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NCT03723551

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

Terminated Phase 2 Last updated 1 December 2025
What this trial tests

Phase 2 trial testing Afabicin in Bone or Joint Infection in 67 participants. Terminated before completion.

Timeline
20 February 2019
Primary endpoint
23 April 2025
23 April 2025

Quick facts

Lead sponsorDebiopharm International SA
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment67
Start date20 February 2019
Primary completion23 April 2025
Estimated completion23 April 2025
Sites19 locations across Georgia, South Africa, Ukraine

Drugs / interventions tested

Conditions studied

Sponsor

Debiopharm International SA — full company profile →

Who can join

18 and older, any sex, with Bone or Joint Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. ESKAPE pathogens: antimicrobial resistance, epidemiology, clinical impact and therapeutics.
    Miller WR, Arias CA. · · 2024 · cited 481× · PMID 38831030 · DOI 10.1038/s41579-024-01054-w
  2. Antibiotics in the clinical pipeline in October 2019.
    Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
  3. Antibiotics in the clinical pipeline as of December 2022.
    Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
  4. A Review of Antibacterial Candidates with New Modes of Action.
    Butler MS, Vollmer W, Goodall ECA, Capon RJ, et al · · 2024 · cited 49× · PMID 39018341 · DOI 10.1021/acsinfecdis.4c00218
  5. A Review of Fatty Acid Biosynthesis Enzyme Inhibitors as Promising Antimicrobial Drugs.
    Bibens L, Becker JP, Dassonville-Klimpt A, Sonnet P. · · 2023 · cited 32× · PMID 36986522 · DOI 10.3390/ph16030425
  6. Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
    Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191
  7. Addressing urgent priorities in antibiotic development: insights from WHO 2023 antibacterial clinical pipeline analyses.
    Melchiorri D, Rocke T, Alm RA, Cameron AM, et al · · 2025 · cited 18× · PMID 39454608 · DOI 10.1016/j.lanmic.2024.100992
  8. Novel drug candidates against antibiotic-resistant microorganisms: A review.
    Lim JS, Chai YY, Ser WX, Haeren AV, et al · · 2024 · cited 14× · PMID 38234674 · DOI 10.22038/ijbms.2023.71672.15593

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