Bacterial InfectionsPhase 1NCT05614895
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
A Phase 1 study testing RO7223280 in people with Bacterial Infections, run by Hoffmann-La Roche at 16 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- RO7223280
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 3 Dec 2022to 13 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States5 sites
East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville
Greenville, North Carolina, 27858-4353
University of Louisville Physicians
Louisville, Kentucky, 40202
Oregon Health & Science University
Portland, Oregon, 97239
Beaumont Hospital; Royal Oak Pharmacy
Royal Oak, Michigan, 48073
Infectious Disease Associates
Sarasota, Florida, 34239
France5 sites
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
Hôpital Saint-Louis
Paris, 75475
Hôpitaux Universitaires de strasbourg - hôpital civil
Strasbourg, 67091
Israel3 sites
Hadassah Ein Karem Hospital
Jerusalem, 9112001
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat Gan, 5262100
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
South Korea2 sites
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Asan Medical Center.
Seoul, 5505
Moldova1 site
ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location
Chisinau, MD-2025
About this study
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
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.
- Conditions
- Bacterial Infections
- Being tested
- RO7223280
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7223280Drug
Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.
RO7223280Drug
Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: RO7223280 |
| Cohort 3 | Experimental | Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1. Receives: 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. Receives: Drug: RO7223280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentrations of RO7223280
Measured: 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)
Measured: 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)
Measured: 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
Measured: Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start3 Dec 2022
- Primary completion13 Jan 2024
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614895
- Sponsor's protocol ID
- BP43949
- Other IDs
- 2022-000456-11, ISRCTN21709018
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/).
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05614895
- Acronym / sponsor ID
- BP43949
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RO7223280Bacteremia 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 | Experimental | Drug: RO7223280Participants 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 3 | Experimental | Drug: RO7223280Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1. |
| Cohort 4 | Experimental | Drug: RO7223280Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7223280Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| RO7223280Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1. | Drug | Cohort 4 |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Yes. 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7223280 in people with Bacterial Infections, run by Hoffmann-La Roche at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, France, Israel, South Korea, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.