Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

Overview

Sponsor-declared trial summary

Key facts

Sponsor

MB PHARMA s.r.o.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-02-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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.

Secondary objectives 2

1. To evaluate changes in the skin wound status during 6-week period after the commencement of IMP application or until the wound is completely healed.
2. To assess subject compliance with home administration of IMP.

Conditions and MedDRA coding

Complicated skin wounds (wounds healing per secundam via granulation tissue) - either as a complication of healing of acute wounds (infected surgical or traumatic wounds) or chronic wounds, in both cases infected with S. aureus and/or P. aeruginosa.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subject with acute wound (surgical site or traumatic wound) infection and/or subject with complicated wound (chronic wound or complication of acute wound) infection
2. A wound infected with S. aureus and/or P. aeruginosa as determined by a wound swab
3. Strain isolated from wound swab is susceptible to IMP (as assessed by local laboratory)
4. Subject aged 18 to 80 years
5. No contraindications to the planned medication
6. Subject has provided written Informed consent and is willing and able to comply with the trial requirements
7. 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

Exclusion criteria 11

1. Condition after organ or bone marrow transplantation
2. Wound infection with an epidemiologically serious bacterial strain other than S. aureus or P. aeruginosa
3. Malignancy treatment <1 year prior to the Baseline visit
4. Pregnant women or women planning to become pregnant during the clinical trial
5. Women who are breastfeeding
6. Hypersensitivity to the IMP or placebo component
7. Subject with acute or chronic renal failure requiring dialysis
8. Subject undergoing immunosuppressive therapy (excluding conventional doses of corticosteroids)
9. Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol
10. Subject is participating in another clinical trial evaluating a drug or medical device that has not completed evaluation of the primary endpoints
11. Subject has other comorbidities or pathologies that, in the opinion of the Investigator, preclude the subject from participating in the clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days)
2. Efficiency (1): presence of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application
3. Efficiency (2): number of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application

Secondary endpoints 5

1. Occurrence and frequency of all (local and systemic) adverse reactions during the treatment and follow-up phase with a suspected or confirmed relatedness to IMP administration
2. Change in mLUMT score during the treatment and follow-up phase
3. Time from the start of IMP administration to the point of bacterial infection eradication - negative swab for S. aureus and/or P. aeruginosa
4. Time from the start of IMP administration until complete wound healing (if this occurs during treatment or follow-up phase)
5. Evaluation of possible differences in efficacy in inpatient and outpatient settings

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

MB PHARMA s.r.o.

Sponsor organisation

MB PHARMA s.r.o.

Address

Rubesova 72/9, Vinohrady Vinohrady

City

Prague

Postcode

120 00

Country

Czechia

Scientific contact point

Organisation

MB PHARMA s.r.o.

Contact name

Dana Stverakova

Public contact point

Organisation

MB PHARMA s.r.o.

Contact name

Dana Stverakova

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications