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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT05614895
Eligibility Criteria:
Inclusion Criteria:
* Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment
* Ongoing clinical syndrome meeting at least one of the following criteria:
1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge
2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning
3. Bacteremia confirmed by the presence of a bacterial pathogen in a blood culture drawn within 7 days prior to dosing and with the defined focus of infection.
4. For Cohort 4 only: mechanically ventilated participants who have a BAL procedure planned as part of routine practice for a day that can function as Day 1.
Exclusion Criteria:
* Ongoing documented catheter-related bacteraemia as the sole ongoing infection
* Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion
* Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05614895
Study Brief:
Protocol Section:
NCT05614895