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

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ClinicalTrials.gov Identifier: NCT02696902
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET
Antibacterial Resistance Leadership Group (ARLG)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
MedImmune LLC

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

Condition or disease Intervention/treatment Phase
Pseudomonas Aeruginosa Drug: MEDI3902 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Pseudomonas Aeruginosa
Actual Study Start Date : March 25, 2016
Estimated Primary Completion Date : February 19, 2021
Estimated Study Completion Date : February 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: MEDI3902 Drug: MEDI3902
Active

Placebo Comparator: Placebo Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum. [ Time Frame: 49 days post dose ]
    Cmax

  2. Anti-drug Antibody (ADA) responses to MEDI3902 in serum [ Time Frame: 49 days post dose ]
    Incidence and titers of ADA to MEDI3902 in serum

  3. Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum. [ Time Frame: 49 days post dose ]
    Tmax

  4. Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum [ Time Frame: 49 days post dose ]
    t1/2

  5. Single-dose pharmacokinetic (PK) parameters of MEDI3902 in serum. [ Time Frame: 49 days post dose ]
    AUC



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund patients.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696902


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
MedImmune LLC
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET
Antibacterial Resistance Leadership Group (ARLG)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Director: MedImmune LLC MedImmune LLC

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02696902     History of Changes
Other Study ID Numbers: D5470C00004
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by MedImmune LLC:
Pseudomonas aeruginosa, Pneumonia

Additional relevant MeSH terms:
Pneumonia
Pseudomonas Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Negative Bacterial Infections
Bacterial Infections