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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

21 Nov 2024 → 4 Dec 2025

Decision date (initial)

2023-01-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Estimate the MRSA decolonization rate 6 hours after nasal application of a topical PVP-I gel.

Secondary objectives 4

1. Evaluate the patient acceptance of a MRSA PVP-I-decolonization kit (nasal, oropharyngeal and body).
2. Describe the characteristics of patients remained MRSA positive after PVP-I decolonization.
3. Evaluate the frequency of adverse reaction associated to PVP-I kit.
4. Estimate the MRSA decolonization rate 24 hours after nasal application of a topical PVP-I gel.

Conditions and MedDRA coding

MRSA patients

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 11

1. Patient < 18 years
2. Patients with a history of thyroid disorders
3. Patient with known intolerance to PVD-I derivatives or excipients
4. Known MRSA colonized patient managed in outpatient or inpatient care but with a negative nasal screen
5. New patient with MRSA infection (this patient can be included later in case of hospital readmission)
6. 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)
7. Adults under guardianship or trusteeship
8. Patients under juridical protection
9. Patients with a known risk of allergy to povidone iodine
10. Patients with damaged skin or mucous
11. Use of mercurial antiseptic during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. MRSA nasal decolonization: Negative nasal screening rate 6 hours after use of the kit

Secondary endpoints 4

1. Acceptability by the patient and HCWs of the use of the complete kit by a satisfactory self-questionnaire
2. Characteristics of patients remained MRSA positive after PVP-I decolonization
3. List of adverse events reported by patients
4. MRSA nasal decolonization: Negative nasal screening rate 24 hours after use of the kit.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Pr Didier LEPELLETIER

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Pr Didier LEPELLETIER

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications