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Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects

NCT02696902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2021-02-04

Study results available
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Summary

Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Conditions

  • Pseudomonas Aeruginosa

Interventions

DRUG

MEDI3902

Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.

OTHER

Placebo

Participants will receive a single IV dose of placebo matched to MEDI3902.

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
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-25
Primary Completion
2019-12-04
Completion
2019-12-04
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • France
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Portugal
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

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 NCT02696902 on ClinicalTrials.gov