Summary

for people ages 18 years and up (full criteria)
at Saint Louis, Missouri and other locations
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Pseudomonas Aeruginosa Pneumonia Pseudomonas aeruginosa pneumonia Pseudomonas Infections Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

(main criteria):

  • being moribund
  • effective antibiotic therapy ≥48 hours
  • immunocompromised
  • underlying pulmonary disease that may preclude the assessment of a therapeutic response

Locations

  • Research Site
    Saint Louis Missouri 63110 United States
  • Research Site
    Columbus Ohio 43215 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aridis Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT03027609
Phase
Phase 2
Study Type
Interventional
Last Updated