Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-12 @ 10:52 AM
Study NCT ID:
NCT05614895
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2022-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentrations of RO7223280', 'timeFrame': 'Cohort 1-3: From Day 1 up to Day 3; Cohort 4: From Day 1 up to Day 5'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5'}, {'measure': 'Percentage of Participants Who Died Due to Any Cause', 'timeFrame': 'Cohort 1-3: From Day 1 up to Day 4; Cohort 4: From Day 1 up to Day 5'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment\n* Ongoing clinical syndrome meeting at least one of the following criteria:\n\n 1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge\n 2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning\n 3. 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.\n 4. 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.\n\nExclusion Criteria:\n\n* Ongoing documented catheter-related bacteraemia as the sole ongoing infection\n* Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion\n* Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary'}, 'identificationModule': {'nctId': 'NCT05614895', 'briefTitle': 'A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections', 'orgStudyIdInfo': {'id': 'BP43949'}, 'secondaryIdInfos': [{'id': '2022-000456-11', 'type': 'EUDRACT_NUMBER'}, {'id': 'ISRCTN21709018', 'type': 'REGISTRY', 'domain': 'ISRCTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', '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.', 'interventionNames': ['Drug: RO7223280']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', '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.', 'interventionNames': ['Drug: RO7223280']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.', 'interventionNames': ['Drug: RO7223280']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', '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.', 'interventionNames': ['Drug: RO7223280']}], 'interventions': [{'name': 'RO7223280', 'type': 'DRUG', 'description': 'Participants will receive RO7223280, 600 mg, IV infusion for 1 hour on Day 1.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'RO7223280', 'type': 'DRUG', 'description': 'Participants will receive RO7223280, 400 mg, IV infusion for 1 hour on Day 1.', 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Associates', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Physicians', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital; Royal Oak Pharmacy', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '27858-4353', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges - Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de strasbourg - hôpital civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '9112001', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Ein Karem Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '5262100', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center; Multiple Sclerosis Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': 'MD-2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '07441', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', '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/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}