KAYVIRUS DSM 33474; KAYVIRUS DSM 33473; PBUNAVIRUS DSM 33593; concentration solution of KAYVIRUS DSM 33473, KAYVIRUS DSM 33474, and PBUNAVIRUS DSM 33593 for Complicated skin wounds (infected wounds) | Staphylococcus aureus wound infection | Pseudomonas aeruginosa wound infection

Inclusion criteria

• {"criterion_text":"- Subject with acute wound (surgical site or traumatic wound) infection and/or subject with complicated wound (chronic wound or complication of acute wound) infection\n- A wound infected with S. aureus and/or P. aeruginosa as determined by a wound swab\n- Strain isolated from wound swab is susceptible to IMP (as assessed by local laboratory)\n- Subject aged 18 to 80 years\n- No contraindications to the planned medication\n- Subject has provided written Informed consent and is willing and able to comply with the trial requirements\n- A man or woman who can no longer conceive a child (at menopause or after removal of the uterus and/or ovaries) or a woman who has a negative pregnancy test at the first visit and agrees to use an effective method of contraception"}

Exclusion criteria

• {"criterion_text":"- Condition after organ or bone marrow transplantation\n- Subject is participating in another clinical trial evaluating a drug or medical device that has not completed evaluation of the primary endpoints\n- Subject has other comorbidities or pathologies that, in the opinion of the Investigator, preclude the subject from participating in the clinical trial\n- Wound infection with an epidemiologically serious bacterial strain other than S. aureus or P. aeruginosa\n- Malignancy treatment <1 year prior to the Baseline visit\n- Pregnant women or women planning to become pregnant during the clinical trial\n- Women who are breastfeeding\n- Hypersensitivity to the IMP or placebo component\n- Subject with acute or chronic renal failure requiring dialysis\n- Subject undergoing immunosuppressive therapy (excluding conventional doses of corticosteroids)\n- Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol"}

Primary endpoints

• {"endpoint_text":"- Safety: frequency of all serious (local and systemic) adverse reactions and events (see description in the relevant chapter) suspected or confirmed to be related to IMP administration during the IMP administration phase (0-14 days)","definition_or_measurement_approach":"Frequency of serious local and systemic adverse reactions/events suspected or confirmed related to IMP during IMP administration phase (0-14 days); collected/reported per safety reporting procedures specified in protocol."}
• {"endpoint_text":"- Efficiency (1): presence of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application","definition_or_measurement_approach":"Presence/absence of S. aureus and/or P. aeruginosa on wound swab cultures during the period of IMP application (assessed by wound swab and stamp examination)."}
• {"endpoint_text":"- Efficiency (2): number of S. aureus and/or P. aeruginosa colonies on wound swabs over the period of IMP application","definition_or_measurement_approach":"Quantitative count of S. aureus and/or P. aeruginosa colonies on wound swab cultures during IMP application period (measured from wound swab/stamp examinations)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence and frequency of all (local and systemic) adverse reactions during the treatment and follow-up phase with a suspected or confirmed relatedness to IMP administration","definition_or_measurement_approach":"Collection and tabulation of all local and systemic adverse reactions during treatment and follow-up, with assessment of relatedness to IMP per protocol safety procedures."}
• {"endpoint_text":"- Change in mLUMT score during the treatment and follow-up phase","definition_or_measurement_approach":"Change from baseline in mLUMT score measured during treatment and follow-up; mLUMT measured per protocol-specified instrument and schedule."}
• {"endpoint_text":"- Time from the start of IMP administration to the point of bacterial infection eradication - negative swab for S. aureus and/or P. aeruginosa","definition_or_measurement_approach":"Time (days) from first IMP application to first documented negative wound swab for S. aureus and/or P. aeruginosa."}
• {"endpoint_text":"- Time from the start of IMP administration until complete wound healing (if this occurs during treatment or follow-up phase)","definition_or_measurement_approach":"Time (days) from first IMP application to complete wound healing as assessed per protocol-defined wound healing criteria."}
• {"endpoint_text":"- Evaluation of possible differences in efficacy in inpatient and outpatient settings","definition_or_measurement_approach":"Comparative analysis of efficacy outcomes between subjects treated as inpatients versus outpatients per protocol-defined subgroup analyses."}

Czechia

Earliest CTIS Part Ii Submission Date

28-11-2025

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

73

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

MB PHARMA s.r.o.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Czechia