Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT05696132
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05696132
Study Brief:
Protocol Section:
NCT05696132