NCT05614895

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2022

Geographic Reach
5 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

December 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

November 10, 2022

Last Update Submit

January 19, 2024

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Plasma Concentrations of RO7223280

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

Secondary Outcomes (3)

  • 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

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.

Drug: RO7223280

Cohort 2

EXPERIMENTAL

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.

Drug: RO7223280

Cohort 3

EXPERIMENTAL

Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.

Drug: RO7223280

Cohort 4

EXPERIMENTAL

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.

Drug: RO7223280

Interventions

RO7223280DRUG

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Infectious Disease Associates

Sarasota, Florida, 34239, United States

Location

University of Louisville Physicians

Louisville, Kentucky, 40202, United States

Location

Beaumont Hospital; Royal Oak Pharmacy

Royal Oak, Michigan, 48073, United States

Location

East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville

Greenville, North Carolina, 27858-4353, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

CHU de Limoges - Hôpital Dupuytren

Limoges, 87042, France

Location

Groupe Hospitalier Bichat Claude Bernard

Paris, 75018, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

Hôpitaux Universitaires de strasbourg - hôpital civil

Strasbourg, 67091, France

Location

Hadassah Ein Karem Hospital

Jerusalem, 9112001, Israel

Location

The Chaim Sheba Medical Center; Multiple Sclerosis Center

Ramat Gan, 5262100, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location

Chisinau, MD-2025, Moldova

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Asan Medical Center.

Seoul, 5505, South Korea

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 14, 2022

Study Start

December 3, 2022

Primary Completion

January 13, 2024

Study Completion

January 13, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical -trials/data-sharing/).

Locations

FR(5)KR(2)US(5)IL(3)MO(1)