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

NCT ID: NCT00691587

Last Updated: 2009-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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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

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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

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Pseudomonas Aeruginosa Ventilator Associated Pneumonia

Keywords

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mechanical ventilation mechanically ventilated Pseudomonas aeruginosa ventilator associated pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Low-dose KB001, a monoclonal antibody

Group Type EXPERIMENTAL

KB001

Intervention Type BIOLOGICAL

Single low-dose, administered intravenously

2

High-dose KB001, a monoclonal antibody

Group Type EXPERIMENTAL

KB001

Intervention Type BIOLOGICAL

Single high-dose, administered intravenously

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo single-dose, administered intravenously

Interventions

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KB001

Single low-dose, administered intravenously

Intervention Type BIOLOGICAL

KB001

Single high-dose, administered intravenously

Intervention Type BIOLOGICAL

Placebo

Placebo single-dose, administered intravenously

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanigen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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KaloBios Pharmaceuticals, Inc.

Principal Investigators

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Prof. Jean Chastre

Role: PRINCIPAL_INVESTIGATOR

Hopital La Pitie Salpetriere

Locations

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Multiple Cities, , France

Site Status

Countries

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France

Other Identifiers

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KB001-04

Identifier Type: -

Identifier Source: org_study_id