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NCT03140423 · ClinicalTrials.gov registry record · Phase 4

Mupirocin-Iodophor ICU Decolonization Swap Out Trial

A Phase 4 study, sponsored by Harvard Pilgrim Health Care.

Completed
Registry status
Phase 4
Development phase
353,323
Enrollment target

NCT03140423: Completed Phase 4 study, sponsored by Harvard Pilgrim Health Care.

NCT03140423 is a Phase 4 study that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 353,323 participants, above the 480-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73509% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03140423, a Phase 4 study, has completed, sponsored by Harvard Pilgrim Health Care.

COMPLETED
Registry status
Phase 4
Development phase
353,323 participants
Enrollment target

Study Summary

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.

Primary Outcome

Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) clinical cultures attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.

Interventions

  • DRUG Arm 1. Routine Care (Mupirocin/CHG)
  • DRUG Arm 2. Iodophor/CHG Decolonization

Trial Details

FieldValue
Enrollment Target 353,323 participants
Start Date 2017-05-01
Est. Completion 2023-11-06
Phase Phase 4
Harvard Pilgrim Health Care

28 total trials

What the finished NCT03140423 record still lists

NCT03140423 is an interventional study that assigns participants to a tested intervention. Its 353,323 participants enrollment target places it among the larger protocols in the corpus, above the 480-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73509% higher).

The record links to 0 conditions, and to 2 interventions - of which Arm 1. Routine Care (Mupirocin/CHG) is the first listed.

NCT03140423 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03140423 about?

NCT03140423 is a clinical study titled "Mupirocin-Iodophor ICU Decolonization Swap Out 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 ...

What is the current status of trial NCT03140423?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 353,323 participants. The study started on 2017-05-01. Estimated completion is 2023-11-06.

What interventions are being tested in trial NCT03140423?

The interventions under investigation include: Arm 1. Routine Care (Mupirocin/CHG) (DRUG), Arm 2. Iodophor/CHG Decolonization (DRUG).

Who is sponsoring clinical trial NCT03140423?

This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03140423's enrollment target sits among peer trials

353,323 3rd of 2000 higher than 1,998 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03140423, the US trial registry maintained by the National Library of Medicine. NCT03140423 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.