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Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301

NCT03816956 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2023-07-06

No results posted yet for this study

Summary

AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.

Conditions

  • Lung Infection
  • Pneumonia, Ventilator-Associated
  • Infection, Bacterial
  • Staphylococcus Aureus

Interventions

DRUG

AR-301

AR-301 (tosatoxumab) 20 mg/kg administered once intravenously the day of enrolment.

OTHER

Placebo

Placebo comparator

Sponsors & Collaborators

  • Aridis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Hasan S Jafri, MD, FAAP · Aridis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2022-10-28
Completion
2022-10-28
FDA Drug
Yes

Countries

  • Belarus
  • Belgium
  • Brazil
  • China
  • Estonia
  • France
  • Georgia
  • Israel
  • Latvia
  • Mexico
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816956 on ClinicalTrials.gov