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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03723551
Other study ID # Debio 1450-BJI-205
Secondary ID 2017-002854-35
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 20, 2019
Est. completion date December 2026

Study information

Verified date May 2024
Source Debiopharm International SA
Contact Debiopharm International S.A
Phone +41 21 321 01 11
Email clinicaltrials@debiopharm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 111
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) 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, and, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue. Key Exclusion Criteria: - Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone 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, 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. - Documented history of alcohol or drug abuse within the previous 12 months. - For patients with DFO: 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 2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue). 3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment). 4. Need for digital amputation. - Life expectancy of less than 1 year.

Study Design


Intervention

Drug:
Afabicin
Administered intravenously and orally.
Standard of Care
Administered with SOC in accordance with local practice and applicable treatment guidelines.

Locations

Country Name City State
Argentina CEMIC Buenos Aires
Argentina Italian Hospital of La Plata Buenos Aires
Argentina Medical Institute Platense SA Buenos Aires
Argentina Cordoba Private University Hospital Cordoba
Argentina Hospital Nuestra Senora de la Misericordia Cordoba
Argentina Luis Carlos Lagomaggiore Hospital Mendoza
Argentina British Sanatorium SA, Rosario
Argentina 9 of July Sanatorium San Miguel De Tucumán
Argentina Central Clinic S.A. Villa Regina
Georgia Georgian Clinics JSC Akhaltsikhe
Georgia West Georgia Medical Center LLC Kutaisi
Georgia Academician Vakhtang Bochorishvili Clinic LTD Tbilisi
Georgia Caucasus Medical Center LLC Tbilisi
Georgia LEPL The First University Clinic of Tbilisi State Medical University Tbilisi
Georgia Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC Tbilisi
Georgia Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC Tbilisi
South Africa Worthwhile Clinical Trials, Lakeview Hospital Benoni
South Africa JOHESE Clinical Research Centurion
South Africa Nelson Mandela Academic Hospital Mthatha Mthatha
South Africa Clinical Research Unit, University of Pretoria Pretoria
South Africa Global Clinical Trials (Pty) Ltd Pretoria
South Africa Mediclinic Victoria Tongaat
Ukraine Dnipropetrovsk Regional Clinical Hospital Dnipropetrovs'k
Ukraine Regional Clinical Hospital under Ivano-Frankivsk Regional Council Ivano-Frankivs'k
Ukraine Kharkiv Regional Clinical Traumatology Hospital Kharkiv
Ukraine Institute of Traumatology and Orthopedics Kyiv
Ukraine Kyiv Regional Clinical Hospital Kyiv
Ukraine Vinnytsya Regional Clinical Hospital Vinnytsia
Ukraine Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa Vynnyky
Ukraine City Hospital #9 under Zaporizhia City Council Zaporizhia
United States Augusta University Augusta Georgia
United States Midland Florida Clinical Research Center DeLand Florida
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Debiopharm International SA

Countries where clinical trial is conducted

United States,  Argentina,  Georgia,  South Africa,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome Baseline up to 12-weeks post- end of treatment (EOT)
Primary Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities Baseline up to Week 12 post- EOT
Secondary Proportion of Participants With Clinical Response Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168