Date: 2015-09-09
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Ministry of Defence (France) Pherecydes Pharma (France) Clean Cells (France)
Product: phage therapy
Action
mechanism: phage therapy. Sepsis is the major problem of large burn patients and a predominant cause of death. The burn wound pathology, combined to a global intensive use of antibiotics (ATB), put patients at high risk of suffering from multidrug resistant (MDR) infections, notably carried out by the Gram-negative bacteria species: Pseudomonas aeruginosa or Escherichia coli. But the last Gram- ATB is more than 20 years old and impeded by spread out exponential resistance. New ATB with genuine mode of action to target current resistant types are out of scope. In this context, MDR Gram- infections are becoming orphan pathologies without treatment. Fighting MDR in burn trauma is becoming an urgent medical need through innovation.
PHAGOBURN is focused on a highly promising alternative to ATB: phage therapy. Bacteriophages are viruses that specifically infect and kill bacteria during their replicative cycle. The main objective of the project is to assess the safety, effectiveness and pharmacodynamics of two therapeutic phage cocktails to treat either E. coli or P. aeruginosa burn wound infections. T
Disease: Escherichia coli and Pseudomonas aeruginosa skin infections in burn patients
Therapeutic area: Dermatological diseases - Infectious diseases
Country: France, Belgium, Switzerland
Trial
details: The PHAGOBURN study aims at evaluating phage therapy (therapeutic use of bacteriophages) to treat skin infections caused by Escherichia coli and Pseudomonas aeruginosa bacteria in burn patients. Phage therapy efficacy and safety will be evaluated through a phase I/II clinical study in accordance with Good Clinical and Manufacturing Practices (GCP and GMP). This clinical trial, to be carried out in France, Belgium and Switzerland within hospital units dedicated to burn patients’ care, is the first of its kind at world scale.
Phagoburn is coordinated by the Percy Military Hospital (France), a Service de Santé des Armées (SSA) Hospital within the French Ministry of Defence. It is being conducted in 11 major burns units in France, Switzerland and Belgium. Two other military hospitals are involved in the project – the Reine Astrid Hospital in Brussels (Belgium) and the Sainte-Anne Military Hospital in Toulon (France). Eight civilian hospitals are also taking part: the Liège teaching hospital (CHU) and the Grand-Hôpital of Charleroi-Loverval (Belgium), the Vaud CHU (Switzerland), the St. Joseph/St. Luc Hospital in Lyon, the Nantes and Bordeaux CHUs, the Metz-Thionville regional hospital and the Conception hospital in Marseille (France). Clean Cells, a French pharmaceutical company, carried out the bioproduction of the phages in line with current pharmaceutical good manufacturing practices (GMP). CRO Statitec (France), which is responsible for managing the trial data and statistical aspects, is also participating in the project. (NCT02116010)
Latest
news: * On September 9, 2015, Pherecydes Pharma, a biotechnology company specialized in the research and development of therapeutic lytic bacteriophages, announces the launch of the Phagoburn clinical trial. This randomized and monitored phase I/II single-blind trial aims to evaluate the tolerance and effectiveness of two anti-infection bacteriophage treatments in serious burn patients. The effect of the bacteriophages is compared to a reference treatment: silver sulfadiazine. This first international clinical study on phages will involve 220 patients spread across two arms: 110 patients for each of the two bacteriophages cocktails developed by Pherecydes Pharma. One of the products targets bacterial infections caused by Escherichia coli, the other targets infections caused by Pseudomonas aeruginosa. Infections involving these germs are often very severe. These species frequently and rapidly attain high levels of resistance to antibiotics. This can be fatal if therapy fails. The trial began in July 2015.Phagoburn is part of a European FP7 project. The study, launched in June 2013 for a period of three years, has received €3.85 million ($4.3 million) in European Union funding. * On June 1st, 2013, the first European clinical study on phage therapy to treat has been launched under the coordination of the French Ministry of Defence (Army Health Service – Percy Military Hospital) collaborating with Pherecydes Pharma and Clean Cells. The PHAGOBURN study aims at evaluating phage therapy (therapeutic use of bacteriophages) to treat skin infections caused by Escherichia coli and Pseudomonas aeruginosa bacteria in burn patients. PHAGOBURN has a total budget close to 5 million euros, with a European funding of over 3.8 million euros.
