Patients with Pseudomonas aeruginosa Ventilator-Associated Pulmonary Infection MedDRA version: 9.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia
Conditions
Interventions
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 aeru
Sponsors
KaloBios Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis) 2. Patient currently diagnosed with PA VAP 3. Change in systemic antibiotic therapy active against gram negative bacteria within 72 hours prior to screening culture used for documenting pulmonary Pa colonization for study entry 4. Patients not expected to survive at least 3 days 5. Patient expected to be transferred to another institution during the 28 day study period 6. Women of childbearing potential with a positive serum pregnancy test 7. Use of an investigational medication within 4 weeks prior to randomization 8. Any other reason, which in the opinion of the Investigator would prevent the patient from completing participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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;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. | — |
Countries
France
Outcome results
None listed