Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia

• Status: Completed
• Trial end date: 2019-04-25
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aridis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Informed consent

• ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)

• pneumonia due to P. aeruginosa

• ventilated

• intubated

• APACHE II score between 10 and 35

Exclusion Criteria (main criteria):

• being moribund

• effective antibiotic therapy ≥48 hours

• immunocompromised

• underlying pulmonary disease that may preclude the assessment of a therapeutic response