Multiple Sclerosis Clinical Trial
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 600 mg RO7223280 in critically ill participants with bacterial infections.
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.
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
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There are 16 Locations for this study
Sarasota Florida, 34239, United States
Louisville Kentucky, 40202, United States
Royal Oak Michigan, 48073, United States
Greenville North Carolina, 27858, United States
Portland Oregon, 97239, United States
Lille , 59037, France
Limoges , 87042, France
Paris , 75018, France
Paris , 75475, France
Strasbourg , 67091, France
Jerusalem , 91120, Israel
Ramat-Gan , 52621, Israel
Tel Aviv , 64239, Israel
Seoul , 07441, Korea, Republic of
Seoul , 5505, Korea, Republic of
Chisinau , MD-20, Moldova, Republic of
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