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Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118232
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
University of Massachusetts, Amherst
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Hospitalization Infection Drug: Chlorhexidine gluconate (CHG) Drug: Iodophor (10% povidone-iodine) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Decolonization
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
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.

No Intervention: Routine Bathing
Routine bathing per facility protocol.



Primary Outcome Measures :
  1. Hospital Transfers Due to Infection [ Time Frame: 18 months ]
    Probability that a transfer to a hospital is due to an infection


Secondary Outcome Measures :
  1. All Hospital Transfers [ Time Frame: 18 months ]
    Probability that a discharge is to a hospital


Other Outcome Measures:
  1. Multidrug-resistant organism (MDRO) colonization (Secondary manuscript, Original protocol) [ Time Frame: Once in baseline and once at end-intervention (month 15-18 of intervention period) ]
    Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)

  2. Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary manuscript, added by Steering Committee decision on 3/22/2017) [ Time Frame: 18 months ]
    Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets

  3. All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary manuscript, added by Steering Committee decision on 3/22/2017) [ Time Frame: 18 months ]
    Probability that a discharge is to a hospital for long stay and short stay resident subsets

  4. Emergency Department Transfers Due to Infection (Secondary manuscript, added by Steering Committee decision on 3/22/2017) [ Time Frame: 18 months ]
    Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <15% of residents receiving at least one chlorhexidine bath or nasal decolonization treatment during their nursing home stay.

Exclusion Criteria

Nursing homes will not be eligible to participate if they meet the following criteria:

  • Facilities routinely using decolonization
  • Dedicated psychiatric nursing homes
  • Facilities with a resident population with >=20% combative patients
  • Pediatric facilities

Note: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118232


Locations
Show Show 28 study locations
Sponsors and Collaborators
University of California, Irvine
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
University of Massachusetts, Amherst
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Susan Huang, MD MPH University of California, Irvine
Study Director: Loren Miller, MD MPH Harbor UCLA
Study Director: James McKinnell, MD Harbor UCLA
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Responsible Party: Susan Huang, Professor and Medical Director of Epidemiology and Infection Prevention, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03118232    
Other Study ID Numbers: 2015-1805
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Huang, University of California, Irvine:
Nursing Homes
Health Facilities
Infections
Readmissions
Multi-Drug resistance
Antibiotic Use
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Plasma Substitutes
Blood Substitutes