Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT03723551
Status:
TERMINATED
Last Update Posted:
2025-12-01
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000657127', 'term': 'afabicin'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'This trial was concluded for strategic reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome', 'timeFrame': 'Baseline up to 12-weeks post- end of treatment (EOT)'}, {'measure': 'Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities', 'timeFrame': 'Baseline up to Week 12 post- EOT'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Clinical Response', 'timeFrame': 'Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone or Joint Infection']}, 'descriptionModule': {'briefSummary': 'This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus \\[both methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)\\] and/or coagulase-negative staphylococci (CoNS) and to compare it to standard of care (SOC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Able to provide written informed consent and to comply with study procedures.\n* Diagnosis of bone or joint infection which fulfils the following conditions: a) Infection is due to S. aureus (MSSA or MRSA) and/or CoNS only; and, b) Participants had received no more than 7 days of empiric antibiotics prior to initiating treatment with study drug unless the pathogen isolated was resistant to the administered empiric antibiotics; and, c) Biofilm is not considered to be yet established and/or has been mechanically eradicated; and, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue.\n\nKey Exclusion Criteria:\n\n* Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood.\n* Participants at an increased risk of developing liver injury.\n* Participants who have medical conditions that increase the risk of QT prolongation.\n* Medical history within the previous 3 months of: myocardial infarction, unstable angina pectoris, coronary artery or cerebral revascularization procedure or stroke, ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any other clinically relevant symptomatic ventricular arrhythmias.\n* Documented history of alcohol or drug abuse within the previous 12 months.\n* For patients with DFO:\n\n 1. Severe peripheral arterial disease (PAD) requiring revascularization; however, patients with peripheral artery disease are eligible for inclusion, provided they have undergone successful revascularization or it has been deemed unnecessary by a vascular surgeon\n 2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).\n 3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).\n 4. Need for digital amputation.\n* Life expectancy of less than 1 year."}, 'identificationModule': {'nctId': 'NCT03723551', 'briefTitle': 'Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus', 'orgStudyIdInfo': {'id': 'Debio 1450-BJI-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afabicin', 'description': 'In Part A, afabicin will be given intravenous (IV) at a dose 160 milligrams (mg) twice daily (BID) for a minimum of 1 day (at least 1 dose) and up to a maximum of 14 days (2 weeks), followed by a switch to oral Afabicin at a dose of 240 mg BID for the remaining treatment duration.\n\nIn Part B, participants will be administered with open label afabicin IV at a dose of 55 mg BID for a minimum of 1 day (at least 1 dose) and up to a maximum of 14 days (2 weeks) followed by a switch to oral afabicin at a dose of 80 mg BID for the remaining treatment duration. In certain study conditions a higher dosing regimen of afabicin might be used: afabicin intravenous (IV) at a dose of 80 mg BID for a minimum of 1 day (at least 1 dose) and up to a maximum of 14 days (2 weeks) followed by a switch to oral afabicin at a dose of 120 mg BID for the remaining treatment duration.', 'interventionNames': ['Drug: Afabicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC) (Parts A and B)', 'description': 'Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.', 'interventionNames': ['Drug: Standard of Care']}], 'interventions': [{'name': 'Afabicin', 'type': 'DRUG', 'description': 'Administered intravenously and orally.', 'armGroupLabels': ['Afabicin']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Administered with SOC in accordance with local practice and applicable treatment guidelines.', 'armGroupLabels': ['Standard of Care (SOC) (Parts A and B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0800', 'city': "Akhalts'ikhe", 'country': 'Georgia', 'facility': 'Georgian Clinics JSC', 'geoPoint': {'lat': 41.63952, 'lon': 42.98604}}, {'zip': '4600', 'city': 'Kutaisi', 'country': 'Georgia', 'facility': 'West Georgia Medical Center LLC', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'zip': '0101', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0141', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LEPL The First University Clinic of Tbilisi State Medical University', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0144', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Academician Vakhtang Bochorishvili Clinic LTD', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Caucasus Medical Center LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '1500', 'city': 'Benoni', 'country': 'South Africa', 'facility': 'Worthwhile Clinical Trials, Lakeview Hospital', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '0002', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Clinical Research Unit, University of Pretoria', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0157', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Global Clinical Trials (Pty) Ltd', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '49027', 'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Dnipropetrovsk Regional Clinical Hospital', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Regional Clinical Hospital under Ivano-Frankivsk Regional Council', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61176', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Kharkiv Regional Clinical Traumatology Hospital', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '01601', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Institute of Traumatology and Orthopedics', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04107', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv Regional Clinical Hospital', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '21028', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Vinnytsya Regional Clinical Hospital', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '79495', 'city': 'Vynnyky', 'country': 'Ukraine', 'facility': 'Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa', 'geoPoint': {'lat': 49.81672, 'lon': 24.14417}}, {'zip': '69065', 'city': 'Zaporizhia', 'country': 'Ukraine', 'facility': 'City Hospital #9 under Zaporizhia City Council'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}