CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 158 enrolled
Drug / intervention
AR-105 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Diagnosis of pneumonia due to P. aeruginosa
  • ✓Mechanically ventilated and intubated
  • ✓Age ≥18 years (≥20 in Taiwan, ≥19 in South Korea)
  • ✓APACHE II score between 10 and 35
Key exclusion· 4
  • ✕Moribund status
  • ✕Effective antibiotic therapy for ≥48 hours prior to enrollment
  • ✕Immunocompromised status
  • ✕Underlying pulmonary disease that may confound assessment of therapeutic response

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03027609
NCT03027609Phase 2Completed
CompareCT.gov

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

Aridis Pharmaceuticals, Inc.·interventional·Posted Jan 23, 2017·Updated Mar 17, 2022

In Brief

A Phase 2 clinical trial evaluating AR-105 and Placebo for Pseudomonas Aeruginosa Pneumonia. Completed, enrolled 158 participants across 111 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPseudomonas Aeruginosa Pneumonia
CountriesAustralia, Belarus, Belgium, Czechia, France, Georgia, Greece, Hungary, Mexico, Peru, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 23, 2017
Enrollment StartMar 29, 2017
Primary CompletionApr 25, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.4 years ago

Interventions

AR-105drug

monoclonal antibody

Placebodrug

matching placebo (+ SOC antibiotics)