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Completed

NCT Number: NCT05614895

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

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier Régional Universitaire de Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7223280

Drug

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

Primary outcomes

  1. Plasma Concentrations of RO7223280

    Time frame: Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

  2. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

  3. Percentage of Participants Who Died Due to Any Cause

    Time frame: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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