Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bone or Joint Infection
• Intervention / Treatment: Drug: Afabicin; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Debiopharm International S.A; Phone Number: +41 21 321 01 11; Email: clinicaltrials@debiopharm.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1900
    • Recruiting
    • Italian Hospital of La Plata
  • Buenos Aires, Argentina
    • Not yet recruiting
    • Cemic
  • Buenos Aires, Argentina, B1900AVG
    • Recruiting
    • Medical Institute Platense SA
  • Cordoba, Argentina, X5000
    • Recruiting
    • Hospital Nuestra Senora de la Misericordia
  • Cordoba, Argentina, X5016KEH
    • Recruiting
    • Cordoba Private University Hospital
  • Mendoza, Argentina, 5500
    • Recruiting
    • Luis Carlos Lagomaggiore Hospital
  • Rosario, Argentina, S2000CVB
    • Recruiting
    • British Sanatorium SA,
  • San Miguel De Tucumán, Argentina, 4000
    • Recruiting
    • 9 of July Sanatorium
  • Villa Regina, Argentina, 8336
    • Recruiting
    • Central Clinic S.A.
• South Africa
  • Benoni, South Africa, 1500
    • Recruiting
    • Worthwhile Clinical Trials, Lakeview Hospital
  • Centurion, South Africa, 1692
    • Recruiting
    • Johese Clinical Research
  • Mthatha, South Africa, 5099
    • Recruiting
    • Nelson Mandela Academic Hospital Mthatha
  • Pretoria, South Africa, 0002
    • Recruiting
    • Clinical Research Unit, University of Pretoria
  • Pretoria, South Africa, 0157
    • Recruiting
    • Global Clinical Trials (Pty) Ltd
  • Tongaat, South Africa, 4400
    • Recruiting
    • Mediclinic Victoria
• Ukraine
  • Dnipropetrovs'k, Ukraine, 49027
    • Active, not recruiting
    • Dnipropetrovsk Regional Clinical Hospital
  • Ivano-Frankivs'k, Ukraine, 76008
    • Active, not recruiting
    • Regional Clinical Hospital under Ivano-Frankivsk Regional Council
  • Kharkiv, Ukraine, 61176
    • Active, not recruiting
    • Kharkiv Regional Clinical Traumatology Hospital
  • Kyiv, Ukraine, 04107
    • Active, not recruiting
    • Kyiv Regional Clinical Hospital
  • Kyiv, Ukraine, 01601
    • Active, not recruiting
    • Institute of Traumatology and Orthopedics
  • Vinnytsia, Ukraine, 21028
    • Active, not recruiting
    • Vinnytsya Regional Clinical Hospital
  • Vynnyky, Ukraine, 79495
    • Active, not recruiting
    • Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
  • Zaporizhia, Ukraine, 69065
    • Active, not recruiting
    • City Hospital #9 under Zaporizhia City Council
• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Midland Florida Clinical Research Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, d) Infection is not associated with a diabetic foot; 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.
• Life expectancy of less than 1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afabicin; In Part A, afabicin will be given intravenous (IV) at a dose 160 milligrams (mg) twice daily (BID) for a minimum of 1 day (2 doses) 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. In Part B, participants will be administered with open label afabicin IV at a dose of 55 mg BID for a minimum of 1 day (2 doses) 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 (2 doses) 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.	Drug: Afabicin; Administered intravenously and orally.
Active Comparator: Standard of Care (SOC) (Parts A and B); Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.	Drug: Standard of Care; Administered with SOC in accordance with local practice and applicable treatment guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities	Baseline up to Week 12 post- EOT

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants With Clinical Response	Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168

Collaborators and Investigators

• Sponsor: Debiopharm International SA

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious; Anti-Infective Agents; Anti-Bacterial Agents; Afabicin
• Other Study ID Numbers: Debio 1450-BJI-205; 2017-002854-35 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No