A Randomized, double-blind, placebo-controlled pilot study of KB001 in mechanically-ventilated patients colonized with pseudomonas aeruginosa

INTERVENTION: Product Name: KB001 Product Code: KB001 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: KB001 Other descriptive name: PEgylated Recombinant Human Anti‐Pseudomonas aeruginosa PCrV Fab1 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 4.2‐5.8 Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Patients with Pseudomonas aeruginosa Ventilator‐Associated Pulmonary Infection ; MedDRA version: 9.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia PRIMARY OUTCOME: Main Objective: To evaluate the safety and tolerability of a single dose of KB001 at 3mg/kg and 10mg/kg in pulmonary Pa colonized or infected mechanically ventilated patients. Primary end point(s): The primary endpoint is to evaluate the safety and tolerability of a single dose of KB001 as determined by incidence and severity of treatment related AEs. Secondary Objective: The secondary objectives are to evaluate the pharmacodynamic and clinical effects of KB001 to aid in the design of future randomized efficacy studies. Specific objectives include the following:; • To explore pharmacodynamic and clinical effects of KB001 as measured by: ; ‐ Change in ETA Pa and microbial burden; ‐ Change in ETA measures of inflammation; ‐ Change in pulmonary function and clinical outcome ; • To evaluate the PK of a single dose of KB001 in this patient population, as well as to assess KB001 concentration in ETA; • To evaluate the potential immunogenicity of a single dose of KB001 INCLUSION CRITERIA: 1. Provision of written informed consent obtained from patient or patient’s surrogate if unconscious or altered sensorium 2. Age =18 years 3. On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days 4. Documented pulmonary Pa colonization (> 10 colonies per plate by semi‐quantitive culture or = 1000 CFU/mL by quantitative culture or PCR from ETA or = 100 CFU/mL by BAL) 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