Surgical Site InfectionPhase 1/2NCT06319235
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
A Phase 1/2 study testing IMP in people with Surgical Site Infection and Staphylococcus Aureus Infection, run by MB PHARMA s.r.o. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Site Infection, Staphylococcus Aureus Infection, Pseudomonas Aeruginosa Infection
- What is being tested?
- IMP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Oct 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Pregnancy or planning to become pregnant during the study.
- Breastfeeding.
- Participation in another clinical study.
- Hypersensitivity to the IMP or placebo.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
St. Anne's University Hospital Brno
Brno, Czech Republic, 602 00
Dominik Maduda, MUDr., +420 543 182 432, dominik.maduda@fnusa.cz
Kateřina Bílá, MUDr., +420 543 182 451, katerina.bila@fnusa.cz
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® in Bacterial Infection Treatment in Patients With Surgical Wounds
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.
Read the 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.
- Conditions
- Surgical Site Infection, Staphylococcus Aureus Infection, Pseudomonas Aeruginosa Infection, Bacterial Infections, Surgical Wound Infection
- Being tested
- IMP, Placebo
- Keywords
- Phage Therapy, Staphylococcus aureus, Pseudomonas aeruginosa, Surgical site infection, Bacteriophage, Bacterial infections
- Medical subject headings
- Surgical Wound Infection, Staphylococcal Infections, Pseudomonas Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPDrug
Also called DUOFAG®
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.
PlaceboDrug
Also called 0.9% Sodium Chloride Injection
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint - Cohort 1
The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.
Measured: 10 weeks (the maximum duration)
Primary endpoint - pooled Cohorts 1 & 2
Time to commencement of healing.
Measured: 10 weeks (the maximum duration)
Secondary outcomes (3)
Safety endpoints (assessed in pooled Cohorts 1 & 2)
The frequency of the following symptoms following the IMP application will be evaluated: local reactions, systemic reactions.
Measured: 10 weeks (the maximum duration)
Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2)
Change of the microbiological profile of the wound assessed by swab.
Measured: 2 weeks (the maximum duration)
Clinical efficacy endpoints
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.
Measured: 10 weeks (the maximum duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start27 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MB PHARMA s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Staffa, prof., Principal investigator, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319235
- Sponsor's protocol ID
- DUO2022_01
- Other IDs
- 2022-002412-23
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled Phase I/IIa Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® in Bacterial Infection Treatment in Patients With Surgical Wounds
- ClinicalTrials.gov ID
- NCT06319235
- Acronym / sponsor ID
- DUO2022_01
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- MB PHARMA s.r.o.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Drug: IMPDUOFAG® (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). |
| Control arm | Placebo comparator | Drug: PlaceboPlacebo (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPAlso: DUOFAG®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 | Investigational arm |
| PlaceboAlso: 0.9% Sodium Chloride Injection0.9% 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 | Drug | Control arm |
Primary outcome
Primary endpoint - Cohort 1
Time frame: 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
Time frame: 10 weeks (the maximum duration)
Time to commencement of healing.
3 secondary outcomes
Safety endpoints (assessed in pooled Cohorts 1 & 2)
Time frame: 10 weeks (the maximum duration)
Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2)
Time frame: 2 weeks (the maximum duration)
Clinical efficacy endpoints
Time frame: 10 weeks (the maximum duration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- MB PHARMA websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Staffa, prof. principal investigator
St. Anne's University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMP in people with Surgical Site Infection and Staphylococcus Aureus Infection, run by MB PHARMA s.r.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Štveráková, Ph.D. (+420 604 912 940, stverakova@mbph.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint - Cohort 1 (time frame: 10 weeks (the maximum duration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.