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

Humanigen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ventilator Associated Pneumonia; Pseudomonas Aeruginosa

Treatments: Biological: Placebo; Biological: KB001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00691587

KB001-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

36 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Low-dose KB001, a monoclonal antibody

Treatment:

Biological: KB001

Biological: KB001

2

Experimental group

Description:

High-dose KB001, a monoclonal antibody

Treatment:

Biological: KB001

Biological: KB001

3

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo