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Study treatment for Ventilator-Associated Pneumonia (AR-301-002 Trial)

Phase 3
Waitlist Available
Research Sponsored by Aridis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, and 28
Awards & highlights

AR-301-002 Trial Summary

This study is evaluating whether a drug may help treat ventilator-associated pneumonia.

Eligible Conditions
  • Ventilator-Associated Pneumonia
  • Pneumonia
  • Staph Infection
  • Bacterial Infection

AR-301-002 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, 14, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, 14, and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A comparison of Clinical Cure Rates of standard of care (SOC) alone and SOC with AR-301
Safety of AR-301 by treatment-emergent adverse events assessed by changes between treatment and placebo as assessed by the Principal Investigator
Tolerability of AR-301 measured by the number of participants with treatment-emergent adverse events classified using CTCAE v 5.0
Secondary outcome measures
Changes in baseline in SOFA score between Standard of Care alone or with AR301 at Days 7,14,28
Antibiotics
Duration hospitalization
+12 more

AR-301-002 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study treatmentExperimental Treatment1 Intervention
Investigational/ Interventional Product group: AR-301 (tosatoxumab) 20 mg/kg administered once intravenously on the day of randomization.
Group II: Placebo treatmentPlacebo Group1 Intervention
Control group: Placebo administered intravenously on the day of randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AR-301
2019
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Aridis Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
888 Total Patients Enrolled
Lynne M Deans, MTStudy DirectorAridis Pharmaceuticals
3 Previous Clinical Trials
895 Total Patients Enrolled
Hasan S Jafri, MD, FAAPStudy DirectorAridis Pharmaceuticals
1 Previous Clinical Trials
102 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301
2019. "Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03816956.
~29 spots leftby Apr 2025
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