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

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691587
• Other study ID #: KB001-04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 3, 2008
• Last updated: July 29, 2009
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: KaloBios Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Pseudomonas Aeruginosa
• Pseudomonas Infections
• Ventilator Associated Pneumonia

Intervention

Biological:
• KB001
Single low-dose, administered intravenously
• KB001
Single high-dose, administered intravenously
• Placebo
Placebo single-dose, administered intravenously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KaloBios Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and tolerability of a single dose of KB001.		Day 28
Secondary	To measure the pharmacodynamic effects of a single-dose of KB001.		Day 28