A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
Bacterial Infections
About this trial
This is an interventional treatment trial for Bacterial Infections
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: HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning 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. 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
Sites / Locations
- Infectious Disease Associates
- University of Louisville Physicians
- Beaumont Hospital; Royal Oak PharmacyRecruiting
- East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
- Oregon Health & Science University
- Centre Hospitalier Régional Universitaire de LilleRecruiting
- CHU de Limoges - Hôpital DupuytrenRecruiting
- Groupe Hospitalier Bichat Claude BernardRecruiting
- Hôpital Saint-LouisRecruiting
- Hôpitaux Universitaires de strasbourg - hôpital civilRecruiting
- Hadassah Ein Karem HospitalRecruiting
- The Chaim Sheba Medical Center; Multiple Sclerosis CenterRecruiting
- Tel-Aviv Sourasky Medical CenterRecruiting
- Hallym University Kangnam Sacred Heart HospitalRecruiting
- Asan Medical Center.Recruiting
- ARENSIA Phase 1 Unit- Spitalul Clinic Republican LocationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Bacteremia participants without pneumonia and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Participants with hospital-acquired bacterial pneumonia (HABP) and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Participants with mechanical ventilation who have a bronchoalveolar lavage (BAL) planned as a part of routine practice will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.