NCT03118232

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13,952 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Hospitalization
• Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-03
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2017-04-18
• Last updated: 2023-12-27
• Results posted: 2023-12-27

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study