- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696902
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects (EVADE)
January 19, 2021 updated by: MedImmune LLC
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
Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
188
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Innsbruck, Austria, 6020
- Research Site
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Wien, Austria, 1080
- Research Site
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Bruges, Belgium, 8000
- Research Site
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Brussels, Belgium, 1090
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Brussels, Belgium, 1020
- Research Site
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Genk, Belgium, 3600
- Research Site
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Gent, Belgium, 9000
- Research Site
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Haine-Saint-Paul, Belgium, 7100
- Research Site
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Ottignies, Belgium, 1340
- Research Site
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Slavonski Brod, Croatia, 35000
- Research Site
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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
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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, France, 75015
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Paris, France, 75679
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Paris, France, 75651
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Paris Cedex 14, France, 75014
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Pierre Benite, France, 69495
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Strasbourg, France, 67090
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Tours, France, 37000
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Athens, Greece, 11527
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Athens, Greece, 14564
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Athens, Greece, 14233
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Athens, Greece, 10676
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Athens, Greece, 11521
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Larissa, Greece, 41110
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Larissa, Greece, 41221
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Thessaloniki, Greece, 54634
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Budapest, Hungary, 1121
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Kistarcsa, Hungary, 02143
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Vác, Hungary, 2600
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Dublin, Ireland, 6
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Jerusalem, Israel, 91120
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Petach-Tikva, Israel, 4941492
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Ramat Gan, Israel, 5265601
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Tel Aviv, Israel, 6423906
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Almada, Portugal, 2805-267
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Lisboa, Portugal, 1649-035
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Lisboa, Portugal, 1449-005
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Viana do Castelo, Portugal, 4904-858
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Barcelona, Spain, 08036
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Barcelona, Spain, 08025
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Cordoba, Spain, 14004
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Getafe, Spain, 28905
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Madrid, Spain, 28040
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Oviedo, Spain, 33011
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San Sebastián de los Reyes, Spain, 28702
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Santander, Spain, 39008
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Tarragona, Spain, 43007
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Terrassa, Spain, 08221
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Valencia, Spain, 46026
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Valladolid, Spain, 47012
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Ankara, Turkey, 6100
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Istanbul, Turkey, 34890
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Trabzon, Turkey, 61080
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Edgbaston, United Kingdom, B15 2GW
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London, United Kingdom, SE5 9RS
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London, United Kingdom, SE1 7EH
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Colorado
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Englewood, Colorado, United States, 80113
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Florida
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Gainesville, Florida, United States, 32608
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Georgia
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Atlanta, Georgia, United States, 30322
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Augusta, Georgia, United States, 30912
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Maryland
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Annapolis, Maryland, United States, 21401
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Massachusetts
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Boston, Massachusetts, United States, 02111
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Michigan
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Detroit, Michigan, United States, 48202
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Ohio
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Cincinnati, Ohio, United States, 45267
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 participants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: MEDI3902 500 mg
Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
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Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
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PLACEBO_COMPARATOR: Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
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Participants will receive a single IV dose of placebo matched to MEDI3902.
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EXPERIMENTAL: MEDI3902 1500 mg
Participants will receive a single IV dose of 1500 mg MEDI3902.
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Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Time Frame: Day 1 through Day 22
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Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
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Day 1 through Day 22
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 50
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Day 1 through Day 50
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Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 through Day 50
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An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Day 1 through Day 50
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Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Time Frame: Day 1 through Day 50
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An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor.
An AESI may be serious or non-serious.
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Day 1 through Day 50
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum Observed Concentration (Cmax) of MEDI3902
Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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The Cmax of MEDI3902 is reported.
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Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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The AUC0-inf of MEDI3902 is reported.
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Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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Clearance (CL) of MEDI3902
Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
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Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
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Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
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Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
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Terminal Elimination Half-life (t1/2) of MEDI3902
Time Frame: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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The t1/2 of MEDI3902 is reported.
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Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Time Frame: Day 1 (predose), Day 15, Day 29, Day 50
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Number of participants with positive ADA to MEDI3902 treatment is reported.
Persistent positive is defined as positive at >= 2 post-baseline assessments or positive at last post-baseline assessment.
Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments.
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Day 1 (predose), Day 15, Day 29, Day 50
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 25, 2016
Primary Completion (ACTUAL)
December 4, 2019
Study Completion (ACTUAL)
December 4, 2019
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
February 25, 2016
First Posted (ESTIMATE)
March 2, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 4, 2021
Last Update Submitted That Met QC Criteria
January 19, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia
- Pseudomonas Infections
Other Study ID Numbers
- D5470C00004
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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