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

NCT00691587 | Completed Phase 1

• 1 other identifier: KB001-04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudomonas Aeruginosa; Ventilator Associated Pneumonia

Keywords

mechanical ventilation; mechanically ventilated; Pseudomonas aeruginosa; ventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of a single dose of KB001.

  Day 28

Secondary Outcomes (1)

• To measure the pharmacodynamic effects of a single-dose of KB001.

  Day 28

Study Arms (3)

1

EXPERIMENTAL

Low-dose KB001, a monoclonal antibody

Biological: KB001

2

EXPERIMENTAL

High-dose KB001, a monoclonal antibody

Biological: KB001

3

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

KB001 BIOLOGICAL

Single low-dose, administered intravenously

1

Placebo BIOLOGICAL

Placebo single-dose, administered intravenously

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanigen, Inc.: lead

Study Sites (1)

Unknown Facility

Multiple Cities, France

Location

MeSH Terms

Conditions

Pseudomonas Infections; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Jean Chastre

  Hopital La Pitie Salpetriere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 31, 2009

Record last verified: 2009-07

Locations

FR (1)