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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pseudomonas Aeruginosa Pneumonia

Intervention / Treatment
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* Drug: AR-105
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR-105<br>One intravenous infusion of AR-105 20mg/'kg | Drug: AR-105<br>* monoclonal antibody<br>* Other names: Aerucin;|
| Placebo Comparator: Control<br>Matching placebo | Drug: Placebo<br>* matching placebo (+ SOC antibiotics)<br>* Other names: Control (SOC antibiotics);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure on Day 21 | A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group | 21 days following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure on Day 7 | A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group | 7 days following dosing | 
| Clinical Cure on Day 14 | A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group | 14 days following dosing | 
| Clinical Cure on Day 28 | A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group | 28 days following dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudomonas aeruginosa, pneumonia