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

Primary Purpose

Pseudomonas Aeruginosa, Ventilator Associated Pneumonia

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

KB001

Placebo

About this trial

This is an interventional prevention trial for Pseudomonas Aeruginosa focused on measuring mechanical ventilation, mechanically ventilated, Pseudomonas aeruginosa, ventilator associated pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Low-dose KB001, a monoclonal antibody

High-dose KB001, a monoclonal antibody

Placebo

Outcomes

Primary Outcome Measures

The safety and tolerability of a single dose of KB001.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00691587

First Posted

June 3, 2008

Last Updated

July 29, 2009

Sponsor

Humanigen, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00691587

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Humanigen, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pseudomonas Aeruginosa, Ventilator Associated Pneumonia

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Low-dose KB001, a monoclonal antibody

Arm Title

Arm Type

Experimental

Arm Description

High-dose KB001, a monoclonal antibody

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

KB001

Intervention Description

Single low-dose, administered intravenously

Intervention Type

Biological

Intervention Name(s)

KB001

Intervention Description

Single high-dose, administered intravenously

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo single-dose, administered intravenously

Primary Outcome Measure Information:

Title

The safety and tolerability of a single dose of KB001.

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Jean Chastre

Organizational Affiliation

Hopital La Pitie Salpetriere

Official's Role

Principal Investigator

Facility Information:

City

Multiple Cities

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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