Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | March 29, 2017 |
| End Date: | April 28, 2019 |
Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of 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.
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.
(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.
Inclusion Criteria:
- 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
Exclusion Criteria (main criteria):
- being moribund
- effective antibiotic therapy ≥48 hours
- immunocompromised
- underlying pulmonary disease that may preclude the assessment of a therapeutic
response
We found this trial at
3
sites
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