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Evaluation of the Decolonization Rate and Acceptance of a Complete Nasal Decolonization Kit With Povidone Iodine for MRSA Patients

NCT05696132 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-12-23

No results posted yet for this study

Summary

Staphylococcus aureus (S. aureus) is a leading cause of healthcare-associated infections worldwide. S. aureus colonizes several body sites, including the nose, throat, and perineum. Colonization by methicillin-resistant S. aureus (MRSA) increases the risk of infection by up to 27%, with infecting strains matching colonizing strains in up to 86% of cases. Decolonization, the goal of which is to decrease or eliminate bacterial load on the body, is an integral part of the strategies used to control and prevent the spread of MRSA. This approach involves eradication of MRSA carriage from the nose through the intranasal application of an antimicrobial agent and body washes with an antiseptic soap to eliminate bacteria from other body sites. The most commonly used agents for MRSA decolonization are intranasal mupirocin ointment applied to the anterior nares and chlorhexidine body wash. Postdischarge MRSA decolonization with chlorhexidine and mupirocin led to a 30% lower risk of MRSA infection. However, there are growing concerns about decolonization failures following the emergence of mupirocin and chlorhexidine resistance. Povidone iodine (PVP-I) is an alternative decolonization agent solutions and demonstrated rapid and superior bactericidal activity against MRSA in in vitro and ex vivo studies available reports. Finally, the induction of bacterial resistance or cross-resistance to antiseptics and antibiotics with PVP-I was not observed. The present protocol aims to use a "Decolonization kit" into MRSA patients to evaluate the efficacy of MRSA nasal decolonization with a topical PVP-I gel. This kit will allow a complete transient decolonization with povidone-iodine (PVP-I)-based products: nasal (gel), body (antiseptic soap) and oral (mouthwash).

Conditions

  • MRSA

Interventions

DRUG

Betadine

Nasal decolonization with betadine gel

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-12-04
Completion
2025-12-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696132 on ClinicalTrials.gov