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Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
EU CTIS ID: 2025-522752-45-00
What this study is testing
To demonstrate safety and efficiency of IMP – reduction of presence or to achieve complete eradication of S. aureus and/or P. aeruginosa during 14 days of IMP application, evaluated by the wound swab and stamp examination.
- Phase II and Phase III (Integrated)
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
- Subject with acute wound (surgical site or traumatic wound) infection and/or subject with complicated wound (chronic wound or complication of acute wound) infection
- A wound infected with S. aureus and/or P. aeruginosa as determined by a wound swab
- Strain isolated from wound swab is susceptible to IMP (as assessed by local laboratory)
- Subject aged 18 to 80 years
- No contraindications to the planned medication
- Subject has provided written Informed consent and is willing and able to comply with the trial requirements
You likely can't join if
- Condition after organ or bone marrow transplantation
- Subject is participating in another clinical trial evaluating a drug or medical device that has not completed evaluation of the primary endpoints
- Subject has other comorbidities or pathologies that, in the opinion of the Investigator, preclude the subject from participating in the clinical trial
- Wound infection with an epidemiologically serious bacterial strain other than S. aureus or P. aeruginosa
- Malignancy treatment <1 year prior to the Baseline visit
- Pregnant women or women planning to become pregnant during the clinical trial
See the full eligibility criteria
- Subject with acute wound (surgical site or traumatic wound) infection and/or subject with complicated wound (chronic wound or complication of acute wound) infection
- A wound infected with S. aureus and/or P. aeruginosa as determined by a wound swab
- Strain isolated from wound swab is susceptible to IMP (as assessed by local laboratory)
- Subject aged 18 to 80 years
- No contraindications to the planned medication
- Subject has provided written Informed consent and is willing and able to comply with the trial requirements
- A man or woman who can no longer conceive a child (at menopause or after removal of the uterus and/or ovaries) or a woman who has a negative pregnancy test at the first visit and agrees to use an effective method of contraception
- Condition after organ or bone marrow transplantation
- Subject is participating in another clinical trial evaluating a drug or medical device that has not completed evaluation of the primary endpoints
- Subject has other comorbidities or pathologies that, in the opinion of the Investigator, preclude the subject from participating in the clinical trial
- Wound infection with an epidemiologically serious bacterial strain other than S. aureus or P. aeruginosa
- Malignancy treatment <1 year prior to the Baseline visit
- Pregnant women or women planning to become pregnant during the clinical trial
- Women who are breastfeeding
- Hypersensitivity to the IMP or placebo component
- Subject with acute or chronic renal failure requiring dialysis
- Subject undergoing immunosuppressive therapy (excluding conventional doses of corticosteroids)
- Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol
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.