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

Primary Purpose

Bacterial Infections

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7223280
RO7223280
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: 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. 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

Sites / Locations

  • Infectious Disease Associates
  • University of Louisville Physicians
  • Beaumont Hospital; Royal Oak PharmacyRecruiting
  • East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
  • Oregon Health & Science University
  • Centre Hospitalier Régional Universitaire de LilleRecruiting
  • CHU de Limoges - Hôpital DupuytrenRecruiting
  • Groupe Hospitalier Bichat Claude BernardRecruiting
  • Hôpital Saint-LouisRecruiting
  • Hôpitaux Universitaires de strasbourg - hôpital civilRecruiting
  • Hadassah Ein Karem HospitalRecruiting
  • The Chaim Sheba Medical Center; Multiple Sclerosis CenterRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Hallym University Kangnam Sacred Heart HospitalRecruiting
  • Asan Medical Center.Recruiting
  • ARENSIA Phase 1 Unit- Spitalul Clinic Republican LocationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

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.

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.

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

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.

Outcomes

Primary Outcome Measures

Plasma Concentrations of RO7223280

Secondary Outcome Measures

Percentage of Participants With Adverse Events (AEs)
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of Participants Who Died Due to Any Cause

Full Information

First Posted
November 10, 2022
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05614895
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2022 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RO7223280
Intervention Description
Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
Intervention Type
Drug
Intervention Name(s)
RO7223280
Intervention Description
Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1.
Primary Outcome Measure Information:
Title
Plasma Concentrations of RO7223280
Time Frame
Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame
Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Title
Percentage of Participants Who Died Due to Any Cause
Time Frame
Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BP43949 https://forpatients.roche.com/
Phone
888-662-6728 (U.S.Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Infectious Disease Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Completed
Facility Name
University of Louisville Physicians
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Completed
Facility Name
Beaumont Hospital; Royal Oak Pharmacy
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4353
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Limoges - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpitaux Universitaires de strasbourg - hôpital civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Hadassah Ein Karem Hospital
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center; Multiple Sclerosis Center
City
Ramat-Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center.
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/).

Learn more about this trial

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

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