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Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

NCT02940626 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2019-07-31

Study results available
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Summary

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

Conditions

  • Pneumonia, Ventilator-associated
  • Pneumonia, Staphylococcal

Interventions

DRUG

ASN100

monoclonal antibody combination of ASN-1 and ASN-2

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Arsanis, Inc.

    lead INDUSTRY

Principal Investigators

  • Arsanis, Inc · Arsanis, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-07-19
Completion
2018-09-28
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Czechia
  • France
  • Georgia
  • Hungary
  • India
  • Israel
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs

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 NCT02940626 on ClinicalTrials.gov