A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections

Phase 1

Completed

Brief 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 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cohort 2	RO7223280	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.
Cohort 3	RO7223280	Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Cohort 4	RO7223280	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.
Cohort 1	RO7223280	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.

Primary Outcome Measures

Name	Time	Method
Plasma Concentrations of RO7223280	Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Percentage of Participants With Serious Adverse Events (SAEs)	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Percentage of Participants Who Died Due to Any Cause	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

Locations (16): East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
🇺🇸
Greenville, North Carolina, United States
Infectious Disease Associates
🇺🇸
Sarasota, Florida, United States
Hallym University Kangnam Sacred Heart Hospital
🇰🇷
Seoul, Korea, Republic of
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
🇲🇩
Chisinau, Moldova, Republic of
Asan Medical Center.
🇰🇷
Seoul, Korea, Republic of
Beaumont Hospital; Royal Oak Pharmacy
🇺🇸
Royal Oak, Michigan, United States
Centre Hospitalier Régional Universitaire de Lille
🇫🇷
Lille, France
Tel-Aviv Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
CHU de Limoges - Hôpital Dupuytren
🇫🇷
Limoges, France
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
University of Louisville Physicians
🇺🇸
Louisville, Kentucky, United States
Hôpital Saint-Louis
🇫🇷
Paris, France
Groupe Hospitalier Bichat Claude Bernard
🇫🇷
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