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Completed

NCT Number: NCT00691587

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

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.

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Key information

Conditions

Pseudomonas Aeruginosa Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Negative Bacterial Infections Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Pseudomonas Infections Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Multiple Cities, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KB001

Biological

Single low-dose, administered intravenously

Placebo

Biological

Placebo single-dose, administered intravenously

Primary outcomes

  1. The safety and tolerability of a single dose of KB001.

    Time frame: Day 28

Secondary outcomes

  1. To measure the pharmacodynamic effects of a single-dose of KB001.

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Humanigen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2008
Registry last updated
Jul 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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