Treatment of surgical site infections using DUOFAG® phage therapy
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
This study is testing a new phage therapy called DUOFAG® to see if it can help people with surgical site infections caused by certain bacteria.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | MB PHARMA s.r.o. Industry-sponsored |
| Locations | 1 site (Brno, Czech Republic) |
| Trial ID | NCT06319235 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of DUOFAG®, a phage cocktail targeting Staphylococcus aureus and Pseudomonas aeruginosa, in patients with surgical site infections. Participants will be randomly assigned to receive either the investigational product or a placebo twice daily for two weeks, alongside standard care. The study will assess clinical and microbiological outcomes over a 10-week period, monitoring for adverse events and changes in infection status. Two cohorts will be recruited, with the second cohort proceeding based on satisfactory safety and treatment effects observed in the first.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with surgical wound infections caused by Staphylococcus aureus or Pseudomonas aeruginosa.
Not a fit: Patients with a history of organ or bone marrow transplantation, autoimmune diseases, or those on immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients suffering from difficult-to-treat surgical site infections.
How similar studies have performed: While phage therapy is a novel approach, previous studies have shown promise in treating bacterial infections, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brno, Czech Republic
- St. Anne's University Hospital Brno — Brno, Czech Republic, Czechia (Recruiting)
Study contacts
- Principal investigator: Robert Staffa, prof. — St. Anne's University Hospital Brno
- Study coordinator: Dana Štveráková, Ph.D.
- Email: stverakova@mbph.cz
- Phone: +420 604 912 940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.