A Phase 4 interventional study of Chlorhexidine gluconate (CHG) and Iodophor (10% povidone-iodine) in Hospitalization and Infection, sponsored by University of California, Irvine. Completed at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by University of California, Irvine · Phase 4, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 13,952 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Nursing homes will be eligible to participate if they meet the following criteria:
Exclusion Criteria
Nursing homes will not be eligible to participate if they meet the following criteria:
Note: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Drug: Chlorhexidine gluconate (CHG) · Drug: Iodophor (10% povidone-iodine)
Routine bathing per facility protocol.
2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
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.
Hospital Transfers Due to Infection
Probability that a transfer to a hospital is due to an infection
Time frame: 18 months
All Hospital Transfers
Probability that a discharge is to a hospital
Time frame: 18 months
Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)
Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)
Time frame: 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)
Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets
Time frame: 18 months
All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
Probability that a discharge is to a hospital for long stay and short stay resident subsets
Time frame: 18 months
Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)
Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets
Time frame: 18 months
| Milestone | Decolonization | Routine Bathing |
|---|---|---|
| Started | 7388 | 6564 |
| Completed | 7388 | 6564 |
| Not completed | 0 | 0 |
Probability that a transfer to a hospital is due to an infection
| Transfers | Decolonization | Routine Bathing |
|---|---|---|
| Hospital Transfers Due to Infection | 1243 | 1780 |
Probability that a discharge is to a hospital
| Transfers | Decolonization | Routine Bathing |
|---|---|---|
| All Hospital Transfers | 2388 | 2857 |
Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)
| Participants | Decolonization | Routine Bathing |
|---|---|---|
| Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript) | 176 | 307 |
Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets
Results for this outcome have not been posted.
Probability that a discharge is to a hospital for long stay and short stay resident subsets
Results for this outcome have not been posted.
Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets
Results for this outcome have not been posted.
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decolonization | 0/7,388 (0%) | 0/7,388 (0%) | 35/7,388 (0.5%) |
| Routine Bathing | 0/6,564 (0%) | 0/6,564 (0%) | 0/6,564 (0%) |
| Event | Decolonization | Routine Bathing |
|---|---|---|
| RashesProduct Issues | 34/7388 | 0/6564 |
| Sore throatProduct Issues | 1/7388 | 0/6564 |
| Age, Continuous(years) | Decolonization | Routine Bathing | Total |
|---|---|---|---|
| Mean | 75.7 ± 4.2 | 76.6 ± 5.8 | 76.2 ± 5.0 |
| Sex: Female, Male(Participants) | Decolonization | Routine Bathing | Total |
|---|---|---|---|
| Female | 4180 | 3602 | 7782 |
| Male | 3208 | 2962 | 6170 |
| Race (NIH/OMB)(Participants) | Decolonization | Routine Bathing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1042 | 1312 | 2354 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 841 | 1042 | 1883 |
| White | 3749 | 2666 | 6415 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1756 | 1544 | 3300 |
| Region of Enrollment(Participants) | Decolonization | Routine Bathing | Total |
|---|---|---|---|
| United States | 7388 | 6564 | 13952 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of California, Irvine