Hospital Transfers Due to Infection
Primary
· 18 months
Probability that a transfer to a hospital is due to an infection
| Group | Value | 95% CI |
|---|---|---|
| Decolonization | 1243 | |
| Routine Bathing | 1780 |
Last reviewed · How we verify
NCT03118232: PROTECT
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Completed
Phase 4
Results posted
Last updated 27 December 2023
What this trial tests
Phase 4 trial testing Chlorhexidine gluconate (CHG) in Hospitalization in 13,952 participants. Completed in 10 October 2023.
Timeline
3 April 2017
Primary endpoint
10 October 2023
10 October 2023
10 October 2023
Quick facts
| Lead sponsor | University of California, Irvine |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 13,952 |
| Start date | 3 April 2017 |
| Primary completion | 10 October 2023 |
| Estimated completion | 10 October 2023 |
| Sites | 28 locations across United States |
Drugs / interventions tested
- Chlorhexidine gluconate (CHG) — full drug profile →
- Iodophor (10% povidone-iodine) — full drug profile →
Conditions studied
- Hospitalization — all drugs for Hospitalization →
- Infection — all drugs for Infection →
Sponsor
University of California, Irvine
Who can join
18 and older, any sex, with Hospitalization or Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All Hospital Transfers
Secondary
· 18 months
Probability that a discharge is to a hospital
| Group | Value | 95% CI |
|---|---|---|
| Decolonization | 2388 | |
| Routine Bathing | 2857 |
Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)
Secondary
· 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)
| Group | Value | 95% CI |
|---|---|---|
| Decolonization | 176 | |
| Routine Bathing | 307 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Decolonization
Serious: 0/7388 (0%)
Deaths: 0/7388
Routine Bathing
Serious: 0/6564 (0%)
Deaths: 0/6564
Other adverse events (2 terms — click to expand)
| Reaction | System | Decolonization | Routine Bathing |
|---|---|---|---|
| Rashes | Product Issues | — | — |
| Sore throat | Product Issues | — | — |
Data from ClinicalTrials.gov NCT03118232 adverse events section.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03118232
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03118232 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Irvine
- Last refreshed: 27 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03118232.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing