- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691587
Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
July 29, 2009 updated by: Humanigen, Inc.
A Randomized, Double-Blind, Placebo-Controlled 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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Multiple Cities, France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
Placebo
|
Placebo single-dose, administered intravenously
|
Experimental: 1
Low-dose KB001, a monoclonal antibody
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Single low-dose, administered intravenously
Single high-dose, administered intravenously
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Experimental: 2
High-dose KB001, a monoclonal antibody
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Single low-dose, administered intravenously
Single high-dose, administered intravenously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The safety and tolerability of a single dose of KB001.
Time Frame: Day 28
|
Day 28
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure the pharmacodynamic effects of a single-dose of KB001.
Time Frame: Day 28
|
Day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prof. Jean Chastre, Hôpital La Pitié Salpêtrière
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
July 31, 2009
Last Update Submitted That Met QC Criteria
July 29, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia
- Pneumonia, Ventilator-Associated
- Pseudomonas Infections
Other Study ID Numbers
- KB001-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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