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

  • Bacterial Infection
Trial Status:

Recruiting

This trial runs in
Countries
  • United States
Trial Identifier:

NCT05614895 2022-000456-11, ISRCTN21709018 BP43949

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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 600 mg RO7223280 in critically ill participants with bacterial infections.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT05614895 , BP43949 , 2022-000456-11, ISRCTN21709018 Trial Identifier
      RO7223280 Treatments
      Bacterial Infections Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      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.

      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

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