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TERMINATED
NCT03723551
PHASE2

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

Sponsor: Debiopharm International SA

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2019-02-20

Completion Date

2025-04-23

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Afabicin

Administered intravenously and orally.

DRUG

Cefazolin

Administered intravenously.

DRUG

Vancomycin

Administered intravenously.

DRUG

Linezolid

Administered intravenously and orally.

DRUG

Clindamycin

Administered intravenously and orally.

Locations (19)

Georgian Clinics JSC

Akhalts'ikhe, Georgia

West Georgia Medical Center LLC

Kutaisi, Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, Georgia

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC

Tbilisi, Georgia

Academician Vakhtang Bochorishvili Clinic LTD

Tbilisi, Georgia

Caucasus Medical Center LLC

Tbilisi, Georgia

Worthwhile Clinical Trials, Lakeview Hospital

Benoni, South Africa

Clinical Research Unit, University of Pretoria

Pretoria, South Africa

Global Clinical Trials (Pty) Ltd

Pretoria, South Africa

Dnipropetrovsk Regional Clinical Hospital

Dnipro, Ukraine

Regional Clinical Hospital under Ivano-Frankivsk Regional Council

Ivano-Frankivsk, Ukraine

Kharkiv Regional Clinical Traumatology Hospital

Kharkiv, Ukraine

Institute of Traumatology and Orthopedics

Kyiv, Ukraine

Kyiv Regional Clinical Hospital

Kyiv, Ukraine

Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)

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, Ukraine