Trials / Unknown
UnknownNCT02116010
Evaluation of Phage Therapy for the Treatment of Escherichia Coli and Pseudomonas Aeruginosa Wound Infections in Burned Patients
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
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Phagenix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PHAGOBURN is a 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 bacteriophage cocktails GMP produced. This project is a European Research \& Development (R\&D) project funded by the European Commission under the 7th Framework Programme for Research and Development. This project is involving 7 clinical sites in EU.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E. coli Phages cocktail | Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection |
| DRUG | Standard of care : Silver Sulfadiazine | Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound |
| DRUG | P. Aeruginosa, Phages cocktail | Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-07-01
- First posted
- 2014-04-16
- Last updated
- 2015-07-24
Locations
5 sites across 3 countries: Belgium, France, Switzerland
Source: ClinicalTrials.gov record NCT02116010. Inclusion in this directory is not an endorsement.