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 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT04202861
Eligibility Criteria:
Inclusion Criteria:
1. Inpatient at the time of enrolment.
2. Age ≥16 years.
3. An ongoing infection as defined by the published Centers for Disease Control and Prevention (CDC) /National Healthcare Safety Network (NHSN) or Infectious Diseases Society of America (IDSA) guidelines; Section 16.1-16.6 Appendix specifies the most common examples expected in this study.
4. Positive culture of CRGNB isolates from relevant clinical sites (i.e. samples that are not obtained for surveillance purposes, such as rectal swabs)
5. No more than 5 calendar days has elapsed since the first positive culture collection.
Exclusion Criteria:
1. Unable to provide consent AND have no legal representative (LR).
2. Subjects on palliative care or with less than 24 hours of life expectancy (as discussed with their primary physicians).
3. Colonisation only, which is defined as positive isolation of CRGNB isolated at screening sites (e.g., rectal swabs) only
4. Prior recruitment into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04202861
Study Brief:
Protocol Section:
NCT04202861