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

December 5, 2023 updated by: Susan Huang, University of California, Irvine
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13952

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92802
        • Buena Vista Care Center
      • Anaheim, California, United States, 92802
        • Walnut Village Rehabilitation and Care Center
      • Anaheim, California, United States, 92804
        • Anaheim Crest Nursing Center
      • Anaheim, California, United States, 92804
        • Sun Mar Nursing Center
      • Anaheim, California, United States, 92804
        • West Anaheim Extended Care
      • Bellflower, California, United States, 90706
        • Bel Tooren Villa Convalescent Hospital
      • Capistrano Beach, California, United States, 92624
        • Capistrano Beach Care Center
      • Downey, California, United States, 90242
        • Downey Care Center
      • Fullerton, California, United States, 92831
        • Gordon Lane Care Center
      • Fullerton, California, United States, 92832
        • Windsor Gardens Care Center of Fullerton
      • Fullerton, California, United States, 92835
        • Terrace View Care Center
      • Garden Grove, California, United States, 92843
        • Pacific Haven Subacute Healthcare Center
      • Gardena, California, United States, 90249
        • Las Flores Convalescent Hospital
      • La Habra, California, United States, 90631
        • Park Regency Care Center
      • Long Beach, California, United States, 90804
        • Regency Oaks Post Acute Care Center
      • Long Beach, California, United States, 90805
        • Windsor Convalescent of North Long Beach
      • Long Beach, California, United States, 90807
        • Bixby Knolls Healthcare Center
      • Long Beach, California, United States, 90807
        • Pacific Villa Inc.
      • Long Beach, California, United States, 90807
        • Vista Cove Care Center at Long Beach
      • Long Beach, California, United States, 90815
        • Intercommunity Care Center
      • Lynwood, California, United States, 90262
        • Royal Oaks Care Center
      • Norwalk, California, United States, 90650
        • Norwalk Skilled Nursing and Wellness Center
      • Norwalk, California, United States, 90650
        • Villa Elena Care Center
      • Torrance, California, United States, 90502
        • Harbor Post-Acute Care Center
      • Torrance, California, United States, 90502
        • Heritage Rehabilitation Center
      • Torrance, California, United States, 90502
        • Sunnyside Nursing Center
      • Torrance, California, United States, 90503
        • Torrance Care Center West
      • Torrance, California, United States, 90505
        • Del Amo Gardens Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital Transfers Due to Infection
Time Frame: 18 months
Probability that a transfer to a hospital is due to an infection
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All Hospital Transfers
Time Frame: 18 months
Probability that a discharge is to a hospital
18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)
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)
Once in baseline and once at end-intervention (month 15-18 of intervention period)
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
18 months
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
18 months
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Massachusetts, Amherst
Agency for Healthcare Research and Quality (AHRQ)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Loren Miller, MD MPH, Harbor UCLA
  • Study Director: James McKinnell, MD, Harbor UCLA
  • Principal Investigator: Susan Huang, MD MPH, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20151805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Clinical Trials on Chlorhexidine gluconate (CHG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings