A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
- Bacterial Infection
Recruiting
- France
- Israel
- Moldova
- South Korea
- United States
NCT05614895 2022-000456-11, ISRCTN21709018 BP43949
Trial Summary
The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 600 mg RO7223280 in critically ill participants with bacterial infections.
A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections
Eligibility 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. 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.
3. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning
- 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
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