Evaluation of the decolonization rate and acceptance of a complete nasal decolonization kit with povidone iodine for MRSA patients

Phase 1

• Conditions: MRSA patients; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-500642-25-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients readmitted at the Nantes University Hospital and detected to be already MRSA positive by nasal systematic screening, MRSA patients with length of hospital stay > 4 days, Patient older than 18 years and informed about the study, Patients who provide their written informed consent, Patient affiliated with French social security system or beneficiary from such system

Exclusion Criteria

Patient < 18 years, Patients with damaged skin or mucous, Use of mercurial antiseptic during the study, Patients with a history of thyroid disorders, Patient with known intolerance to PVD-I derivatives or excipients, Known MRSA colonized patient managed in outpatient or inpatient care but with a negative nasal screen, New patient with MRSA infection (this patient can be included later in case of hospital readmission), Pregnancy or breastfeeding, patient with childbearing potential that refused acceptable contraceptive method (Acceptable birth control methods that result in a failure rate of more than 1% per year include: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable, but not highly effective, birth control methods), Adults under guardianship or trusteeship, Patients under juridical protection, Patients with a known risk of allergy to povidone iodine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Estimate the MRSA decolonization rate 6 hours after nasal application of a topical PVP-I gel.;Secondary Objective: Evaluate the patient acceptance of a MRSA PVP-I-decolonization kit (nasal, oropharyngeal and body)., Describe the characteristics of patients remained MRSA positive after PVP-I decolonization., Evaluate the frequency of adverse reaction associated to PVP-I kit., Estimate the MRSA decolonization rate 24 hours after nasal application of a topical PVP-I gel.;Primary end point(s): MRSA nasal decolonization: Negative nasal screening rate 6 hours after use of the kit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Acceptability by the patient and HCWs of the use of the complete kit by a satisfactory self-questionnaire;Secondary end point(s):Characteristics of patients remained MRSA positive after PVP-I decolonization;Secondary end point(s):List of adverse events reported by patients;Secondary end point(s):MRSA nasal decolonization: Negative nasal screening rate 24 hours after use of the kit.