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

Phase 1

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: RO7223280

• Registration Number: NCT05614895
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-14
• Study Start: 2022-12-03
• Status Verified: 2024-01
• Primary Completion: 2024-01-13
• Study Completion: 2024-01-13
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	RO7223280	Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Cohort 1	RO7223280	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.
Cohort 2	RO7223280	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.
Cohort 4	RO7223280	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.

Primary Outcome Measures

Name	Time	Method
Plasma Concentrations of RO7223280	Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Percentage of Participants With Serious Adverse Events (SAEs)	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Percentage of Participants Who Died Due to Any Cause	Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

Trial Locations

Locations (16)

East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville; 🇺🇸 Greenville, North Carolina, United States

Infectious Disease Associates; 🇺🇸 Sarasota, Florida, United States

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location; 🇲🇩 Chisinau, Moldova, Republic of

Asan Medical Center.; 🇰🇷 Seoul, Korea, Republic of

Beaumont Hospital; Royal Oak Pharmacy; 🇺🇸 Royal Oak, Michigan, United States

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

CHU de Limoges - Hôpital Dupuytren; 🇫🇷 Limoges, France

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Louisville Physicians; 🇺🇸 Louisville, Kentucky, United States

Hôpital Saint-Louis; 🇫🇷 Paris, France

Groupe Hospitalier Bichat Claude Bernard; 🇫🇷 Paris, France

Hôpitaux Universitaires de strasbourg - hôpital civil; 🇫🇷 Strasbourg, France

Hadassah Ein Karem Hospital; 🇮🇱 Jerusalem, Israel

The Chaim Sheba Medical Center; Multiple Sclerosis Center; 🇮🇱 Ramat-Gan, Israel