Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Completed · Phase 2 · Has a placebo group
Conditions studied: Pseudomonas Aeruginosa Pneumonia
In brief
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.
Key facts
- Study ID
- NCT03027609
- Run by
- Aridis Pharmaceuticals, Inc.
- People needed
- 158
- Starts
- 2017-03-29
- Expected to finish
- 2019-04-25
- Last updated by the study team
- 2022-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Research Site — Lyon, France
- Research Site — Lyon, France
- Research Site — Nantes, France
- Research Site 1 — Paris, France
- Research Site 2 — Paris, France
- Research Site — Paris, France
- Research Site — Pierre-Bénite, France
- Research Site — Pontoise, France
- Research Site — Strasbourg, France
- Research Site — Tourcoing, France
- Research Site — Tours, France
- Research Site 1 — Kutaisi, Georgia
- Research Site 2 — Kutaisi, Georgia
- Research Site — Tbilisi, Georgia
- Research Site 1 — Athens, Greece
- Research Site 2 — Athens, Greece
- Research Site 1 — Larissa, Greece
- Research Site 2 — Larissa, Greece
- Research Site 3 — Budapest, Hungary
- Research Site 2 — Budapest, Hungary
- Research Site 1 — Budapest, Hungary
- Research Site — Debrecen, Hungary
- Research Site — Nyíregyháza, Hungary
- Research Site 1 — Guadalajara, Mexico
- Research Site — Limoges, France
Full record on ClinicalTrials.gov
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