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OpenTrials
Completed

NCT Number: NCT02696902

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEDI3902

Drug

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

Other

Participants will receive a single IV dose of placebo matched to MEDI3902.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • Antibacterial Resistance Leadership Group
  • Innovative Medicines Initiative
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Acronym: EVADE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2016
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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