E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bacterial infection with Staphylococcus aureus and/or Pseudomonas aeruginosa in the surgical wound. |
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E.1.1.1 | Medical condition in easily understood language |
Bacterial infection with Staphylococcus aureus and/or Pseudomonas aeruginosa in the surgical wound. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to demonstrate the safety of the product and the clinical and microbiological change within 10 weeks after the start of treatment or until healing. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with surgical wound infection and/or dehiscence 2. Wound infected by S. aureus and/or P. aeruginosa according to wound swab. 3. Wound in the groin or any other skin fold as per Investigator’s discretion. 4. Signed Informed Consent Form, approved by the EC and CA 5. The age between 18 and 75 years. 6. Patients able and willing to comply with study procedures. 7. There are no contraindications for planned concomitant medication. 8. Persisting symptoms of bacterial infection < 3 weeks since the surgery. 9. Women of childbearing potential must take highly effective contraceptive measures since the study start and one month after the treatment administration at a minimum.
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E.4 | Principal exclusion criteria |
1. History of an organ or bone marrow transplantation. 2. Any autoimmune disease. 3. Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c >60 mmol/mol (6%). 4. Systematic immunosuppressive therapy. 5. Malignancy treatment <1 year before the Baseline visit. 6. COVID-19 infection <3 months before the Baseline visit, any signs of post-COVID syndrome. 7. Pregnancy or planning to become pregnant during the study. 8. Breastfeeding. 9. Participation in another clinical study. 10. Hypersensitivity to the IMP or placebo.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to commencement of healing. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 10 weeks after treatment start at maximum. |
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E.5.2 | Secondary end point(s) |
The frequency of the following symptoms following the IMP application will be evaluated: • local reactions (local rash onset, local sensations, worsening of local inflammatory signs, discharge) • systemic reactions (vital signs reactions, fever, rash, arthralgia, gastrointestinal symptoms)
Microbiological endpoints: Change of the microbiological profile of the wound assessed by swab (maximum 8 assessment points during the treatment period).
Clinical efficacy endpoints: • mLUMT total score change since Baseline • Time since 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 • Time since the start of the study treatment until the granulation process in the wound has started, as indicated by the score ≤ 2 in all 3 items A8 – A10 of the mLUMT scale. • Time since the start of the study treatment until the wound is closed as assessed by Investigator.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoints will be evaluated in 10 weeks after treatment start at maximum. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Study will be double blind. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |