NCT03027609

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

Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Aridis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody (mAb) AR-105 for the adjunctive therapeutic treatment of P. aeruginosa pneumonia in mechanically ventilated subjects. Subjects who are randomized will be treated with either standard of care (SOC) antibiotics plus placebo or SOC antibiotics plus AR-105. The study is being conducted at approximately 100 clinical sites across 17 countries. Subjects who meet all of the inclusion criteria and none of the exclusion criteria are screened by the microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to confirm the presence of an active P. aeruginosa infection. Following eligibility confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.

Conditions

• Pseudomonas Aeruginosa Pneumonia

Interventions

Type	Name	Description
DRUG	AR-105	monoclonal antibody
DRUG	Placebo	matching placebo (+ SOC antibiotics)

Timeline

• Start date: 2017-03-29
• Primary completion: 2019-04-25
• Completion: 2019-04-25
• First posted: 2017-01-23
• Last updated: 2022-03-17
• Results posted: 2022-03-09

Locations

111 sites across 17 countries: United States, Australia, Belarus, Belgium, Czechia, France, Georgia, Greece, Hungary, Mexico, Peru, Poland, Russia, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study