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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Wien, Austria, 1080
        • Research Site
  • Belgium
      • Bruges, Belgium, 8000
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 1020
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Haine-Saint-Paul, Belgium, 7100
        • Research Site
      • Ottignies, Belgium, 1340
        • Research Site
  • Croatia
      • Slavonski Brod, Croatia, 35000
        • Research Site
  • Czechia
      • Brno, Czechia, 656 91
        • Research Site
      • Decin, Czechia, 405 99
        • Research Site
      • Kolin, Czechia, 280 02
        • Research Site
      • Kyjov, Czechia, 697 01
        • Research Site
      • Teplice, Czechia, 415 29
        • Research Site
  • France
      • Argenteuil, France, 95107
        • Research Site
      • Clermont-ferrand, France, 63003
        • Research Site
      • Garches, France, 92380
        • Research Site
      • La Tronche, France, 38700
        • Research Site
      • Le Kremlin Bicetre, France, 94275
        • Research Site
      • Le Plessis Robinson, France, 92350
        • Research Site
      • Lille Cedex, France, 59037
        • Research Site
      • Limoges, France, 87042
        • Research Site
      • Montpellier Cedex 5, France, 34295
        • Research Site
      • Nancy, France, 54035
        • Research Site
      • Paris, France, 75015
        • Research Site
      • Paris, France, 75679
        • Research Site
      • Paris, France, 75651
        • Research Site
      • Paris Cedex 14, France, 75014
        • Research Site
      • Pierre Benite, France, 69495
        • Research Site
      • Strasbourg, France, 67090
        • Research Site
      • Tours, France, 37000
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 14564
        • Research Site
      • Athens, Greece, 14233
        • Research Site
      • Athens, Greece, 10676
        • Research Site
      • Athens, Greece, 11521
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Larissa, Greece, 41221
        • Research Site
      • Thessaloniki, Greece, 54634
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Kistarcsa, Hungary, 02143
        • Research Site
      • Vác, Hungary, 2600
        • Research Site
  • Ireland
      • Dublin, Ireland, 6
        • Research Site
  • Israel
      • Jerusalem, Israel, 91120
        • Research Site
      • Petach-Tikva, Israel, 4941492
        • Research Site
      • Ramat Gan, Israel, 5265601
        • Research Site
      • Tel Aviv, Israel, 6423906
        • Research Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Research Site
      • Lisboa, Portugal, 1649-035
        • Research Site
      • Lisboa, Portugal, 1449-005
        • Research Site
      • Viana do Castelo, Portugal, 4904-858
        • Research Site
  • Spain
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 08025
        • 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
        • Research Site
  • Turkey
      • Ankara, Turkey, 6100
        • Research Site
      • Istanbul, Turkey, 34890
        • Research Site
      • Trabzon, Turkey, 61080
        • Research Site
  • United Kingdom
      • Edgbaston, United Kingdom, B15 2GW
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Research Site
      • London, United Kingdom, SE1 7EH
        • Research Site
  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Research Site
    • Florida
      • Gainesville, Florida, United States, 32608
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
      • Augusta, Georgia, United States, 30912
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Research Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MEDI3902 500 mg
Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.
Drug: MEDI3902
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.
PLACEBO_COMPARATOR: Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
Other: Placebo
Participants will receive a single IV dose of placebo matched to MEDI3902.
EXPERIMENTAL: MEDI3902 1500 mg
Participants will receive a single IV dose of 1500 mg MEDI3902.
Drug: MEDI3902
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Time Frame: Day 1 through Day 22
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Day 1 through Day 22
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 50
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.
Day 1 through Day 50
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 through Day 50
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.
Day 1 through Day 50
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Time Frame: Day 1 through Day 50
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.
Day 1 through Day 50

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The Cmax of MEDI3902 is reported.
Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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
The AUC0-inf of MEDI3902 is reported.
Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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
The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
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
Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
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
The t1/2 of MEDI3902 is reported.
Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Time Frame: Day 1 (predose), Day 15, Day 29, Day 50
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.
Day 1 (predose), Day 15, Day 29, Day 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
Antibacterial Resistance Leadership Group
INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET

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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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