RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2019-02-20
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03723551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide written informed consent and to comply with study procedures.
  2. * 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.
  1. * Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood.
  2. * Participants at an increased risk of developing liver injury.
  3. * Participants who have medical conditions that increase the risk of QT prolongation.
  4. * 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.
  5. * Documented history of alcohol or drug abuse within the previous 12 months.
  6. * For patients with DFO:
  7. 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
  8. 2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
  9. 3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
  10. 4. Need for digital amputation.
  11. * Life expectancy of less than 1 year.

Contacts and Locations

Study Contact

Debiopharm International S.A
CONTACT
+41 21 321 01 11
clinicaltrials@debiopharm.com

Study Locations (Sites)

Midland Florida Clinical Research Center
DeLand, Florida, 32720
United States
Augusta University
Augusta, Georgia, 30912
United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Debiopharm International SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-20
Study Completion Date2026-12

Study Record Updates

Study Start Date2019-02-20
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Bone or Joint Infection