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

Roche

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: RO7223280

Study type: Interventional

Funder types: Industry

Identifiers

NCT05614895

BP43949

ISRCTN21709018 (Registry Identifier)

2022-000456-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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:

  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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: RO7223280

Drug: RO7223280

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: RO7223280

Drug: RO7223280

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: RO7223280

Drug: RO7223280

Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: RO7223280

Drug: RO7223280