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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00691587

Enrollment

Registered

2008-06-05

Start date

2008-04-30

Completion date

2009-04-30

Last updated

2009-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudomonas Aeruginosa, Ventilator Associated Pneumonia

Keywords

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

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.

Interventions

BIOLOGICALKB001

Single low-dose, administered intravenously

BIOLOGICALPlacebo

Placebo single-dose, administered intravenously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The safety and tolerability of a single dose of KB001.	Day 28

Secondary

Measure	Time frame
To measure the pharmacodynamic effects of a single-dose of KB001.	Day 28

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026