A research study to measure RO7223280 levels in participants who have bacterial infections causing severe illness
| ISRCTN | ISRCTN21709018 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21709018 |
| EudraCT/CTIS number | 2022-000456-11 |
| ClinicalTrials.gov number | NCT05614895 |
| Secondary identifying numbers | BP43949 |
- Submission date
- 21/06/2022
- Registration date
- 22/06/2022
- Last edited
- 04/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Nosocomial bacterial pneumonia is an infection of the lungs. Bacteraemia is an infection of the blood. Both are severe invasive infections caused by bacteria. The drug under study (RO7223280) is being developed for the possible treatment of such infections. RO7223280 is an experimental drug i.e., the Health Authorities (like the U.S Food and Drug Administration and European Medicines Agency) have not approved RO7223280 for the treatment of infections. The main purpose of this study is: -
1. To measure the drug levels in the body
2. To determine the safety of the drug
Who can participate?
Patients who are aged 18 years old and over and are critically ill because of hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteraemia.
What does the study involve?
The maximum length of participation in the study is about 9 days.
The study will include:
1. Screening period: The screening period will last up to 5 days. All participants will be screened to make sure they are a good fit for the study.
2. Treatment period: All participants will receive a single dose of 600 mg of RO7223280 over 1 hour through a needle put into a vein in the arm (infusion) on Day 1. The participants will have to stay in the hospital during the treatment. Some blood samples will be taken on Day 1.
3. Safety Follow-up Period: Additional blood samples will be taken on Days 2 and 3. Participants will have a check-up on Days 2 to 4 after the treatment period.
What are the possible benefits and risks of participating?
Participants may not receive any health benefits from participating in this study, but the information learned in this study may help patients with similar conditions in the future. Participants may experience side effects from the study drug, and these can be mild to severe and can vary from person to person. RO7223280 has had limited testing in humans. The known side effects of this drug, as well as potential side effects, are listed below. There may potentially also be side effects that are not known at this time.
1. Itching
2. Flushing
3. Shortness of breath
4. Headache
5. Skin inflammation
6. Skin bruising
There may be a risk in exposing an unborn child to the study drug, and all risks are not known at this time. Women and men must take precautions to avoid exposing an unborn child to the study drug. Participants who are pregnant, become pregnant, or are currently breastfeeding cannot take part in this study.
Where is the study run from?
F. Hoffmann-La Roche Ltd (USA)
When is the study starting and how long is it expected to run for?
December 2021 to December 2023
Who is funding the study?
F. Hoffmann-La Roche Ltd (USA)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Public
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Multicentre single-dose uncontrolled open-label phase Ib study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific 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 objectives | The main aim of the study is to investigate the plasma pharmacokinetic (PK) and safety of intravenous (IV) administration of a single dose of 600 mg RO7223280 in critically ill participants with bacterial infections |
| Ethics approval(s) | Approved 06/05/2022, WCG IRB (1019 39th Avenue, SE Suite 120 Puyallup, WA 98374, USA; +1 855 818 2289; clientservices@wcgirb.com), ref: 1-1540488-1 |
| Health condition(s) or problem(s) studied | Bacterial Infections |
| Intervention | 1. Cohort A - Bacteraemia participants without pneumonia and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1. 2. Cohort B – 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, 600 mg, IV infusion for 1 hour on Day 1. 3. Cohort C – Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | RO7223280 |
| Primary outcome measure | 1. Maximum plasma concentration (Cmax) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 2. Time to maximum observed concentration (Tmax) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 3. Observed plasma concentration (Cend) at the end of infusion of RO7223280 measured using plasma samples at day 1 4. Area under the concentration- time curve from time zero to the last measurable concentration (AUClast) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 5. Area under the concentration- time curve extrapolated to infinity (AUC0-∞) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 6. Apparent terminal elimination half-life (T1/2) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 7. Terminal rate constant (λz) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 8. Total body clearance (CL) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 9. Volume of distribution at steady state (Vss) of RO7223280 measured using plasma samples at multiple timepoints from day 1 to day 3 |
| Secondary outcome measures | 1. Percentage of participants with adverse events (AEs) from screening to follow up period (from day 1 up to day 4) 2. Percentage of participants with serious adverse events (SAEs) from screening to follow up period (from day 1 up to day 4) 3. Percentage of participants who died due to any cause from screening to follow up period (from day 1 up to day 4) |
| Overall study start date | 15/12/2021 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 27 |
| Key inclusion criteria | 1. Aged 18 years old and over 2. Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment 3. Ongoing clinical syndrome meeting at least one of the following criteria: 3.1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge 3.2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning 3.3. Bacteraemia 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. |
| Key exclusion criteria | 1. Ongoing documented catheter-related bacteraemia as the sole ongoing infection 2. Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion 3. Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary |
| Date of first enrolment | 30/06/2022 |
| Date of final enrolment | 22/12/2023 |
Locations
Countries of recruitment
- Brazil
- France
- Israel
- Korea, South
- United States of America
Study participating centres
905 - Centro
Tatuí
18270-170
Brazil
90035-903
Brazil
185 - Garcia
Salvador
40110-160
Brazil
91 - Luxemburgo
Belo Horizonte
30380-420
Brazil
67000
France
87042
France
75015
France
75018
France
59037
France
13100
Israel
2210001
Israel
Tel HaShomer
5266202
Israel
6423906
Israel
91120
Israel
138-736
Korea, South
07441
Korea, South
97239
United States of America
Royal Oak
48073-6712
United States of America
Greenville
27858
United States of America
48202-2608
United States of America
40202-5703
United States of America
43608
United States of America
Sponsor information
Industry
1 DNA Way
South San Francisco
94080
United States of America
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement |
Editorial Notes
04/12/2023: The following changes were made:
1. Study website added.
2. ClinicalTrials.gov number added.
22/06/2022: Trial's existence confirmed by WCG IRB.
