Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

NCT06319235 | Recruiting Phase 1

• 2 other identifiers: DUO2022_012022-002412-23
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S. aureus and P. aeruginosa. The primary objective of the study is to demonstrate the safety of DUOFAG® and the clinical and microbiological change within 10 weeks after the start of treatment or until healing.

Conditions

Surgical Site Infection; Staphylococcus Aureus Infection; Pseudomonas Aeruginosa Infection; Bacterial Infections; Surgical Wound Infection

Keywords

Phage Therapy; Staphylococcus aureus; Pseudomonas aeruginosa; Surgical site infection; Bacteriophage; Bacterial infections

Outcome Measures

Primary Outcomes (2)

• Primary endpoint - Cohort 1

  The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.

  10 weeks (the maximum duration)

• Primary endpoint - pooled Cohorts 1 & 2

  Time to commencement of healing.

  10 weeks (the maximum duration)

Secondary Outcomes (3)

• Safety endpoints (assessed in pooled Cohorts 1 & 2)

  10 weeks (the maximum duration)

• Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2)

  2 weeks (the maximum duration)

• Clinical efficacy endpoints

  10 weeks (the maximum duration)

Study Arms (2)

Investigational arm

EXPERIMENTAL

DUOFAG® (the investigational medicinal product - IMP) will be administered twice a day for two weeks. DUOFAG® will be sprayed on the surgical wound. The phage titers of each bacteriophage in DUOFAG® is ≥ 10 000 000 PFU/mL (PFU = plaque forming units).

Drug: IMP

Control arm

PLACEBO COMPARATOR

Placebo (physiological saline solution - 0.9% sodium chloride solution) will be administered twice a day for two weeks. Placebo will be sprayed on the surgical wound.

Drug: Placebo

Interventions

IMP DRUG

DUOFAG® is a phage cocktail (cutaneous liquid) manufactured by MB PHARMA s.r.o. and it contains bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa.

Also known as: DUOFAG®

Investigational arm

Placebo DRUG

0.9% Sodium Chloride Injection solution was manufactured by B. Braun Melsungen AG. Marketing authorization number assigned from the State Institute for drug control (Czech Republic): 76/847/92-B/C

Also known as: 0.9% Sodium Chloride Injection

Control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 ethical committee and competent authority.
• 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.

You may not qualify if:

• History of an organ or bone marrow transplantation.
• 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.
• Hypersensitivity to the IMP or placebo.

Sponsors & Collaborators

• MB PHARMA s.r.o.: lead

Study Sites (1)

St. Anne's University Hospital Brno

Brno, Czech Republic, 602 00, Czechia

RECRUITING

Related Links

• MB PHARMA website

MeSH Terms

Conditions

Surgical Wound Infection; Staphylococcal Infections; Pseudomonas Infections; Bacterial Infections

Interventions

Inosine Monophosphate; Sodium Chloride

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Robert Staffa, prof.

  St. Anne's University Hospital Brno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Štveráková, Ph.D.

CONTACT

+420 604 912 940; stverakova@mbph.cz

Monika Peichlová, Ing.

CONTACT

+420 777 487 400; peichlova@mbph.cz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: October 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)