Title
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
Phase
Phase 2Lead Sponsor
Aridis Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pseudomonas Aeruginosa PneumoniaIntervention/Treatment
aerubumab ...Study Participants
158Prospective, 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.
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.
monoclonal antibody
matching placebo (+ SOC antibiotics)
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
| Event Type | Organ System | Event Term | AR-105 | Control |
|---|
A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group
A summary of the number (%) of patients who were cured on or before Day 7 (micro-ITT population) is provided, by treatment group
A summary of the number (%) of patients who were cured on or before Day 14 (micro-ITT population) is provided by treatment group
A summary of the number (%) of patients who were cured on or before Day 28 (micro-ITT population) is provided by treatment group
Difference in percentage of clinical cure rates between the two treatment groups
Difference in percentage of clinical cure rates between the two treatment groups
