Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
NCT ID: NCT06319235
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2023-10-27
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
NCT01888367
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
NCT04411199
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
NCT03633123
Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds
NCT01547325
Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia
NCT03163446
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In both cohorts, the Investigational Medicinal Product (IMP) or placebo (the randomization ratio will be 1:1) will be applied twice a day for two weeks or until the commencement of healing.
Patients will receive the standard of care during the whole study duration. No concomitant treatment is planned during the treatment period.
The Adverse Events will be recorded on basis of an open interview without soliciting questions, and clinical observation. In case of occurrence of an adverse event (AE) with moderate or severe intensity possibly related to IMP, the treatment will be stopped, and the AE will be followed up until resolution.
Adverse Event descriptions, their severity (mild, moderate, or severe), duration and their perceived relationship to the study medication (probable, possible, unlikely, not related, and not sure) will be recorded.
The mLUMT (modified Leg Ulcer Measurement Tool) total score and individual item scores change since the baseline visit will be recorded.
Time from 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 will be recorded.
Time from the start of the study treatment until the wound is closed/healed (as assessed by investigator) will be recorded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Investigational arm
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).
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.
Control arm
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MB PHARMA s.r.o.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Staffa, prof.
Role: PRINCIPAL_INVESTIGATOR
St. Anne's University Hospital Brno
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Anne's University Hospital Brno
Brno, Czech Republic, Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
MB PHARMA website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-002412-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DUO2022_01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.