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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723551
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date November 28, 2019
Actual Study Start Date  ICMJE February 20, 2019
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Event (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome [ Time Frame: Up to Week 24 ]
  • Change From Baseline in Number of Participants With Incidence of Laboratory Abnormalities at Week 24 [ Time Frame: Baseline, Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03723551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
Proportion of Participants With Clinical Response at Day 8, 28, 42, 84, 112 and 168 [ Time Frame: Day 8, 28, 42, 84, 112 and 168 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
Official Title  ICMJE 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
Brief Summary This is an open-label study to assess the safety and tolerability 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bone or Joint Infection
Intervention  ICMJE
  • Drug: Afabicin
    Afabicin will be given IV at a dose 160 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 240 mg BID for the remaining treatment duration.
  • Drug: SOC
    For oxacillin-/ methicillin-susceptible staphylococci, the recommended SOC for the comparator arm are: IV - cefazolin or vancomycin or linezolid or clindamycin and oral - linezolid or clindamycin. For oxacillin-/ methicillin-resistant staphylococci, the recommended SOC for the comparator arm are: IV - vancomycin or clindamycin or linezolid and oral - linezolid or clindamycin.
Study Arms  ICMJE
  • Experimental: Afabicin
    Participants will be administered with open label Afabicin intravenous (IV) at a dose of 160 milligram (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.
    Intervention: Drug: Afabicin
  • Active Comparator: Standard of Care (SOC)
    Participants will be administered with SOC in accordance with the approved regional labeling, without exceeding the maximum dosing schedule.
    Intervention: Drug: SOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 23, 2020
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of bone or joint infection which fulfills 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723551
Other Study ID Numbers  ICMJE Debio 1450-BJI-205
2017-002854-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Debiopharm International SA
Study Sponsor  ICMJE Debiopharm International SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Debiopharm International SA
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP