Bacterial Infections Infections and Infestations
Conditions
Interventions
1. Cohort A - Bacteraemia participants without pneumonia and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280, 600 mg, IV infusion
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment 3. Ongoing clinical syndrome meeting at least one of the following criteria: 3.1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge 3.2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning 3.3. Bacteraemia 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
Exclusion criteria: 1. Ongoing documented catheter-related bacteraemia as the sole ongoing infection 2. Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion 3. Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximum plasma concentration (Cmax) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 2. Time to maximum observed concentration (Tmax) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 3. Observed plasma concentration (Cend) at the end of infusion of RO7223280 measured using plasma samples at day 1 4. Area under the concentration- time curve from time zero to the last measurable concentration (AUClast) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 5. Area under the concentration- time curve extrapolated to infinity (AUC0-8) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 6. Apparent terminal elimination half-life (T1/2) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 7. Terminal rate constant (?z) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 8. Total body clearance (CL) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 9. Volume of distribution at steady state (Vss) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with adverse events (AEs) from screening to follow up period (from day 1 up to day 4) 2. Percentage of participants with serious adverse events (SAEs) from screening to follow up period (from day 1 up to day 4) 3. Percentage of participants who died due to any cause from screening to follow up period (from day 1 up to day 4) | — |
Countries
Brazil, France, Israel, Korea, South, United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed