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 (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03723551

Collaborator

(none)

Enrollment

Locations

Arms

58.3

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an 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).

Condition or Disease	Intervention/Treatment	Phase
Bone or Joint Infection	Drug: Afabicin (Part A) Drug: Standard of Care Drug: Afabicin (Part B)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 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 :

Feb 20, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afabicin (Part A) Enrollment in Part A has been permanently halted.	Drug: Afabicin (Part A) 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) (Part A) Enrollment in Part A has been permanently halted.	Drug: Standard of Care Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Experimental: Afabicin (Part B)	Drug: Afabicin (Part B) Participants will be administered with open label afabicin intravenous (IV) at a dose of 55 milligrams (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 80 mg BID for the remaining treatment duration. In certain study conditions a higher dosing regimen of afabicin might be used: afabicin intravenous (IV) at a dose of 80 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 120 mg BID for the remaining treatment duration.
Active Comparator: Standard of Care (SOC) (Part B)	Drug: Standard of Care Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious Adverse Event (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome [Baseline up to Week 12]
Change From Baseline in Number of Participants With Incidence of Laboratory Abnormalities [Baseline up to Week 12]

Secondary Outcome Measures

Percentage of Participants With Clinical Response [Days 8, 28, 42, 4-weeks and 12-weeks post end of treatment (EOT - Up to 12 weeks), as applicable up to Day 168]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Health System CTSC Clinical Research Center	Sacramento	California	United States	95817
2	Midland Florida Clinical Research Center	DeLand	Florida	United States	32720
3	Augusta University	Augusta	Georgia	United States	30912
4	South Jersey Infectious Disease	Somers Point	New Jersey	United States	08244
5	Wake Forest University Baptist Medical Center	North Wilkesboro	North Carolina	United States	27157
6	Center for Traumatology and Orthopedics Co Ltd.	Chernivtsi		Ukraine	58023
7	Dnipropetrovsk Regional Clinical Hospital	Dnipropetrovs'k		Ukraine	49027
8	Ukrainian State Institute of Medical and Social Problems of Disability Ministry of Public Health of Ukraine	Dnipropetrovs'k		Ukraine	49027
9	Regional Clinical Hospital under Ivano-Frankivsk Regional Council	Ivano-Frankivs'k		Ukraine	76008
10	Kharkiv City Clinical Hospital #2	Kharkiv		Ukraine	61037
11	Kharkiv Regional Clinical Traumatology Hospital	Kharkiv		Ukraine	61176
12	Institute of Traumatology and Orthopedics	Kyiv		Ukraine	01601
13	Kyiv Regional Clinical Hospital	Kyiv		Ukraine	04107
14	Vinnytsya Regional Clinical Hospital	Vinnytsia		Ukraine	21028
15	Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa	Vynnyky		Ukraine	79495
16	City Hospital #9 under Zaporizhia City Council	Zaporizhia		Ukraine	69065

Sponsors and Collaborators

Debiopharm International SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Debiopharm International SA

ClinicalTrials.gov Identifier:

NCT03723551

Other Study ID Numbers:

Debio 1450-BJI-205
2017-002854-35

First Posted:

Oct 29, 2018

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Arthritis, Infectious

Study Results

No Results Posted as of Jun 23, 2022