ventilator associated pneumonia (VAP) caused by serotype O11 Pseudomonas aeruginosa MedDRA version: 9.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia
Conditions
Interventions
Product Name: KBPA-101 (AERUMAB 11)
Product Code: KBPA-101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: pacibacumab
CAS Number: 885053-97-4
Current Sponsor code: KBPA-101
Other desc
Sponsors
Kenta Biotech Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years of age 2. Female patients sterilised, hysterectomised, post-menopausal, or negative pregnancy test at screening evaluation 3. Patient mechanically ventilated for at least 48 hours and clinical diagnosis (including a new or progressive infiltrate) of ventilator associated pneumonia (VAP), including recurrent VAP, with modified clinical pulmonary infection score (CPIS) higher than 3 points 4. Greater of equal to 6x105 CFU/mL of P. aeruginosa in quantification of mini-BAL tested with Roche-PCR-kit,and confirmed diagnosis of P. aeruginosa serotype O11 VAP tested in mini-BAL with Kenta-PCR-Kit or microbiologically confirmed diagnosis of P. aeruginosa serotype O11 VAP tested in miniBAL or BAL with conventional microbiology (equal or greater to 1x104 CFU/mL) 5. Patient is expected to survive longer than 72 hours 6. Written informed consent provided by relatives or the designated trusted person Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of any investigational drug within 30 days preceding the first dose of AERUMAB 11, or planned use during the study and safety follow-up periods 2. Existence of any surgical or medical condition that might render the patient unduly susceptible to possible toxicity from the monoclonal antibody, including septic shock (defined as hypotension, i.e. a systolic blood pressure < 90 mmHg, or a MAP < 60 mmHg, or a reduction of 40 mmHg in the systolic blood pressure from baseline, despite adequate fluid resuscitation) with or without multiple organ dysfunction syndrome (MODS), and presence of clinically relevant disseminated intravascular coagulation (overt DIC, as defined by a score of 5 or more using the scoring system proposed by the Scientific Subcommittee on Disseminated Intravascular Coagulation (DIC) of the ISTH) 3. Patients with a known hereditary complement deficiency associated with systemic lupus erythematosus (SLE), paroxysmal nocturnal hemoglobinuria (PNH), hereditary angioedema (HAE), membranoproliferative glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections 4. Confirmed Human Immunodeficiency Virus (HIV) infection 5. Transplant patients and/or sSimultaneous treatment with systemic immuno-suppressive drugs (prednisone or prednisolone allowed) 6. Patients with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh B or C) or acute hepatitis 7. Administration of poly- or mono-immunoglobulins within the three months preceding the first dose of study drug or planned administration during the study period 8. Neutropenic patients (absolute neutrophil count < 1000 cells per microlitre)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, tolerability and repeated dose pharmacokinetics of three separate infusions of KBPA-101 every third day.;Secondary Objective: 1. To determine the most appropriate dosing schedule to maintain the trough plasma concentration of KBPA-101 above the supposed clinically and microbiologically effective level during the treatment period. 2. To determine the most appropriate dose and schedule of KBPA-101 for subsequent Phase II efficacy studies in pseudomonal VAP, as judged by the plasma concentration of KBPA-101. 3. To seek possible evidence of therapeutic efficacy of KBPA-101 given in addition to standard care for VAP including the most appropriate choice of antibiotics according to local bacterial prevalence. 4. To correlate apparent clinical benefit with plasma concentrations of KBPA-101. 5. To identify the most appropriate assessment methodology to be used in subsequent larger trials.;Primary end point(s): To assess the safety, tolerability and repeated dose pharmacokinetics of three separate infusions of KBPA-101 every third day. | — |
Countries
Belgium, France, Greece
Outcome results
None listed