← Back to all trials
Recruiting
NCT05614895
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
Conditions: Bacterial Infections
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 27
Sponsor: Hoffmann-La Roche
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Illness requiring treatment in an intensive care unit (ICU) at the time of enrolmentOngoing clinical syndrome meeting at least one of the following criteria:HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital dischargeVentilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaningBacteremia 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.Exclusion Criteria:Ongoing documented catheter-related bacteraemia as the sole ongoing infectionMajor surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusionKnown chronic severe hepatic impairment (Child-Pugh class C).
Note: acute severe hepatic impairment is not exclusionary
Source: ClinicalTrials.gov (NCT05614895). StuddyBuddy aggregates publicly available trial information.