A research study to measure RO7223280 levels in participants who have bacterial infections causing severe illness
- Conditions
- Bacterial InfectionsInfections and Infestations
- Registration Number
- ISRCTN21709018
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 27
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method