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

NCT00691587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-07-31

No results posted yet for this study

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.

Conditions

  • Pseudomonas Aeruginosa
  • Ventilator Associated Pneumonia

Interventions

BIOLOGICAL

KB001

Single low-dose, administered intravenously

BIOLOGICAL

KB001

Single high-dose, administered intravenously

BIOLOGICAL

Placebo

Placebo single-dose, administered intravenously

Sponsors & Collaborators

  • Humanigen, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Jean Chastre · Hopital La Pitie Salpetriere

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • France

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00691587 on ClinicalTrials.gov