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

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

Official Title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomo

Brief Summary: Clinical Trial looking to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

Detailed Summary:
Sponsor: MedImmune LLC

Current Primary Outcome:

  • Safety of single intravenous (IV) doses of MEDI3902 as measured by adverse events and clinical laboratory parameters. [ Time Frame: 49 days post dose ]
    Safety of MEDI3902 as measured by adverse events and clinical laboratory parameters.
  • Efficacy of single intravenous (IV) doses of MEDI3902 as measured by signs and symptoms of nosocomial pneumonia caused by P aeruginosa [ Time Frame: 21 days post dose ]
    Nosocomial pneumonia will be diagnosed using signs and symptoms, including a culture positive for P aeruginosa and X-ray positive for pneumonia


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum. [ Time Frame: 49 days post dose ]
    Cmax
  • Anti-drug Antibody (ADA) responses to MEDI3902 in serum [ Time Frame: 49 days post dose ]
    Incidence and titers of ADA to MEDI3902 in serum
  • Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum. [ Time Frame: 49 days post dose ]
    Tmax
  • Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum [ Time Frame: 49 days post dose ]
    t1/2
  • Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum. [ Time Frame: 49 days post dose ]
    AUC
  • Incidence of nosocomial pneumonia caused by P aeruginosa while on mechanical ventilation. [ Time Frame: 21 days post dose ]
    Nosocomial pneumonia will be diagnosed using signs and symptoms, including a culture positive for P aeruginosa and X-ray positive for pneumonia
  • Incidence of nosocomial pneumonia caused by P aeruginosa after mechanical ventilation is no longer required. [ Time Frame: 21 days post dose ]
    Nosocomial pneumonia will be diagnosed using signs and symptoms, including a culture positive for P aeruginosa and X-ray positive for pneumonia


Original Secondary Outcome: Same as current

Information By: MedImmune LLC

Dates:
Date Received: February 11, 2016
Date Started: March 25, 2016
Date Completion: February 22, 2019
Last Updated: March 13, 2017
Last Verified: March 2017