Bacterial Infections, Pseudomonas Aeruginosa Infection, Staphylococcus Aureus Infection, Surgical Site Infection, Surgical Wound Infection
Conditions
Keywords
Phage Therapy, Staphylococcus aureus, Pseudomonas aeruginosa, Surgical site infection, Bacteriophage, Bacterial infections
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.
Detailed description
The study population will be recruited in two cohorts. The microbiological population of the wound will be evaluated to analyze the effect of the treatment. If the safety profile and treatment effect are going to be satisfactory, the recruitment will proceed with Cohort 2. 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.
Interventions
DRUGIMP
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.
DRUGPlacebo
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
MB PHARMA s.r.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint - Cohort 1 | 10 weeks (the maximum duration) | The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP. |
| Primary endpoint - pooled Cohorts 1 & 2 | 10 weeks (the maximum duration) | Time to commencement of healing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints (assessed in pooled Cohorts 1 & 2) | 10 weeks (the maximum duration) | The frequency of the following symptoms following the IMP application will be evaluated: local reactions, systemic reactions. |
| Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2) | 2 weeks (the maximum duration) | Change of the microbiological profile of the wound assessed by swab. |
| Clinical efficacy endpoints | 10 weeks (the maximum duration) | The mLUMT total score change since Baseline, time since the start of the study treatment until the bacterial infection eradication, time since the start of the study treatment until the granulation process in the wound has started, time since the start of the study treatment until the wound is closed as assessed by Investigator. |
Countries
Czechia
Contacts
Primary ContactDana Štveráková, Ph.D.
Backup ContactMonika Peichlová, Ing.
Outcome results
None listed