HospitalizationPhase 4PROTECTNCT03118232

Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization

A Phase 4 study testing Chlorhexidine gluconate (CHG) and Iodophor (10% povidone-iodine) in people with Hospitalization and Infection, run by University of California, Irvine at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hospitalization, Infection
What is being tested?: Chlorhexidine gluconate (CHG) and Iodophor (10% povidone-iodine)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13,952 participants
Where: 28 sitesUnited States
Study dates: 3 Apr 2017to 10 Oct 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

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

Other trials in United States

About this study

Conditions: Hospitalization, Infection
Being tested: Chlorhexidine gluconate (CHG), Iodophor (10% povidone-iodine)
Keywords: Nursing Homes, Health Facilities, Infections, Readmissions, Multi-Drug resistance, Antibiotic Use
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03118232
Study group	Role	What they receive
Decolonization	Active comparator	Nursing homes assigned to this arm will perform decolonization using topical antiseptic products. Receives: Drug: Chlorhexidine gluconate (CHG); Drug: Iodophor (10% povidone-iodine)
Routine Bathing	No intervention	Routine bathing per facility protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

Hospital Transfers Due to Infection
Probability that a transfer to a hospital is due to an infection
Measured: 18 months

Secondary outcomes (1)

All Hospital Transfers
Probability that a discharge is to a hospital
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201710 Oct 2023

First posted18 Apr 2017
Study start3 Apr 2017
Primary completion10 Oct 2023
Study completion10 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HospitalizationStudies of the same condition, open and under way.
More trials run by University of California, IrvineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13,952 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03118232
Sponsor's protocol ID: 20151805
Acronym: PROTECT
Status last verified: Dec 2023
First submitted: 21 Feb 2017
Last updated: 27 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.

Publications

Hounmanou YMG, Gussin GM, Conlan S, Singh RD, Deming C, Proctor DM, Teixeira M, Earl AM, Worby CJ, Kong HH, Huang SS, Segre JA. Strain sharing and persistence of microbial pathogens colonizing the skin of residents in a regional nursing home network. Nat Commun. 2026 Jun 18;17(1):7703. doi: 10.1038/s41467-026-74611-x.
PubMed 42315843
Miller LG, McKinnell JA, Singh RD, Gussin GM, Kleinman K, Saavedra R, Mendez J, Catuna TD, Felix J, Chang J, Heim L, Franco R, Tjoa T, Stone ND, Steinberg K, Beecham N, Montgomery J, Walters D, Park S, Tam S, Gohil SK, Robinson PA, Estevez M, Lewis B, Shimabukuro JA, Tchakalian G, Miner A, Torres C, Evans KD, Bittencourt CE, He J, Lee E, Nedelcu C, Lu J, Agrawal S, Sturdevant SG, Peterson E, Huang SS. Decolonization in Nursing Homes to Prevent Infection and Hospitalization. N Engl J Med. 2023 Nov 9;389(19):1766-1777. doi: 10.1056/NEJMoa2215254. Epub 2023 Oct 10.
PubMed 37815935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
ClinicalTrials.gov ID: NCT03118232
Acronym / sponsor ID: PROTECT / 20151805
Conditions: Hospitalization, Infection
Keywords: Nursing Homes, Health Facilities, Infections, Readmissions, Multi-Drug resistance, Antibiotic Use
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 13,952 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Collaborators: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Massachusetts, Amherst, Agency for Healthcare Research and Quality (AHRQ)
Study start: 3 Apr 2017 (actual)
Primary completion: 10 Oct 2023 (actual)
Study completion: 10 Oct 2023 (actual)
First posted: 18 Apr 2017 (actual)
Results: Posted 27 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Decolonization	Active comparator	Drug: Chlorhexidine gluconate (CHG), Drug: Iodophor (10% povidone-iodine)Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Routine Bathing	No intervention	–Routine bathing per facility protocol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Decolonization
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.	Drug	Decolonization

Primary outcome

Hospital Transfers Due to Infection
Time frame: 18 months
Probability that a transfer to a hospital is due to an infection

1 secondary outcome

All Hospital Transfers
Time frame: 18 months

Results and safety

Results posted to the registry on 27 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decolonization	7,388	7,388
Routine Bathing	6,564	6,564

Primary outcome: Hospital Transfers Due to Infection

Time frame: 18 months. Number. Unit: Transfers

Measure	Decolonization n = 7388	Routine Bathing n = 6564
Value	1243	1780

Decolonization vs Routine Bathing: Difference in Risk Ratio: 16.6 (95% CI 11.0 to 21.8), p <0.001, Mixed Models Analysis

Population analysed: Analysis is of residents accounting for clustering in 28 nursing homes

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Decolonization	0 of 7,388 (0%)	35 of 7,388 (0.5%)	0 of 7,388
Routine Bathing	0 of 6,564 (0%)	0 of 6,564 (0%)	0 of 6,564

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42315843Hounmanou YMG, Gussin GM, Conlan S, Singh RD, Deming C, Proctor DM, Teixeira M, Earl AM, Worby CJ, Kong HH, Huang SS, Segre JA. Strain sharing and persistence of microbial pathogens colonizing the skin of residents in a regional nursing home network. Nat Commun. 2026 Jun 18;17(1):7703. doi: 10.1038/s41467-026-74611-x.
Derived from this study: PubMed 37815935Miller LG, McKinnell JA, Singh RD, Gussin GM, Kleinman K, Saavedra R, Mendez J, Catuna TD, Felix J, Chang J, Heim L, Franco R, Tjoa T, Stone ND, Steinberg K, Beecham N, Montgomery J, Walters D, Park S, Tam S, Gohil SK, Robinson PA, Estevez M, Lewis B, Shimabukuro JA, Tchakalian G, Miner A, Torres C, Evans KD, Bittencourt CE, He J, Lee E, Nedelcu C, Lu J, Agrawal S, Sturdevant SG, Peterson E, Huang SS. Decolonization in Nursing Homes to Prevent Infection and Hospitalization. N Engl J Med. 2023 Nov 9;389(19):1766-1777. doi: 10.1056/NEJMoa2215254. Epub 2023 Oct 10.
Individual participant dataSharing planned: No. The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.

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MACE and BTK Inhibitors
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Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Huang, MD MPH principal investigator

University of California, Irvine

Loren Miller, MD MPH study director

Harbor UCLA

James McKinnell, MD study director

Harbor UCLA

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Transfers Due to Infection (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118232, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.