Multiple Sclerosis Clinical Trial

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

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 600 mg RO7223280 in critically ill participants with bacterial infections.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

48

Study ID:

NCT05614895

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 16 Locations for this study

See Locations Near You

Infectious Disease Associates
Sarasota Florida, 34239, United States
University of Louisville Physicians
Louisville Kentucky, 40202, United States
Beaumont Hospital; Royal Oak Pharmacy
Royal Oak Michigan, 48073, United States
East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
Greenville North Carolina, 27858, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Centre Hospitalier Régional Universitaire de Lille
Lille , 59037, France
CHU de Limoges - Hôpital Dupuytren
Limoges , 87042, France
Groupe Hospitalier Bichat Claude Bernard
Paris , 75018, France
Hôpital Saint-Louis
Paris , 75475, France
Hôpitaux Universitaires de strasbourg - hôpital civil
Strasbourg , 67091, France
Hadassah Ein Karem Hospital
Jerusalem , 91120, Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat-Gan , 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Hallym University Kangnam Sacred Heart Hospital
Seoul , 07441, Korea, Republic of
Asan Medical Center.
Seoul , 5505, Korea, Republic of
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
Chisinau , MD-20, Moldova, Republic of

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

48

Study ID:

NCT05614895

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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