Using a nasal kit with Povidone Iodine to reduce MRSA colonization

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

This study tests if a nasal kit with Povidone Iodine can help patients who have MRSA get rid of the bacteria and lower their chances of getting infections again.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 1 site (Nantes)
• Trial ID: NCT05696132 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a complete nasal decolonization kit containing Povidone Iodine for patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). The study focuses on patients who have been readmitted to the Nantes University Hospital and have tested positive for MRSA. The intervention involves applying the antimicrobial agent intranasally and using antiseptic body washes to eliminate MRSA from the body. The goal is to decrease the bacterial load and reduce the risk of subsequent infections.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years who are MRSA positive and have been hospitalized for more than four days.

Not a fit: Patients who are not MRSA positive or those with a shorter hospital stay may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the risk of MRSA infections in colonized patients.

How similar studies have performed: Previous studies have shown that decolonization strategies can effectively reduce MRSA infection rates, indicating potential success for this approach.

Eligibility criteria

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.

Women must meet one of the following criteria at the time of inclusion:

* use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1), and have a negative pregnancy test (urine test) prior to receiving the first dose of study drug;
* or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy)
* or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels
* or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).

Exclusion Criteria:

* Patient \< 18 years,
* 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
* Patients with a known risk of allergy to povidone iodine,
* Patients with damaged skin or mucous,
* Patients with a history of thyroid disorders,
* Adults under guardianship or trusteeship,
* Patients under juridical protection
* Use of mercurial antiseptic during the study.

Where this trial is running

Nantes

• CHU de Nantes — Nantes, France (Recruiting)

Study contacts

• Study coordinator: Didier LEPELLETIER

Conditions MRSA