Kayvirus DSM 33474; Kayvirus DSM 33473; Pbunavirus DSM 33593; concentration solution of these bacteriophages for Surgical wound infection|Surgical wound dehiscence

Inclusion criteria

• {"criterion_text":"- Patients with surgical wound infection and/or dehiscence\n- Wound infected by S. aureus and/or P. aeruginosa according to wound swab.\n- Wound in the groin or any other skin fold as per Investigator’s discretion.\n- Signed Informed Consent Form, approved by the EC and CA\n- The age between 18 and 75 years.\n- Patients able and willing to comply with study procedures.\n- There are no contraindications for planned concomitant medication.\n- Persisting symptoms of bacterial infection < 3 weeks since the surgery.\n- 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

• {"criterion_text":"- History of an organ or bone marrow transplantation.\n- Hypersensitivity to the IMP or placebo.\n- Any autoimmune disease\n- Uncompensated diabetes mellitus, confirmed by the concentration of HbA1c >60 mmol/mol (6%).\n- Systematic immunosuppressive therapy.\n- Malignancy treatment <1 year before the Baseline visit.\n- COVID-19 infection <3 months before the Baseline visit, any signs of post-COVID syndrome.\n- Pregnancy or planning to become pregnant during the study.\n- Breastfeeding.\n- Participation in another clinical study."}

Primary endpoints

• {"endpoint_text":"- For Cohort 1: The endpoint will be the frequency of all (local and systemic) reactions with suspected or confirmed relation to IMP.","definition_or_measurement_approach":"Frequency (count and incidence) of all local and systemic reactions judged to be suspected or confirmed related to the investigational medicinal product (IMP)."}
• {"endpoint_text":"- For pooled Cohorts 1 & 2: Time to commencement of healing. The commencement of healing is defined as the composite measure when both the following conditions must be true: the granulation process in the wound has started, as indicated by the score ≤ 2 in each of the 3 items A8 – A10 of the mLUMT scale, the S. aureus and/or P. aeruginosa infection has been eradicated, i.e., the swab sample is negative on both S. aureus and P. aeruginosa.","definition_or_measurement_approach":"Time-to-event measured from start of treatment to the composite definition of healing: (1) granulation process indicated by mLUMT items A8–A10 each ≤2, AND (2) eradication of S. aureus and/or P. aeruginosa (negative wound swab for both organisms)."}

Secondary endpoints

• {"endpoint_text":"- Safety endpoints: The frequency of the following symptoms following the IMP application will be evaluated: •\tlocal reactions (local rash onset, local sensations, worsening of local inflammatory signs, discharge) •\tsystemic reactions (vital signs reactions, fever, rash, arthralgia, gastrointestinal symptoms).","definition_or_measurement_approach":"Assessment of frequency/incidence of specified local and systemic adverse reactions following IMP application, including local rash onset, local sensations, worsening local inflammatory signs, discharge, and systemic signs (vital signs changes, fever, rash, arthralgia, GI symptoms)."}
• {"endpoint_text":"- Microbiological endpoints: Change of the microbiological profile of the wound assessed by swab (maximum 8 assessment points).","definition_or_measurement_approach":"Microbiological profiling via wound swabs at up to 8 time points to document changes in bacterial colonization and presence/absence of target pathogens."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Changes in mLUMT total score from baseline; time-to-eradication defined by negative swab for S. aureus and/or P. aeruginosa; time-to-granulation (mLUMT A8–A10 ≤2); time-to-wound closure as per investigator assessment."}

Czechia

Earliest CTIS Part Ii Submission Date

13-11-2024

Latest Decision Or Authorization Date

12-06-2025

Processing Time Days

211

Number Of Sites

1

Number Of Participants

52

Primary sponsor

Full Name

MB PHARMA s.r.o.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Czechia