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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
Results First Posted : December 23, 2020
Last Update Posted : February 4, 2021
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 participants 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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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 participants.


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
Show Show 78 study locations
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
  Study Documents (Full-Text)

Documents provided by MedImmune LLC:
Study Protocol  [PDF] June 6, 2018
Statistical Analysis Plan  [PDF] February 17, 2020

Additional Information:
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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
Results First Posted: December 23, 2020
Last Update Posted: February 4, 2021
Last Verified: January 2021

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