Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

Study Overview
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Brief Summary
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Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

Detailed Description
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This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

Conditions
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Pseudomonas Aeruginosa, Ventilator Associated Pneumonia

Intervention / Treatment
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* Biological: KB001
* Biological: KB001
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium Age >18 years On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days Documented pulmonary Pa colonization Exclusion Criteria: Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis) Patient currently diagnosed with Pa VAP Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours Use of an investigational medication within 4 weeks prior to randomization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low-dose KB001, a monoclonal antibody | Biological: KB001<br>* Single low-dose, administered intravenously<br>|
| Experimental: 2<br>High-dose KB001, a monoclonal antibody | Biological: KB001<br>* Single high-dose, administered intravenously<br>|
| Placebo Comparator: 3<br>Placebo | Biological: Placebo<br>* Placebo single-dose, administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of a single dose of KB001. |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the pharmacodynamic effects of a single-dose of KB001. |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, mechanically ventilated, Pseudomonas aeruginosa, ventilator associated pneumonia