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Study of the Efficacy and Safety of MEDI4893

NCT02296320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2019-12-23

Study results available
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Summary

Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Conditions

  • Staphylococcus Aureus Pneumonia

Interventions

DRUG

MEDI4893

Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.

OTHER

Placebo

Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.

Sponsors & Collaborators

  • Innovative Medicines Initiative

    collaborator OTHER

  • Antibacterial Resistance Leadership Group

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • MedImmune LLC · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-10
Primary Completion
2018-10-02
Completion
2018-10-02
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Portugal
  • Spain
  • Switzerland

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 NCT02296320 on ClinicalTrials.gov