Evaluation of Phage Therapy for the Treatment of Escheric... | NCT02116010

Official Title

Phase I/II Clinical Trial Randomized, Multicentric, Open Label, Standard of Care (Silver Sulfadiazine) Controlled Aiming at Assessing Tolerance and Efficacy of Local Bacteriophage Treatment of Wound Infections Due to E. Coli or P. Aeruginosa in Burned Patients Using Pherecydes Pharma Anti-Escherichia Coli and Anti-Pseudomonas Aeruginosa Bacteriophages GMP Produced Cocktails . This Project is a European Research & Development (R&D) Project Funded by the European Commission Under the 7th Framework Programme for Research and Development Involving 7 Clinical Sites in EU.

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E. coli, Standard of care : Silver Sulfadiazine	Active Comparator	Burn wounds infected by E. coli treated with Standard of care : Silver Sulfadiazine	Drug: Standard of care : Silver Sulfadiazine
E. coli, Phages cocktail	Experimental	Burn wounds infected by E. coli treated with Pherecydes Pharma Phages cocktail	Drug: E. coli Phages cocktail
P. aeruginosa, Standard of care : Silver Sulfadiazine	Active Comparator	Burn wounds infected with P. aeruginosa treated with Standard of care : Silver Sulfadiazine	Drug: Standard of care : Silver Sulfadiazine
P. aeruginosa, Phages cocktail	Experimental	Burn wounds infected by P. aeruginosa treated treated with Pherecydes Pharma Phages cocktail	Drug: P. Aeruginosa, Phages cocktail

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E. coli Phages cocktail	Drug	Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection	E. coli, Phages cocktail

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time for bacteria reduction adjusted on antibiotic treatment	Time necessary for a persistent bacteria reduction of two modes or persistent bacteria eradication relative to D0 adjusted on antibiotic treatment (active on targeted strain) introduced between D1 to D7. Bacteria count performed on bacteria targeted by the phages cocktail collected from surface swab samples assessed by the microbiologist.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Assessment of tolerance of treatment	Adverse events frequencies will be assessed in each treatment arms. Phages therapy safety profile will be compared to safety profile of standard of care .	21 days
Incidence an delay of infection reduction with different bacterial species from the targets

Eligibility Module

Name	Role	Phone	Extension	Email
Patrick Jault, MD	Contact	+33 1 41 46 62 13		patrick.jault@santarm.fr
Christine Cotton	Contact	+335 61 00 13 55		christine.cotton@statitec.com

Name	Affiliation	Role
Patrick Jault, MD	Service de Santé des Armées, Hopital Percy (Clamart, France)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Militaire Reine Astrid	Not yet recruiting	Brussels		B-1120	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30292481	Derived	Jault P, Leclerc T, Jennes S, Pirnay JP, Que YA, Resch G, Rousseau AF, Ravat F, Carsin H, Le Floch R, Schaal JV, Soler C, Fevre C, Arnaud I, Bretaudeau L, Gabard J. Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial. Lancet Infect Dis. 2019 Jan;19(1):35-45. doi: 10.1016/S1473-3099(18)30482-1. Epub 2018 Oct 3.