Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients

NCT02116010 | Unknown Phase 1 DMC

• 1 other identifier: PHAGOBURN
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 5

Brief Summary

The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.

Conditions

Wound Infection

Keywords

Wound Infection in burned patient

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Assessment of tolerance of treatment

  21 days

• Incidence an delay of infection reduction with different bacterial species from the targets

  7 days

• number of sites cured

  7 days

Study Arms (4)

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

E. coli Phages cocktail DRUG

Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection

E. coli, Phages cocktail

Standard of care : Silver Sulfadiazine DRUG

Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound

E. coli, Standard of care : Silver Sulfadiazine; P. aeruginosa, Standard of care : Silver Sulfadiazine

P. Aeruginosa, Phages cocktail DRUG

Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection

P. aeruginosa, Phages cocktail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman
• Adult Informed consent obtained from patient or next of kin
• In-hospital patient treated for burn wounds in a burn unit
• Burn wound (grafted or not) or graft harvesting area, presenting local signs of infection defined by SFETB criteria:
• A local or loco-regional inflammatory reaction;
• And/or an adverse and unexpected local evolution;
• And/or regarding burn wounds: presence of pus, fast spontaneous debridement and separation, occurrence of blackish spots (necrosis or haemorrhage), unexplained conversion from a superficial lesion to a deep one (\> 48th hour);
• And/or regarding graft donor sites: presence of pus, unexplained delay in epidermisation, bedsore;
• And/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft.
• Burn wounds with a microbiologically documented infection, as defined by positive surface swab, due to Escherichia coli or Pseudomonas aeruginosa whatever their resistance profile
• Treated by povidone-iodine

You may not qualify if:

• Pregnant or breastfeeding woman
• Intercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy
• Patient considered as part of a vulnerable population
• Patient for whom treatment limitation or withdrawal during study period is considered
• Allergy to Silver Sulfadiazine

Sponsors & Collaborators

• Phaxiam Therapeutics: lead

Study Sites (5)

Hopital Militaire Reine Astrid

Brussels, B-1120, Belgium

NOT YET RECRUITING

CHU Sart-Tilman

Liège, Belgium

NOT YET RECRUITING

Hôpital d'instruction des armées Percy

Clamart, 92141, France

RECRUITING

Centre hospitalier ST Joseph et St Luc

Lyon, F-69365, France

NOT YET RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 30292481 DERIVED

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Patrick Jault, MD

  Service de Santé des Armées, Hopital Percy (Clamart, France)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 16, 2014
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

BE (2); FR (2); CH (1)