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Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

NCT06319235 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-03-19

No results posted yet for this study

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

Interventions

DRUG

IMP

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • MB PHARMA s.r.o.

    lead INDUSTRY

Principal Investigators

  • Robert Staffa, prof. · St. Anne's University Hospital Brno

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319235 on ClinicalTrials.gov