Phase 4
N=13,952
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Hospitalization · Infection
Bottom Line
View on ClinicalTrials.gov: NCT03118232 ↗Enrolled (actual)
13,952
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Hospital Transfers Due to Infection — 1243; 1780 Transfers — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Chlorhexidine gluconate (CHG) (Drug); Iodophor (10% povidone-iodine) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Transfers Due to Infection |
1243; 1780 | <0.001 sig |
| SECONDARY All Hospital Transfers |
2388; 2857 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
Nursing homes will be eligible to participate if they meet the following criteria:
- Licensed nursing home in Orange County or Southern Los Angeles County serving adults
- Minimal use of chlorhexidine bathing*
- Minimal use of nasal decolonization* *Minimal use defined as =20% combative patients
- Pediatric facilities
Note: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded
Data sourced from ClinicalTrials.gov (NCT03118232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.