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Trial record 8 of 19 for:    Infections | Oxacillin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723551
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : October 2, 2019
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 Drug: SOC Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : July 23, 2020
Estimated Study Completion Date : July 23, 2020

Arm Intervention/treatment
Experimental: Afabicin
Participants will be administered with open label Afabicin intravenous (IV) at a dose of 160 milligram (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 240 mg BID for the remaining treatment duration.
Drug: Afabicin
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)
Participants will be administered with SOC in accordance with the approved regional labeling, without exceeding the maximum dosing schedule.
Drug: SOC
For oxacillin-/ methicillin-susceptible staphylococci, the recommended SOC for the comparator arm are: IV - cefazolin or vancomycin or linezolid or clindamycin and oral - linezolid or clindamycin. For oxacillin-/ methicillin-resistant staphylococci, the recommended SOC for the comparator arm are: IV - vancomycin or clindamycin or linezolid and oral - linezolid or clindamycin.




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: Up to Week 24 ]
  2. Change From Baseline in Number of Participants With Incidence of Laboratory Abnormalities at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Proportion of Participants With Clinical Response at Day 8, 28, 42, 84, 112 and 168 [ Time Frame: Day 8, 28, 42, 84, 112 and 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


Locations
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United States, Florida
Midland Florida Clinical Research Center
DeLand, Florida, United States, 32720
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, New Jersey
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
Ukraine
Cherkasy Regional Hospital of Cherkasy Oblast Council
Cherkasy, Ukraine, 18009
Dnipropetrovsk Regional Clinical Hospital
Dnipropetrovs'k, Ukraine, 49027
Ukrainian State Institute of Medical and Social Problems of Disability Ministry of Public Health of Ukraine
Dnipropetrovs'k, Ukraine, 49027
Kharkiv City Clinical Hospital #2
Kharkiv, Ukraine, 61037
Institute of Traumatology and Orthopedics
Kyiv, Ukraine, 01601
Kyiv Regional Clinical Hospital
Kyiv, Ukraine, 04107
Sponsors and Collaborators
Debiopharm International SA

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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT03723551     History of Changes
Other Study ID Numbers: Debio 1450-BJI-205
2017-002854-35 ( EudraCT Number )
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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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