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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: KaloBios Pharmaceuticals

Current Primary Outcome: The safety and tolerability of a single dose of KB001. [ Time Frame: Day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To measure the pharmacodynamic effects of a single-dose of KB001. [ Time Frame: Day 28 ]

Original Secondary Outcome: Same as current

Information By: KaloBios Pharmaceuticals

Dates:
Date Received: June 3, 2008
Date Started: April 2008
Date Completion:
Last Updated: July 29, 2009
Last Verified: July 2009