Phase 2
N=158
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Pseudomonas Aeruginosa Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT03027609 ↗Enrolled (actual)
158
Serious AEs
36.7%
Results posted
Mar 2022
Primary outcome: Primary: Clinical Cure on Day 21 — 34; 37; 6; 5 Participants — p=0.6154
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AR-105 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aridis Pharmaceuticals, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure on Day 21 |
34; 37; 6; 5; 25; 20 | 0.6154 |
| SECONDARY Clinical Cure on Day 7 |
16; 18; 0; 0; 52; 47 | 0.8426 |
| SECONDARY Clinical Cure on Day 14 |
36; 31; 1; 2; 29; 30 | 0.3562 |
| SECONDARY Clinical Cure on Day 28 |
35; 38; 9; 6; 23; 16 | 0.8472 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03027609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.