At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 213 enrolled
Drug / intervention
MEDI4893 +1 moredrug
Likely dose
MEDI4893 5000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.
In Brief
A Phase 2 clinical trial evaluating MEDI4893 and Placebo for Staphylococcus Aureus Pneumonia. Completed, enrolled 213 participants across 49 sites in 10 countries.
Detailed Summary
Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcus Aureus Pneumonia
CountriesBelgium, Czechia, France, Germany, Greece, Hungary, Portugal, Spain, Switzerland, United States
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionOct 2018
TodayJul 2026
First PostedNov 20, 2014
Enrollment StartOct 10, 2014
Primary CompletionOct 2, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.6 years ago
Interventions
MEDI4893drug
Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.
Placeboother
Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.