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Trial record 2 of 2 for:    MEDI3902

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696902
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET
Antibacterial Resistance Leadership Group
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 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
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : December 4, 2019

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



Information from the National Library of Medicine

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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


Locations
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United States, Colorado
Research Site
Englewood, Colorado, United States, 80113
United States, Florida
Research Site
Gainesville, Florida, United States, 32608
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
Research Site
Augusta, Georgia, United States, 30912
United States, Maryland
Research Site
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Research Site
Detroit, Michigan, United States, 48202
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45267
Austria
Research Site
Innsbruck, Austria, 6020
Research Site
Wien, Austria, 1080
Belgium
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Bruges, Belgium, 8000
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Brussels, Belgium, 1020
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Brussels, Belgium, 1090
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Haine-Saint-Paul, Belgium, 7100
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Ottignies, Belgium, 1340
Croatia
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Slavonski Brod, Croatia, 35000
Czechia
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Brno, Czechia, 656 91
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Decin, Czechia, 405 99
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Kolin, Czechia, 280 02
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Kyjov, Czechia, 697 01
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Teplice, Czechia, 415 29
France
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Argenteuil, France, 95107
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Clermont-ferrand, France, 63003
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Garches, France, 92380
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La Tronche, France, 38700
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Le Kremlin Bicetre, France, 94275
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Le Plessis Robinson, France, 92350
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Lille Cedex, France, 59037
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Limoges, France, 87042
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Montpellier Cedex 5, France, 34295
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Nancy, France, 54035
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Paris Cedex 14, France, 75014
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Paris, France, 75015
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Paris, France, 75651
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Paris, France, 75679
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Pierre Benite, France, 69495
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Strasbourg, France, 67090
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Tours, France, 37000
Greece
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Athens, Greece, 10676
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Athens, Greece, 11521
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Athens, Greece, 11527
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Athens, Greece, 14233
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Athens, Greece, 14564
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Larissa, Greece, 41110
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Larissa, Greece, 41221
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Thessaloniki, Greece, 54634
Hungary
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Budapest, Hungary, 1121
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Kistarcsa, Hungary, 02143
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Vác, Hungary, 2600
Ireland
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Dublin, Ireland, 6
Israel
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Jerusalem, Israel, 91120
Research Site
Petach-Tikva, Israel, 4941492
Research Site
Ramat Gan, Israel, 5265601
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Tel Aviv, Israel, 6423906
Portugal
Research Site
Almada, Portugal, 2805-267
Research Site
Lisboa, Portugal, 1449-005
Research Site
Lisboa, Portugal, 1649-035
Research Site
Viana do Castelo, Portugal, 4904-858
Spain
Research Site
Barcelona, Spain, 08025
Research Site
Barcelona, Spain, 08036
Research Site
Cordoba, Spain, 14004
Research Site
Getafe, Spain, 28905
Research Site
Madrid, Spain, 28040
Research Site
Oviedo, Spain, 33011
Research Site
San Sebastián de los Reyes, Spain, 28702
Research Site
Santander, Spain, 39008
Research Site
Tarragona, Spain, 43007
Research Site
Terrassa, Spain, 08221
Research Site
Valencia, Spain, 46026
Research Site
Valladolid, Spain, 47012
Turkey
Research Site
Ankara, Turkey, 6100
Research Site
Istanbul, Turkey, 34890
Research Site
Trabzon, Turkey, 61080
United Kingdom
Research Site
Edgbaston, United Kingdom, B15 2GW
Research Site
London, United Kingdom, SE1 7EH
Research Site
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
MedImmune LLC
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET
Antibacterial Resistance Leadership Group
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Director: MedImmune LLC MedImmune LLC
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02696902    
Other Study ID Numbers: D5470C00004
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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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:
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Pseudomonas Infections
Healthcare-Associated Pneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes