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

NCT03027609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2022-03-17

Study results available
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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.

Conditions

  • Pseudomonas Aeruginosa Pneumonia

Interventions

DRUG

AR-105

monoclonal antibody

DRUG

Placebo

matching placebo (+ SOC antibiotics)

Sponsors & Collaborators

  • Aridis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2019-04-25
Completion
2019-04-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belarus
  • Belgium
  • Czechia
  • France
  • Georgia
  • Greece
  • Hungary
  • Mexico
  • Peru
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027609 on ClinicalTrials.gov