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

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.

Timeline

Start

2017-03-29

Primary completion

2019-04-25

Completion

2019-04-25

Outcome

Missed primary endpoint

registry analysis (superiority test); AR-105 vs Control; p = 0.6154; Risk Difference (RD) -5.54 (95% CI -21.9 to 10.8) NCT03027609 ↗

Drugs

Indications