Clinical trial NCT05614895: A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.


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

Primary outcomes:
measure: Plasma Concentrations of RO7223280
timeFrame: Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
measure: Percentage of Participants Who Died Due to Any Cause
timeFrame: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Infectious Disease Associates
state: Florida
city: Louisville
country: United States
facility: University of Louisville Physicians
state: Kentucky
city: Royal Oak
country: United States
facility: Beaumont Hospital; Royal Oak Pharmacy
state: Michigan
city: Greenville
country: United States
facility: East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
city: Paris
country: France
facility: Groupe Hospitalier Bichat Claude Bernard
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de strasbourg - hôpital civil
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center.
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: