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

DUO2022_01

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.

2023-10-27

2025-12-31

2025-12-31

Recruiting

Early phase I

52

Inclusion Criteria: * 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. Exclusion Criteria: * History of an organ or bone marrow transplantation. * Any autoimmune disease. * Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c \>60 mmol/mol (6%). * Systematic immunosuppressive therapy. * Malignancy treatment \<1 year before the Baseline visit. * COVID-19 infection \<3 months before the Baseline visit, any signs of post-COVID syndrome. * Pregnancy or planning to become pregnant during the study. * Breastfeeding. * Participation in another clinical study. * Hypersensitivity to the IMP or placebo.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}

2024-03-19