A Prospective, Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® in Bacterial Infection Treatment in Patients With Surgical Wounds
DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S. aureus and P. aeruginosa. The primary objective of the study is to demonstrate the safety of DUOFAG® and the clinical and microbiological change within 10 weeks after the start of treatment or until healing.
• Patients with surgical wound infection and/or dehiscence
• Wound infected by S. aureus and/or P. aeruginosa according to wound swab.
• Wound in the groin or any other skin fold as per Investigator's discretion.
• Signed Informed Consent Form, approved by the ethical committee and competent authority.
• The age between 18 and 75 years.
• Patients able and willing to comply with study procedures.
• There are no contraindications for planned concomitant medication.
• Persisting symptoms of bacterial infection \< 3 weeks since the surgery.
• Women of childbearing potential must take highly effective contraceptive measures since the study start and one month after the treatment administration at a minimum.