Evaluation of the decolonization rate and acceptance of a complete nasal decolonization kit with povidone iodine for MRSA patients (MRSAD-PVP-I)

The primary objective of this study is to estimate the **MRSA** decolonization rate 6 hours after the nasal application of a topical **PVP-I** gel. This is clinically relevant as it aims to determine the efficacy of the povidone-iodine gel in rapidly reducing **MRSA** colonization, which is crucial for preventing the spread of this resistant bacterium in healthcare settings.

Secondary objectives include:

• Evaluating patient acceptance of a **MRSA** **PVP-I**-decolonization kit, which includes nasal, oropharyngeal, and body applications.
• Describing the characteristics of patients who remain **MRSA** positive after **PVP-I** decolonization.
• Evaluating the frequency of adverse reactions associated with the **PVP-I** kit.
• Estimating the **MRSA** decolonization rate 24 hours after nasal application of the topical **PVP-I** gel.

The clinical trial involves **MRSA patients** who are readmitted to the Nantes University Hospital and have been detected as MRSA positive through nasal systematic screening. The study population includes both male and female participants, aged 18 years and older. Participants are required to have a hospital stay longer than four days and must be informed about the study, providing written informed consent. Additionally, they must be affiliated with the French social security system or be beneficiaries of it. The trial includes a vulnerable population, but the total number of participants is not provided by the sponsor. The selection criteria focus on individuals who meet the specified health and administrative conditions, ensuring a targeted and relevant study group for estimating the MRSA decolonization rate following the application of a topical PVP-I gel.

The clinical trial is designed to evaluate the **decolonization** rate and acceptance of a complete nasal decolonization kit containing **povidone iodine** for patients with Methicillin-resistant Staphylococcus aureus (MRSA). This trial is a Phase IV, low-intervention study, conducted in accordance with the marketing authorization terms in France. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is from November 21, 2024, to January 2, 2025, with recruitment starting on November 21, 2024.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as being MRSA positive, having a hospital stay longer than four days, being over 18 years old, and providing informed consent. The primary endpoint is the MRSA nasal decolonization rate, assessed six hours after the application of the topical PVP-I gel. Secondary endpoints include patient and healthcare worker acceptability of the kit, characteristics of patients who remain MRSA positive, and a list of adverse events reported by participants. Follow-up visits will be scheduled to monitor these endpoints, with a final end-of-study visit to conclude participation.

The expected length of participant involvement is approximately six weeks, depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or non-compliance with study procedures. The trial aims to provide valuable insights into the effectiveness and acceptability of povidone iodine in MRSA decolonization, contributing to improved patient outcomes and infection control practices.

The clinical trial involves the use of **BETADINE 10 POUR CENT, solution pour bain de bouche**, which is a mouthwash formulation containing the active substance **povidone, iodinated**. This pharmaceutical form is intended for **buccal use**. The maximum daily dose is set at one dosage form, with a total treatment period of one day. The administration is conducted under controlled conditions to ensure participant compliance and accurate monitoring of the treatment effects.

Another treatment in the trial is **BETADINE 10 POUR CENT, gel**, which is a gel formulation also containing **povidone, iodinated**. This product is designed for **nasal use**. Similar to the mouthwash, the maximum daily dose is one dosage form, and the treatment period is limited to one day. The gel is applied topically to the nasal area, and participant adherence to the dosing schedule is closely monitored to ensure the integrity of the trial data.

The trial also includes the use of **BETADINE SCRUB 4 POUR CENT, solution pour application cutanée (moussante)**, a cutaneous solution with a foaming property, containing **povidone, iodinated**. This formulation is intended for **cutaneous use**. The dosing regimen is consistent with the other products, with a maximum daily dose of one dosage form and a treatment period of one day. The application is performed under supervision to maintain consistency and reliability in the trial outcomes.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in this trial. The focus is on evaluating the decolonization rate and acceptance of the povidone iodine formulations in patients with Methicillin-resistant Staphylococcus aureus (MRSA). Compliance with the treatment protocol is ensured through structured monitoring and documentation of each participant's adherence to the prescribed dosing schedule.

Efficacy in this clinical trial will be assessed primarily by evaluating the **MRSA** nasal decolonization rate. The primary endpoint is the negative nasal screening rate 6 hours after the application of a topical PVP-I gel. Secondary endpoints include the acceptability of the complete kit by patients and healthcare workers, assessed through a satisfactory self-questionnaire, characteristics of patients who remain MRSA positive after PVP-I decolonization, a list of adverse events reported by patients, and the negative nasal screening rate 24 hours after the use of the kit. These assessments will provide comprehensive data on the efficacy of the treatment in achieving MRSA decolonization and its acceptability among users.