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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

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ClinicalTrials.gov Identifier: NCT03723551
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

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).

Condition or disease Intervention/treatment Phase
Bone or Joint Infection Drug: Afabicin (Part A) Drug: Standard of Care Drug: Afabicin (Part B) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
Experimental: Afabicin (Part A)
Enrollment in Part A has been permanently halted.
Drug: Afabicin (Part A)
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.

Active Comparator: Standard of Care (SOC) (Part A)
Enrollment in Part A has been permanently halted.
Drug: Standard of Care
Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.

Experimental: Afabicin (Part B) Drug: Afabicin (Part B)
Participants will be administered with open label afabicin intravenous (IV) at a dose of 55 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 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.

Active Comparator: Standard of Care (SOC) (Part B) Drug: Standard of Care
Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Event (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome [ Time Frame: Baseline up to Week 12 ]
  2. Change From Baseline in Number of Participants With Incidence of Laboratory Abnormalities [ Time Frame: Baseline up to Week 12 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Clinical Response [ Time Frame: Days 8, 28, 42, 4-weeks and 12-weeks post end of treatment (EOT - Up to 12 weeks), as applicable up to Day 168 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723551


Contacts
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Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Debiopharm International SA
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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT03723551    
Other Study ID Numbers: Debio 1450-BJI-205
2017-002854-35 ( EudraCT Number )
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases