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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: RO7223280
* Drug: RO7223280


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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. | Drug: RO7223280<br>* Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.<br>|
| Experimental: Cohort 2<br>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. | Drug: RO7223280<br>* Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.<br>|
| Experimental: Cohort 3<br>Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1. | Drug: RO7223280<br>* Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.<br>|
| Experimental: Cohort 4<br>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. | Drug: RO7223280<br>* Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |