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Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

NCT03118232 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13952

Last updated 2023-12-27

Study results available
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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.

Conditions

Interventions

DRUG

Chlorhexidine gluconate (CHG)

2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.

DRUG

Iodophor (10% povidone-iodine)

Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • University of Massachusetts, Amherst

    collaborator OTHER

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Susan Huang, MD MPH · University of California, Irvine

  • Loren Miller, MD MPH · Harbor UCLA

  • James McKinnell, MD · Harbor UCLA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2023-10-10
Completion
2023-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118232 on ClinicalTrials.gov