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Antibiotic

Afabicin for Bone or Joint Infection

Phase 2
Recruiting
Research Sponsored by Debiopharm International SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 8, 28, 42, eot, 4-weeks and 12-weeks post- eot, as applicable up to day 168
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of Afabicin to standard care for treating bone or joint infections.

Who is the study for?
This trial is for people with bone or joint infections caused by Staphylococcus bacteria, who've had less than a week of antibiotics unless the bug was resistant. They must be able to follow study rules and not have diabetic foot-related infections, other bacterial co-infections, recent serious heart issues, drug/alcohol abuse history in the last year, short life expectancy or risk factors for liver injury or abnormal heart rhythm.Check my eligibility
What is being tested?
The study tests Afabicin's safety and effectiveness against bone/joint staph infections compared to standard treatments. It's randomized (participants are put into groups by chance) and open-label (everyone knows which treatment they're getting).See study design
What are the potential side effects?
Possible side effects aren't specified here but generally could include digestive problems, allergic reactions, liver issues especially if there's an increased risk mentioned in exclusion criteria, and potentially heart rhythm changes due to concerns about QT prolongation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 8, 28, 42, eot, 4-weeks and 12-weeks post- eot, as applicable up to day 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 8, 28, 42, eot, 4-weeks and 12-weeks post- eot, as applicable up to day 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome
Secondary outcome measures
Proportion of Participants With Clinical Response

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AfabicinExperimental Treatment1 Intervention
In Part A, afabicin will be given intravenous (IV) at a dose 160 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 240 mg BID for the remaining treatment duration. In Part B, participants will be administered with open label afabicin IV at a dose of 55 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 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.
Group II: Standard of Care (SOC) (Parts A and B)Active Control1 Intervention
Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.

Find a Location

Who is running the clinical trial?

Debiopharm International SALead Sponsor
49 Previous Clinical Trials
6,686 Total Patients Enrolled

Media Library

Afabicin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03723551 — Phase 2
Osteomyelitis Research Study Groups: Afabicin, Standard of Care (SOC) (Parts A and B)
Osteomyelitis Clinical Trial 2023: Afabicin Highlights & Side Effects. Trial Name: NCT03723551 — Phase 2
Afabicin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03723551 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Afabicin (Part B) been granted regulatory approval?

"Afabicin (Part B) has been assigned a score of 2, as it is currently in its second clinical trial phase. This suggests that while there are limited safety data, no efficacy data have yet been collected."

Answered by AI

Is this trial the maiden venture of its type?

"At the moment, Afabicin (Part B) is undergoing a single trial at 5 locations across 2 nations. Funded by Debiopharm International SA in 2019, this initial 96-person Phase 2 drug approval test has been followed up with 228 additional trials to date."

Answered by AI

Are there any precedent studies that incorporated Afabicin (Part B)?

"Afabicin (Part B) first entered clinical trials in 2019 at the Center for Traumatology and Orthopedics Co Ltd. To date, there have been 228 successful studies completed with one still actively recruiting patients out of DeLand, Florida."

Answered by AI

Could you provide an estimate of the number of healthcare facilities administering this trial?

"The Midland Florida Clinical Research Center in DeLand, FL; Wake Forest University Baptist Medical Center in North Wilkesboro, NC; and Augusta University in Augusta, GA are the primary sites of this study. An additional four medical facilities have been enlisted to participate as well."

Answered by AI

How many individuals are currently participating in this clinical experiment?

"For this trial, 96 individuals with specific inclusion criteria will be required. The sponsor is Debiopharm International SA, who are running the study from two primary locations: Midland Florida Clinical Research Center in DeLand and Wake Forest University Baptist Medical Center in North Wilkesboro."

Answered by AI

Does this research effort still have openings for participants?

"According to information available on clinicaltrials.gov, this medical study is actively recruiting participants. It was first advertised in February 2019 and edited most recently at the end of September 2022."

Answered by AI
~31 spots leftby Mar 2026