Clinical trial NCT03723551: Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Bone or Joint Infection
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 an ischiatic or a sacral osteomyelitis; 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.
* For patients with DFO:

  1. Severe peripheral arterial disease (PAD) requiring revascularization; however, patients with peripheral artery disease are eligible for inclusion, provided they have undergone successful revascularization or it has been deemed unnecessary by a vascular surgeon
  2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
  3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
  4. Need for digital amputation.
* Life expectancy of less than 1 year.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome
timeFrame: Baseline up to 12-weeks post- end of treatment (EOT)
measure: Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities
timeFrame: Baseline up to Week 12 post- EOT
Secondary outcomes:
measure: Proportion of Participants With Clinical Response
timeFrame: Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168
Other outcomes:
Locations:
city: Akhaltsikhe
country: Georgia
facility: Georgian Clinics JSC
city: Kutaisi
country: Georgia
facility: West Georgia Medical Center LLC
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
city: Tbilisi
country: Georgia
facility: LEPL The First University Clinic of Tbilisi State Medical University
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC
city: Tbilisi
country: Georgia
facility: Academician Vakhtang Bochorishvili Clinic LTD
city: Tbilisi
country: Georgia
facility: Caucasus Medical Center LLC
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials, Lakeview Hospital
city: Pretoria
country: South Africa
facility: Clinical Research Unit, University of Pretoria
city: Pretoria
country: South Africa
facility: Global Clinical Trials (Pty) Ltd
city: Dnipropetrovs'k
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Regional Clinical Hospital under Ivano-Frankivsk Regional Council
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Traumatology Hospital
city: Kyiv
country: Ukraine
facility: Institute of Traumatology and Orthopedics
city: Kyiv
country: Ukraine
facility: Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
city: Vinnytsia
country: Ukraine
facility: Vinnytsya Regional Clinical Hospital
city: Vynnyky
country: Ukraine
facility: Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
city: Zaporizhia
country: Ukraine
facility: City Hospital #9 under Zaporizhia City Council
Study officials:
References: