparator arm will be routine bathing care.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Decolonization

Active Comparator

Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.

Intervention: Chlorhexidine gluconate (CHG) (Drug)

Decolonization

Active Comparator

Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.

Intervention: Iodophor (10% povidone-iodine) (Drug)

Outcomes

Primary Outcomes

Hospital Transfers Due to Infection

Time Frame: 18 months

Probability that a transfer to a hospital is due to an infection

Secondary Outcomes

  • All Hospital Transfers(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Susan Huang

Professor and Medical Director of Epidemiology and Infection Prevention

University of California, Irvine

Study Sites (28)

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