NCT00691587

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Humanigen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Pseudomonas Aeruginosa
• Ventilator Associated Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	KB001	Single low-dose, administered intravenously
BIOLOGICAL	KB001	Single high-dose, administered intravenously
BIOLOGICAL	Placebo	Placebo single-dose, administered intravenously

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-06-05
• Last updated: 2009-07-31

Locations

1 site across 1 country: France