PHAGOBURN trial: primary endpoint evaluation in phage therapy
PHAGOBURN is a Phase I/II randomized clinical trial assessing the efficacy and safety of two phage cocktails targeting E. coli or P. aeruginosa infections in third degree burn wounds, in comparison to silver sulfadiazine standard of care. This is a multi-centric study involving 11 different burn wards located in France, Belgium and Switzerland, i.e. i) France: Clamart-Percy2 (Principal investigator), Lyon-St. Joseph/St Luc3, CHU Nantes8, CHU Bordeaux15, Toulon-Sainte Anne13, Marseille-APHM16, and Metz-Mercy14 ; ii) Switzerland: Lausanne-CHUV4; iii) Belgium: Brussels-Queen Astrid military hospital5 , Grand Charleroi9, CHU Liege7.
The whole treatment and follow up lasts for 21 days on hospitalized patients in intensive care units. Each treatment is applied during 7 consecutive days, on daily changed alginate compresses (Algosteril™ – Les Laboratoires Brothier, France). The primary endpoint monitors the time to reduce the targeted bacterial species from wound burn daily swabs by two quadrants. It is carried out by hospital medical laboratories on D0 to D7 after inclusion and on D14.
This semi-quantitative microbiological procedure is compared to an independent and blind quantitative numeration of the targeted bacterial species at Pherecydes Pharma. In addition, the quantity of active phages from the swabs, is also numbered in line with bacterial numeration. Furthermore, the in vitro response of the patient infectious strain is daily checked during 7 to 14 days of treatment to evaluate the risk of resistance emergence.
The choice of the primary endpoint to evaluate phage therapy is discussed, in comparison to other primary criterion commonly used (mostly in the past) for evaluating chemical antibiotic efficacy. The strategy to maintain a blind evaluation of the primary endpoint, without jeopardizing the clinical outcome and the physician judgement about the patient treatment is weighted under the light of the PHAGOBURN trial progress.
PHAGOBURN is a private-public European consortium partially funded by FP7 Health Programme from the European Commission (€3.85M grant).
The whole treatment and follow up lasts for 21 days on hospitalized patients in intensive care units. Each treatment is applied during 7 consecutive days, on daily changed alginate compresses (Algosteril™ – Les Laboratoires Brothier, France). The primary endpoint monitors the time to reduce the targeted bacterial species from wound burn daily swabs by two quadrants. It is carried out by hospital medical laboratories on D0 to D7 after inclusion and on D14.
This semi-quantitative microbiological procedure is compared to an independent and blind quantitative numeration of the targeted bacterial species at Pherecydes Pharma. In addition, the quantity of active phages from the swabs, is also numbered in line with bacterial numeration. Furthermore, the in vitro response of the patient infectious strain is daily checked during 7 to 14 days of treatment to evaluate the risk of resistance emergence.
The choice of the primary endpoint to evaluate phage therapy is discussed, in comparison to other primary criterion commonly used (mostly in the past) for evaluating chemical antibiotic efficacy. The strategy to maintain a blind evaluation of the primary endpoint, without jeopardizing the clinical outcome and the physician judgement about the patient treatment is weighted under the light of the PHAGOBURN trial progress.
PHAGOBURN is a private-public European consortium partially funded by FP7 Health Programme from the European Commission (€3.85M grant).
Reference:
Phage Therapy I-T10-IvT-02
Session:
Phage Therapy 1: updates on treating human bacterial pathogens
Presenters:
Jerome Gabard
Session:
Phage Therapy 1: Updates on treating human microbial pathogens
Presentation type:
Invited talk - 25 min
Room:
Main Auditorium
Chair/s:
Catherine Rees
Date:
Thursday, 21 July 2016
Time:
09:00 - 09:25