A Randomized, double-blind, placebo-controlled pilot study of KB001 in mechanically-ventilated patients colonized with pseudomonas aeruginosa

Conditions: Patients with Pseudomonas aeruginosa Ventilator-Associated Pulmonary Infection
MedDRA version: 9.1Level: LLTClassification code 10065153Term: Ventilator associated pneumonia

Registration Number: EUCTR2007-006764-29-FR

Lead Sponsor: KaloBios Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Provision of written informed consent obtained from patient or patient’s surrogate if unconscious or altered sensorium
2. Age =18 years
3. On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
4. Documented pulmonary Pa colonization (> 10 colonies per plate by semi-quantitive culture or = 1000 CFU/mL by quantitative culture or PCR from ETA or = 100 CFU/mL by BAL)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
2. Patient currently diagnosed with PA VAP
3. Change in systemic antibiotic therapy active against gram negative bacteria within 72 hours prior to screening culture used for documenting pulmonary Pa colonization for study entry
4. Patients not expected to survive at least 3 days
5. Patient expected to be transferred to another institution during the 28 day study period
6. Women of childbearing potential with a positive serum pregnancy test
7. Use of an investigational medication within 4 weeks prior to randomization
8. Any other reason, which in the opinion of the Investigator would prevent the patient from completing participation in the study