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

Must not have

Participants who have medical conditions that increase the risk of QT prolongation

Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that can cause abnormal heart rhythms.

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I have an infection caused by bacteria other than staphylococcus in my joint, bone, or blood.

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I haven't had a heart attack, stroke, or serious heart rhythm problems in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (at least 1 dose) 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 (at least 1 dose) 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 (at least 1 dose) 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.

0 / 3Eligibility criteria met