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

Bacterial Infections Clinical Trial

Official title:

A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614895
• Other study ID #: BP43949
• Secondary ID: 2022-000456-11IS
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2022
• Est. completion date: January 13, 2024

Study information

• Verified date: January 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 13, 2024
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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:

• 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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	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
Israel	Hadassah Ein Karem Hospital	Jerusalem
Israel	The Chaim Sheba Medical Center; Multiple Sclerosis Center	Ramat-Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Korea, Republic of	Asan Medical Center.	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Moldova, Republic of	ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location	Chisinau
United States	East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville	Greenville	North Carolina
United States	University of Louisville Physicians	Louisville	Kentucky
United States	Oregon Health & Science University	Portland	Oregon
United States	Beaumont Hospital; Royal Oak Pharmacy	Royal Oak	Michigan
United States	Infectious Disease Associates	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Israel,  Korea, Republic of,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentrations of RO7223280		Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5
Secondary	Percentage of Participants With Adverse Events (AEs)		Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Secondary	Percentage of Participants With Serious Adverse Events (SAEs)		Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Secondary	Percentage of Participants Who Died Due to Any Cause		Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5