In short
It is one component of DUOFAG, an investigational topical solution being studied for treating wounds infected with Staphylococcus aureus and/or Pseudomonas aeruginosa. Two clinical trials are currently authorised: a Phase 1/2 trial with 52 participants and a Phase 4 trial with 100 participants, both testing the product applied directly to wounds.
Key points
- DUOFAG is being tested in two clinical trials for infected wounds.
- The trials target wounds infected with S. aureus and/or P. aeruginosa.
- One trial is Phase 1/2 with 52 participants; the other is Phase 4 with 100 participants.
- The product is applied topically on the wound as a cutaneous solution.
- Both trials measure safety and reduction or eradication of bacteria.
What is KAYVIRUS DSM 33473?
and has no marketing authorisation in the product records, meaning it is an investigational substance. The therapeutic area covers bacterial infections and skin and connective tissue diseases.
How does KAYVIRUS DSM 33473 work?
This kills the bacterium. The trials are designed to show that DUOFAG can reduce the presence of or completely eradicate Staphylococcus aureus and/or Pseudomonas aeruginosa from infected wounds.
Which conditions is it used or studied for?
- Surgical wound infection or dehiscence caused by S. aureus and/or P. aeruginosa colonisation — studied in the Phase 1/2 trial.
- Complicated skin wounds healing by granulation tissue — including infected surgical or traumatic wounds and chronic wounds infected with S. aureus and/or P. aeruginosa, studied in the Phase 4 trial.
How is KAYVIRUS DSM 33473 given?
The product is a cutaneous solution applied topically on the wound. In the Phase 4 trial, the dose is reported as 50,000,000,000 plaque-forming units (PFU) of DUOFAG applied to the wound. The comparator arm in both trials is 0.9% sodium chloride solution applied topically.
What do the clinical trials show?
Two clinical trials are authorised. The Phase 1/2 trial (NCT06319235) enrolled 52 participants and focuses primarily on safety, measuring the frequency of all local and systemic reactions suspected or confirmed to be related to the investigational product. The Phase 4 trial (2025-522752-45-00) enrolled 100 participants and measures safety plus efficacy, defined as the presence and number of S. aureus and/or P. aeruginosa colonies on wound swabs during 14 days of application. The Phase 1/2 trial also measures time to commencement of healing, defined as granulation tissue starting in the wound and eradication of the infection.
Who can take part in these trials?
The trials are interventional studies. The Phase 1/2 trial includes participants with surgical wound infection or dehiscence caused by S. aureus and/or P. aeruginosa colonisation. The Phase 4 trial includes participants with complicated skin wounds healing by granulation tissue, either infected surgical or traumatic wounds or chronic wounds, all infected with S. aureus and/or P. aeruginosa.