A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
NCT ID: NCT05614895
Last Updated: 2024-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2022-12-03
2024-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
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.
RO7223280
Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
Cohort 2
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.
RO7223280
Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
Cohort 3
Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
RO7223280
Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
Cohort 4
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.
RO7223280
Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1.
Interventions
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RO7223280
Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
RO7223280
Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1.
Eligibility Criteria
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Inclusion Criteria
* Ongoing clinical syndrome meeting at least one of the following criteria:
1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge
2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning
3. 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.
4. 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Infectious Disease Associates
Sarasota, Florida, United States
University of Louisville Physicians
Louisville, Kentucky, United States
Beaumont Hospital; Royal Oak Pharmacy
Royal Oak, Michigan, United States
East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
Greenville, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Centre Hospitalier Régional Universitaire de Lille
Lille, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
Groupe Hospitalier Bichat Claude Bernard
Paris, , France
Hôpital Saint-Louis
Paris, , France
Hôpitaux Universitaires de strasbourg - hôpital civil
Strasbourg, , France
Hadassah Ein Karem Hospital
Jerusalem, , Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
Chisinau, , Moldova
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Asan Medical Center.
Seoul, , South Korea
Countries
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Other Identifiers
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2022-000456-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISRCTN21709018
Identifier Type: REGISTRY
Identifier Source: secondary_id
BP43949
Identifier Type: -
Identifier Source: org_study_id
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