Clinical Trial comparing the treatment effect of DUOFAG(R) as compared to placebo in the treatment of bacterial infection in surgical wounds
- Conditions
- Bacterial infection with Staphylococcus aureus and/or Pseudomonas aeruginosa in the surgical wound.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2022-002412-23-CZ
- Lead Sponsor
- MB PHARMA s. r. o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 52
1.Patients with surgical wound infection and/or dehiscence
2.Wound infected by S. aureus and/or P. aeruginosa according to wound swab.
3.Wound in the groin or any other skin fold as per Investigator’s discretion.
4.Signed Informed Consent Form, approved by the EC and CA
5.The age between 18 and 75 years.
6.Patients able and willing to comply with study procedures.
7.There are no contraindications for planned concomitant medication.
8.Persisting symptoms of bacterial infection < 3 weeks since the surgery.
9.Women of childbearing potential must take highly effective contraceptive measures since the study start and one month after the treatment administration at a minimum.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1.History of an organ or bone marrow transplantation.
2.Any autoimmune disease.
3.Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c >60 mmol/mol (6%).
4.Systematic immunosuppressive therapy.
5.Malignancy treatment <1 year before the Baseline visit.
6.COVID-19 infection <3 months before the Baseline visit, any signs of post-COVID syndrome.
7.Pregnancy or planning to become pregnant during the study.
8.Breastfeeding.
9.Participation in another clinical study.
10.Hypersensitivity to the IMP or placebo.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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. ;Secondary Objective: Not Applicable;Primary end point(s): Time to commencement of healing.;Timepoint(s) of evaluation of this end point: Within 10 weeks after treatment start at maximum.
- Secondary Outcome Measures
Name Time Method