A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
Completed · Phase 1
Conditions studied: Bacterial Infections
In brief
The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.
Key facts
- Study ID
- NCT05614895
- Run by
- Hoffmann-La Roche
- People needed
- 48
- Starts
- 2022-12-03
- Expected to finish
- 2024-01-13
- Last updated by the study team
- 2024-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Beaumont Hospital; Royal Oak Pharmacy — Royal Oak, Michigan, United States
- Infectious Disease Associates — Sarasota, Florida, United States
- University of Louisville Physicians — Louisville, Kentucky, United States
- East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville — Greenville, North Carolina, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Centre Hospitalier Régional Universitaire de Lille — Lille, France
- CHU de Limoges - Hôpital Dupuytren — Limoges, France
- Groupe Hospitalier Bichat Claude Bernard — Paris, France
- Hôpital Saint-Louis — Paris, France
- Hôpitaux Universitaires de strasbourg - hôpital civil — Strasbourg, France
- Hadassah Ein Karem Hospital — Jerusalem, Israel
- The Chaim Sheba Medical Center; Multiple Sclerosis Center — Ramat Gan, Israel
- Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel
- ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location — Chisinau, Moldova
- Hallym University Kangnam Sacred Heart Hospital — Seoul, South Korea
- Asan Medical Center. — Seoul, South Korea
Full record on ClinicalTrials.gov
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