CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13,952 enrolled
Drug / intervention
Chlorhexidine gluconate (CHG) +1 moredrug
Likely dose
2% chlorhexidine gluconate for bed bathing and 4% rinse-off chlorhexidine gluconate for showering; 10% povidone-iodine nasal swabs applied twice daily for 5 days on admission then twice daily Monday-Friday every other weekAI-extracted
Key inclusion· 3
  • ✓Licensed nursing home located in Orange County or Southern Los Angeles County
  • ✓Minimal prior use of chlorhexidine bathing (less than 15% of residents)
  • ✓Minimal prior use of nasal decolonization (less than 15% of residents)
Key exclusion· 5
  • ✕Facility routinely uses decolonization protocols
  • ✕Dedicated psychiatric nursing home
  • ✕Facility with ≥20% combative patient population
  • ✕Pediatric facility

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03118232
NCT03118232Phase 4Completed
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Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

University of California, Irvine·interventional·Posted Apr 18, 2017·Updated Dec 27, 2023

In Brief

A Phase 4 clinical trial evaluating Chlorhexidine gluconate (CHG) and Iodophor (10% povidone-iodine) for Hospitalization and Infection. Completed, enrolled 13,952 participants across 28 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHospitalization, Infection
CountriesUnited States
CollaboratorsLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Massachusetts, Amherst, Agency for Healthcare Research and Quality (AHRQ)

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartApr 3, 2017
Primary CompletionOct 10, 2023
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 9.2 years ago

Interventions

Chlorhexidine gluconate (CHG)drug

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

Iodophor (10% povidone-iodine)drug

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.