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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT04781569
Eligibility Criteria:
Inclusion criteria for patients:
* In collaboration with the orthopedic surgeons, patients with probable or proven S. aureus infections will be identified who will routinely undergo diagnostic and surgical procedures:
Inclusion criteria for healthy participants:
* Healthy control group should be generally well-being
Exclusion criteria for patients and for healthy participants:
* Pregnancy: Pregnant or lactating women will be excluded (urinary pregnancy test will be performed in women of childbearing age)
* General health condition: Current or recurrent disease that could cause complications that may affect the study or may set the patient at risk
* Diseases/ Illness: Psychiatric or other mental disorders which in the opinion of the investigator may probably affect the full understanding of the study (including signs of dementia)
* Language: Insufficient knowledge of german language to understand the procedure and rationale of the research question
* Vulnerability: Individuals whose willingness to volunteer in the research project may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, such as members of a group with a direct hierarchical structure (refer to ICH Guidelines E6 (R1) for GCP, 1.61)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04781569
Study Brief:
Protocol Section:
NCT04781569