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

This study has been completed.
Sponsor:
Information provided by:
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00691587
First received: June 3, 2008
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Pseudomonas Aeruginosa
Ventilator Associated Pneumonia
Biological: KB001
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • The safety and tolerability of a single dose of KB001. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure the pharmacodynamic effects of a single-dose of KB001. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691587

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

No publications provided

Responsible Party: Tillman Pearce, MD, Chief Medical Officer, KaloBios Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00691587     History of Changes
Other Study ID Numbers: KB001-04
Study First Received: June 3, 2008
Last Updated: July 29, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on September 18, 2014