Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00691587
Study type	Interventional
Source	KaloBios Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2008
Completion date	April 2009

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms