Surgical Site Infection Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Czechia | St. Anne's University Hospital Brno | Brno | Czech Republic |
Lead Sponsor | Collaborator |
---|---|
MB PHARMA s.r.o. |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary endpoint - Cohort 1 | The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP. | 10 weeks (the maximum duration) | |
Primary | Primary endpoint - pooled Cohorts 1 & 2 | Time to commencement of healing. | 10 weeks (the maximum duration) | |
Secondary | Safety endpoints (assessed in pooled Cohorts 1 & 2) | The frequency of the following symptoms following the IMP application will be evaluated: local reactions, systemic reactions. | 10 weeks (the maximum duration) | |
Secondary | Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2) | Change of the microbiological profile of the wound assessed by swab. | 2 weeks (the maximum duration) | |
Secondary | Clinical efficacy endpoints | The mLUMT total score change since Baseline, time since the start of the study treatment until the bacterial infection eradication, time since the start of the study treatment until the granulation process in the wound has started, time since the start of the study treatment until the wound is closed as assessed by Investigator. | 10 weeks (the maximum duration) |
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