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

Decision date (initial)

2024-12-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518307-22-01

EudraCT number

2022-002412-23

ClinicalTrials.gov

NCT06319235

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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 objectives 1

1. To demonstrate the microbiological effect on the bacterial population in the wound.

Conditions and MedDRA coding

Surgical wound infection/dehiscence caused by S. aureus and/or P. aeruginosa colonization

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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.

Exclusion criteria 10

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. For Cohort 1: The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.
2. For pooled Cohorts 1 & 2: Time to commencement of healing. The commencement of healing is defined as the composite measure when both the following conditions must be true: the granulation process in the wound has started, as indicated by the score ≤ 2 in each of the 3 items A8 – A10 of the mLUMT scale, the S. aureus and/or P. aeruginosa infection has been eradicated, i.e., the swab sample is negative on both S. aureus and P. aeruginosa.

Secondary endpoints 3

1. Safety endpoints: The frequency of the following symptoms following the IMP application will be evaluated: • local reactions (local rash onset, local sensations, worsening of local inflammatory signs, discharge) • systemic reactions (vital signs reactions, fever, rash, arthralgia, gastrointestinal symptoms).
2. Microbiological endpoints: Change of the microbiological profile of the wound assessed by swab (maximum 8 assessment points).
3. Clinical efficacy endpoints: mLUMT total score change since Baseline; Time since the start of the study treatment until the bacterial infection eradication – i. e. the swab sample is negative on S. aureus and/or P. aeruginosa; Time since the start of the study treatment until the granulation process in the wound has started, as indicated by the score ≤ 2 in all 3 items A8 – A10 of the mLUMT scale; Time since the start of the study treatment until the wound is closed as assessed by Investigator.

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 · 1 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 7 files

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

Application history

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