Phase
Condition
N/ATreatment
Standard of Care
Afabicin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Able to provide written informed consent and to comply with study procedures.
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) Participantshad received no more than 7 days of empiric antibiotics prior to initiatingtreatment with study drug unless the pathogen isolated was resistant to theadministered empiric antibiotics; and, c) Biofilm is not considered to be yetestablished and/or has been mechanically eradicated; and, d) Infection is notassociated with an ischiatic or a sacral osteomyelitis; and e) Infection can involveperiosteal or soft tissue.
Exclusion
Key Exclusion Criteria:
Presence of co-infection with non-staphylococcal bacteria at the affected joint orbone site, or in the blood.
Participants at an increased risk of developing liver injury.
Participants who have medical conditions that increase the risk of QT prolongation.
Medical history within the previous 3 months of: myocardial infarction, unstableangina pectoris, coronary artery or cerebral revascularization procedure or stroke,ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or anyother clinically relevant symptomatic ventricular arrhythmias.
Documented history of alcohol or drug abuse within the previous 12 months.
For patients with DFO:
Severe peripheral arterial disease (PAD) requiring revascularization; however,patients with peripheral artery disease are eligible for inclusion, providedthey have undergone successful revascularization or it has been deemedunnecessary by a vascular surgeon
Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
Patients with Charcot foot (suspected neuro-osteoarthropathy according toInvestigator's judgment).
Need for digital amputation.
- Life expectancy of less than 1 year.
Study Design
Connect with a study center
CEMIC
Buenos Aires,
ArgentinaSite Not Available
Italian Hospital of La Plata
Buenos Aires, B1900
ArgentinaSite Not Available
Medical Institute Platense SA
Buenos Aires, B1900AVG
ArgentinaSite Not Available
Cordoba Private University Hospital
Cordoba, X5016KEH
ArgentinaSite Not Available
Hospital Nuestra Senora de la Misericordia
Cordoba, X5000
ArgentinaSite Not Available
Luis Carlos Lagomaggiore Hospital
Mendoza, 5500
ArgentinaSite Not Available
British Sanatorium SA,
Rosario, S2000CVB
ArgentinaSite Not Available
9 of July Sanatorium
San Miguel De Tucumán, 4000
ArgentinaSite Not Available
Central Clinic S.A.
Villa Regina, 8336
ArgentinaSite Not Available
Georgian Clinics JSC
Akhaltsikhe, 0800
GeorgiaSite Not Available
West Georgia Medical Center LLC
Kutaisi, 4600
GeorgiaSite Not Available
Academician Vakhtang Bochorishvili Clinic LTD
Tbilisi, 0160
GeorgiaSite Not Available
Caucasus Medical Center LLC
Tbilisi, 0186
GeorgiaSite Not Available
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141
GeorgiaSite Not Available
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 0101
GeorgiaSite Not Available
Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC
Tbilisi, 0144
GeorgiaSite Not Available
Global Clinical Trials (Pty) Ltd
Arcadia, 0001
South AfricaSite Not Available
Worthwhile Clinical Trials, Lakeview Hospital
Benoni, 1500
South AfricaSite Not Available
JOHESE Clinical Research
Centurion, 1692
South AfricaSite Not Available
Walk-a-Mile Centre for Advanced Orthopaedics
Centurion, 1692
South AfricaSite Not Available
Nelson Mandela Academic Hospital Mthatha
Mthatha, 5099
South AfricaSite Not Available
Clinical Research Unit, University of Pretoria
Pretoria, 0002
South AfricaSite Not Available
Global Clinical Trials (Pty) Ltd
Pretoria, 0157
South AfricaSite Not Available
Steve Biko Academic Hospital
Pretoria, 0002
South AfricaSite Not Available
Mediclinic Victoria
Tongaat, 4400
South AfricaSite Not Available
Cherkasy Regional Hospital of Cherkasy Oblast Council
Cherkasy, 18009
UkraineSite Not Available
Center for Traumatology and Orthopedics Co Ltd.
Chernivtsi, 58023
UkraineSite Not Available
Dnipropetrovsk Regional Clinical Hospital
Dnipropetrovs'k, 49027
UkraineSite Not Available
Regional Clinical Hospital under Ivano-Frankivsk Regional Council
Ivano-Frankivs'k, 76008
UkraineSite Not Available
Kharkiv City Clinical Hospital #2
Kharkiv, 61037
UkraineSite Not Available
Kharkiv Regional Clinical Traumatology Hospital
Kharkiv, 61176
UkraineSite Not Available
Institute of Traumatology and Orthopedics
Kyiv, 01601
UkraineSite Not Available
Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
Kyiv,
UkraineSite Not Available
Kyiv Regional Clinical Hospital
Kyiv, 04107
UkraineSite Not Available
Vinnytsya Regional Clinical Hospital
Vinnytsia, 21028
UkraineSite Not Available
Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
Vynnyky, 79495
UkraineSite Not Available
City Hospital #9 under Zaporizhia City Council
Zaporizhia, 69065
UkraineSite Not Available
UC Davis Health System CTSC Clinical Research Center
Sacramento, California 95817
United StatesSite Not Available
Midland Florida Clinical Research Center
DeLand, Florida 32720
United StatesSite Not Available
Midway Immunology and Research Center
Fort Pierce, Florida 34982
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
South Jersey Infectious Disease
Somers Point, New Jersey 08244
United StatesSite Not Available
Sergievsky Center - Columbia University (CUMC)
New York, New York 10032
United StatesSite Not Available
Wake Forest University Baptist Medical Center
North Wilkesboro, North Carolina 27157
United StatesSite Not Available
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
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