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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05614895

Collaborator

(none)

Enrollment

Locations

Arms

12.7

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Drug: RO7223280	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 3, 2022

Anticipated Primary Completion Date :

Dec 26, 2023

Anticipated Study Completion Date :

Dec 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A 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.	Drug: RO7223280 Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
Experimental: Cohort B 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.	Drug: RO7223280 Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
Experimental: Cohort C Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.	Drug: RO7223280 Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.

Arm

Intervention/Treatment

Experimental: Cohort A

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.

Drug: RO7223280

Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.

Experimental: Cohort B

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.

Drug: RO7223280

Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.

Experimental: Cohort C

Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.

Drug: RO7223280

Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.

Outcome Measures

Primary Outcome Measures

Plasma Concentrations of RO7223280 [From Day 1 up to Day 3]

Secondary Outcome Measures

Percentage of Participants With Adverse Events (AEs) [From Day 1 up to Day 4]
Percentage of Participants With Serious Adverse Events (SAEs) [From Day 1 up to Day 4]
Percentage of Participants Who Died Due to Any Cause [From Day 1 up to Day 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville Physicians	Louisville	Kentucky	United States	40202
2	Beaumont Hospital; Royal Oak Pharmacy	Royal Oak	Michigan	United States	48073
3	East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville	Greenville	North Carolina	United States	27858-4353
4	Oregon Health & Science University	Portland	Oregon	United States	97239
5	Centre Hospitalier Régional Universitaire de Lille	Lille		France	59037
6	CHU de Limoges - Hôpital Dupuytren	Limoges		France	87042
7	Hôpital Saint-Louis	Paris		France	75475
8	Hadassah Ein Karem Hospital	Jerusalem		Israel
9	Asan Medical Center.	Seoul		Korea, Republic of	5505

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT05614895

Other Study ID Numbers:

BP43949
2022-000456-11
ISRCTN21709018

First Posted:

Nov 14, 2022

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Bacterial Infections

Study Results

No Results Posted as of Jan 27, 2023