Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

Launched by MB PHARMA S.R.O. · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DUOFAG®, which is a mixture of viruses known as bacteriophages that specifically target certain harmful bacteria, including Staphylococcus aureus and Pseudomonas aeruginosa. These bacteria can cause infections in surgical wounds. The main goal of the trial is to see if DUOFAG® is safe and to observe how well it helps patients recover from these infections over a period of 10 weeks or until their wounds heal.

To participate, individuals need to be between 18 and 75 years old and have a surgical wound infection caused by the bacteria mentioned above. They must also be able to follow the study procedures and provide consent to take part in the trial. Participants will receive treatment and will be monitored for safety and effectiveness. It's important to note that certain health conditions, such as autoimmune diseases or recent cancer treatment, may exclude someone from joining the study. This trial is currently looking for volunteers, and it could be a valuable opportunity for those affected by serious surgical infections.

Gender

ALL

Eligibility criteria

• 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.