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

NCT05614895

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Bacterial Infections

Interventions: RO7223280, RO7223280

Countries: United States, France, Israel, Moldova, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (16)
  • Sarasota, Florida, United States
  • Louisville, Kentucky, United States
  • Royal Oak, Michigan, United States
  • Greenville, North Carolina, United States
  • Portland, Oregon, United States
  • Lille, France
  • Limoges, France
  • Paris, France
  • Paris, France
  • Strasbourg, France
  • Jerusalem, Israel
  • Ramat Gan, Israel
  • Tel Aviv, Israel
  • Chisinau, Moldova
  • Seoul, South Korea
  • Seoul, South Korea