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Afabicin for Bone or Joint Infection
Study Summary
This trial will compare the safety and effectiveness of Afabicin to standard care for treating bone or joint infections.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a condition that can cause abnormal heart rhythms.I am at high risk for liver injury.I have an infection caused by bacteria other than staphylococcus in my joint, bone, or blood.I haven't had a heart attack, stroke, or serious heart rhythm problems in the last 3 months.I have a bone or joint infection not caused by diabetes, treated early, and possibly involving soft tissue.
- Group 1: Afabicin
- Group 2: Standard of Care (SOC) (Parts A and B)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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