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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00691587
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : July 31, 2009
Sponsor:
Information provided by:

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: 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  (Clinical Trial)
Estimated 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 : April 2008
Primary Completion Date : March 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. The safety and tolerability of a single dose of KB001. [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. To measure the pharmacodynamic effects of a single-dose of KB001. [ Time Frame: Day 28 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691587


Locations
France
Multiple Cities, France
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Principal Investigator: Prof. Jean Chastre Hopital La Pitie Salpetriere
More Information

Responsible Party: Tillman Pearce, MD, Chief Medical Officer, KaloBios Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00691587     History of Changes
Other Study ID Numbers: KB001-04
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: July 31, 2009
Last Verified: July 2009

Keywords provided by KaloBios Pharmaceuticals:
mechanical ventilation
mechanically ventilated
Pseudomonas aeruginosa
ventilator associated pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Pseudomonas Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Gram-Negative Bacterial Infections
Bacterial Infections