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Completed

NCT Number: NCT03027609

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

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.

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Key information

Conditions

Pseudomonas Aeruginosa Pneumonia Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Lung Diseases Pneumonia Pseudomonas Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Adelaide, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)
  • pneumonia due to P. aeruginosa
  • mechanically-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

Treatment and study plan

AR-105

Drug

monoclonal antibody

Other names: Aerubumab, Aerucin

Placebo

Drug

matching placebo (+ SOC antibiotics)

Other names: Control (SOC antibiotics)

Primary outcomes

  1. Clinical Cure on Day 21

    Time frame: 21 days following dosing

    A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group

Secondary outcomes

  1. Clinical Cure on Day 7

    Time frame: 7 days following dosing

    A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group

  2. Clinical Cure on Day 14

    Time frame: 14 days following dosing

    A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group

  3. Clinical Cure on Day 28

    Time frame: 28 days following dosing

    A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group

Sponsors and collaborators

Lead sponsor

Aridis Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2017
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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