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

Sponsor

Humanigen, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00691587

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pseudomonas Aeruginosa Ventilator Associated Pneumonia	Biological: KB001 Biological: KB001 Biological: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Low-dose KB001, a monoclonal antibody	Biological: KB001 Single low-dose, administered intravenously
Experimental: 2 High-dose KB001, a monoclonal antibody	Biological: KB001 Single high-dose, administered intravenously
Placebo Comparator: 3 Placebo	Biological: Placebo Placebo single-dose, administered intravenously

Arm

Intervention/Treatment

Experimental: 1

Low-dose KB001, a monoclonal antibody

Biological: KB001

Single low-dose, administered intravenously

Experimental: 2

High-dose KB001, a monoclonal antibody

Biological: KB001

Single high-dose, administered intravenously

Placebo Comparator: 3

Placebo

Biological: Placebo

Placebo single-dose, administered intravenously

Outcome Measures

Primary Outcome Measures

The safety and tolerability of a single dose of KB001. [Day 28]

Secondary Outcome Measures

To measure the pharmacodynamic effects of a single-dose of KB001. [Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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