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Clinical trials

A ‘clinical trial’ is a research study in which people agree to test a potential new treatment to prevent or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine existing treatments.


Clinical trial of Debio 1450 in acute bacterial skin and skin structure infections.

Debiopharm International conducted a Phase II randomized, double-blind trial in male and female patients with clinically documented acute bacterial skin and skin structure infections (ABSSSI). The infection is due to a bacteria called staphylococcus aureus that is sensitive or resistant to methicillin, an antibiotic of the penicillin class.

The purpose of this Phase II trial was to a) evaluate if two different dose levels of Debio 1450 (afabicin) Definition afabicin is a new antibiotic investigational drug, benefiting from both oral and IV formulations. It is a highly potent, staphylococcus-selective antibiotic active on staphylococci resistant to antibiotics currently in clinical use including beta lactams, vancomycin, daptomycin or linezolid. afabicin completed a Phase II study in ABSSSI in October 2016. More info: – a new antibiotic drug with a unique mechanism of action and a narrow spectrum of activity – are safe and work against staphylococcus, and b) examine the way the drug enters and leaves the blood and tissues over time. Results are compared to standard antibiotic therapy administered in a separate group of patients.

The patients were divided into two groups, one group received a high dose level and the second a low dose level. In both groups, afabicin was first given by the intravenous route followed by afabicin oral capsules. In a third patient group, patients receive standard antibiotic therapy with vancomycin by the intravenous route and linezolid orally. In total, the treatment lasted between 7 and 10 days and patients receive between 14 and 20 doses.

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