Clinical Trial: Study of the Efficacy and Safety of MEDI4893

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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

Detailed Summary:
Sponsor: MedImmune LLC

Current Primary Outcome:

  • Safety of single intravenous (IV) doses of MEDI4893 as measured by adverse events and clinical laboratory parameters.. [ Time Frame: Subjects will be followed through Day 91 for adverse events and through Day 191 for serious adverse events ]
    Safety of MEDI4893 as measured by adverse events and clinical laboratory parameters.
  • Efficacy of single intravenous (IV) doses of MEDI4893 as measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Incidence of Staphylococcus Aureus pneumonia through Day 31 ]
    Efficacy of MEDI4893 as measured by clinical symptoms of pneumonia and other Staphylococcus serious infection


Original Primary Outcome:

  • Safety of single intravenous (IV) doses of MEDI4893 as measured by adverse events and clinical laboratory parameters.. [ Time Frame: Subjects will be followed through Day 91 for adverse events and through Day 361 for serious adverse events ]
    Safety of MEDI4893 as measured by adverse events and clinical laboratory parameters.
  • Efficacy of single intravenous (IV) doses of MEDI4893 as measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Incidence of Staphylococcus Aureus pneumonia through Day 31 ]
    Efficacy of MEDI4893 as measured by clinical symptoms of pneumonia and other Staphylococcus serious infection


Current Secondary Outcome:

  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    Cmax
  • Anti-drug Antibody (ADA) responses to MEDI4893 in serum [ Time Frame: Subjects will be followed through Day 91 for ADA ]
    Incidence and titers of ADA to MEDI4893 in serum
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    Tmax
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    t1/2
  • Single-dose pharmacokinetic (PK) parameters of MEDI4893 in serum. [ Time Frame: Subjects will be followed through Day 91 for PK ]
    AUC
  • Incidence of Staphylococcus aureus pneumonia on mechanical ventilation Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Subjects will be followed through Day 31 for Staphylococcus aureus pneumonia ]
    Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection
  • Incidence of Staphylococcus aureus pneumonia after mechanical ventilation no longer required Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection. [ Time Frame: Subjects will be followed through Day 31 for Staphylococcus aureus pneumonia ]
    Measured by clinical symptoms of pneumonia and other Staphylococcus serious infection


Original Secondary Outcome: Same as current

Information By: MedImmune LLC

Dates:
Date Received: October 30, 2014
Date Started: October 10, 2014
Date Completion: October 14, 2019
Last Updated: April 25, 2017
Last Verified: April 2017