Brussels, Belgium
#00289
Implements
#00394 Standardize matched bacteriophage therapy and quality-controlled manufacturing
Implementer
PhagoBurn consortium and participating European burn centres
Location
Description
PhagoBurn was a randomized, controlled phase 1/2 trial comparing a topical anti-Pseudomonas aeruginosa phage cocktail with standard care for infected burn wounds, conducted across multiple European burn units. Manufactured phage titres declined during the trial, resulting in participants receiving a much lower concentration than planned. Bacterial burden decreased more slowly in the phage arm than with standard care, and some isolates from treatment failures showed resistance to the low phage dose. This implementation failure does not establish that adequately matched and manufactured phage therapy is ineffective.
Metrics
2Lessons learned
- Phage potency and titre must be verified at each stage: manufacturing, storage, and point of administration — titre loss between production and delivery was the proximate cause of trial failure.
- Host-range matching and phage-resistance testing must be conducted prior to treatment when the phage cocktail has a narrow activity spectrum.
- A trial in which the delivered dose was substantially below the planned dose should be classified as an execution failure, not as evidence that the therapeutic mechanism is ineffective — trial design should include dose-verification checkpoints.