Status:
COMPLETED
Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
Lead Sponsor:
Humanigen, Inc.
Conditions:
Pseudomonas Aeruginosa
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 tha...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00691587
Start Date
April 1 2008
End Date
April 1 2009
Last Update
July 31 2009
Active Locations (1)
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1
Multiple Cities, France