ICU Decolonization for Staph Infection

Recruiting in Palo Alto (17 mi)

+136 other locations

Overseen by Richard Platt, MD, MS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Harvard Pilgrim Health Care

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens: Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that enrolled "subjects" represents 137 individual HCA Hospitals (representing \~235 ICUs) that have been randomized.

Research Team

Richard Platt, MD, MS

Principal Investigator

Harvard Pilgrim Health Care Institute

Susan Huang, MD, MPH

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for all adult ICU patients in participating U.S. HCA hospitals, including some rare cases of patients aged 12-18 years. Hospitals with ICUs that have an average stay under 2 days or cannot merge data into a central system are excluded.

Inclusion Criteria

The hospital will be randomly selected for participation, but the study will focus on adults in the intensive care unit (ICU) at that hospital.

All patients within adult ICUs are included, including rare patients <18 years and >=12 years.

Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;

Exclusion Criteria

HCA hospitals that are not able to transfer or merge data into the centralized data warehouse for the baseline and intervention periods of the study are also excluded.

Exclusion criteria includes ICUs with an average length of stay of less than 2 days;

Treatment Details

Interventions

• Iodophor/CHG Decolonization (Antiseptic)
• Mupirocin/CHG (Antibiotic)

Trial Overview The study compares two methods to prevent Staph infections in the ICU: Routine Care using mupirocin and chlorhexidine baths versus an Iodophor-based regimen with chlorhexidine baths. Hospitals are randomly chosen to use one method.

Participant Groups

Group I: Arm 1: Routine Care (Mupirocin/CHG) Active Control 1 Intervention

ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing

Group II: Arm 2: Iodophor/CHG Decolonization Active Control 1 Intervention

ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Hospital Jacksonville Jacksonville, FL

Capital Regional Medical Center Tallahassee, FL

Hendersonville Medical Center Hendersonville, TN

North Austin Medical Center Austin, TX

More Trial Locations

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Patients Recruited

27,990,000+

University of California, Irvine

Collaborator

Trials

580

Patients Recruited

4,943,000+

Rush University

Collaborator

Trials

46

Patients Recruited

3,294,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Patients Recruited

3,474,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Patients Recruited

25,020,000+

Hospital Corporation of America

Industry Sponsor

Trials

8

Patients Recruited

3,433,000+

Hospital Corporation of America

Collaborator

Trials

2

Patients Recruited

428,000+