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Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
EU CTIS ID: 2024-518307-22-01
What this study is testing
The primary objective of the study is to demonstrate the safety of the product and the clinical and microbiological change within 10 weeks after the start of treatment or until healing.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 EC and CA
- The age between 18 and 75 years.
- Patients able and willing to comply with study procedures.
You likely can't join if
- History of an organ or bone marrow transplantation.
- Hypersensitivity to the IMP or placebo.
- 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.
See the full eligibility 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 EC and CA
- 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.
- History of an organ or bone marrow transplantation.
- Hypersensitivity to the IMP or placebo.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.