Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000456-11 | EudraCT Number | ||
| ISRCTN21709018 | Registry Identifier | ISRCTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Cohort 3 | Experimental | Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7223280 | Drug | Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of RO7223280 | Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Associates | Sarasota | Florida | 34239 | United States | ||
| University of Louisville Physicians |
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/).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RO7223280 | Drug | Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1. |
|
| 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 |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Beaumont Hospital; Royal Oak Pharmacy | Royal Oak | Michigan | 48073 | United States |
| East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville | Greenville | North Carolina | 27858-4353 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Centre Hospitalier Régional Universitaire de Lille | Lille | 59037 | France |
| CHU de Limoges - Hôpital Dupuytren | Limoges | 87042 | France |
| Groupe Hospitalier Bichat Claude Bernard | Paris | 75018 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| Hôpitaux Universitaires de strasbourg - hôpital civil | Strasbourg | 67091 | France |
| Hadassah Ein Karem Hospital | Jerusalem | 9112001 | Israel |
| The Chaim Sheba Medical Center; Multiple Sclerosis Center | Ramat Gan | 5262100 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location | Chisinau | MD-2025 | Moldova |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Asan Medical Center. | Seoul | 5505 | South Korea |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided