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EVADE
Current status: Active Recruiting
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Effort to Prevent Nosocomial Pneumonia  caused by Pseudomonas aeruginosa in Mechanically ventilated Subjects

EVADE is a Phase II, randomized, controlled safety and efficacy trial of MEDI3902. It is a bispecific monoclonal antibody against two Pseudomonas aeruginosa proteins, for the prevention of ventilator-associated pneumonia in adult ICU-patients. In collaboration with MedImmune/AstraZeneca, up to 120 ICUs will participate in this study.

Getting around P. aeruginosa

Pseudomonas aeruginosa is one of the most important pathogens for critically ill patients treated in intensive-care units (ICUs). It is intrinsically resistant to many antibiotics and has a remarkable capacity to acquire novel resistance mechanisms. Acquisition can occur either due to mutations under direct antibiotic pressure. Or through horizontal gene transfer of resistance genes. Especially threatening are carbapenem‐resistant variants of P. aeruginosa. The mechanisms and transmission pathways underlying the success of these clones are far from understood. Furthermore, P. aeruginosa has well‐characterized virulence factors, such as PsI and PcrV toxins.

Antibodies as prevention strategy

Historically there are a small number of new antibiotics in the pipeline to treat infections caused by multidrug resistant P. aeruginosa. Protection against virulence factors and toxins offers a novel potential infection prevention strategy. In fact, monoclonal antibodies are increasingly being tested as an adjuvant therapy for hospital‐acquired infections. Based on ground-breaking studies, the first antibody‐based therapeutic options for multidrug resistant P. aeruginosa infections have recently been clinically evaluated.

Study information

EVADE is a Phase II, randomized, controlled safety and efficacy trial of MEDI3902. In close collaboration with MedImmune (the global biologics research and development arm of AstraZeneca), up to 120 ICUs across Europe will participate in this study. Aiming to assess the effectiveness of MEDI3902 as a preventive measure for P. aeruginosa infections. Especially of ventilator-associated pneumonia in adult ICU patients.

Study team members

  • Antoni Torres Marti

    Principal Investigator / Academic co-lead / Hospital Clinic de Barcelona

  • Ariel Pfleiderer

    EFPIA / MedImmune

Study level information

General information
  • Study NO NCT02696902
  • Study Name EVADE
  • Study Type Phase II
  • Study Status Active Recruiting
  • Enrollment Period 03/16 - 02/21
Enrollment
  • Total subjects planned 286
  • Total subjects screened 689
  • Total subjects enrolled 123
  • Total subjects completed 119

Study timeline

Light blue
Preparation phase
Dark blue
Trial period

Country level information

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Sites planned 3
Sites activated 1
Austria
Subjects
planned
0
Subjects
enrolled
1
Subjects
completed
0
Subjects completed
0.0%
Sites planned 6
Sites activated 5
Belgium
Subjects
planned
0
Subjects
enrolled
19
Subjects
completed
0
Subjects completed
0.0%
Sites planned 2
Sites activated 1
Croatia
Subjects
planned
0
Subjects
enrolled
3
Subjects
completed
0
Subjects completed
0.0%
Sites planned 6
Sites activated 5
Czech Republic
Subjects
planned
0
Subjects
enrolled
3
Subjects
completed
0
Subjects completed
0.0%
Sites planned 17
Sites activated 18
France
Subjects
planned
0
Subjects
enrolled
30
Subjects
completed
0
Subjects completed
0.0%
Sites planned 10
Sites activated 7
Greece
Subjects
planned
0
Subjects
enrolled
16
Subjects
completed
0
Subjects completed
0.0%
Sites planned 4
Sites activated 3
Hungary
Subjects
planned
0
Subjects
enrolled
6
Subjects
completed
0
Subjects completed
0.0%
Sites planned 1
Sites activated 0
Ireland
Subjects
planned
0
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
Sites planned 4
Sites activated 2
Subjects
planned
0
Subjects
enrolled
3
Subjects
completed
0
Subjects completed
0.0%
Sites planned 2
Sites activated 2
Portugal
Subjects
planned
0
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
Sites planned 11
Sites activated 11
Spain
Subjects
planned
0
Subjects
enrolled
11
Subjects
completed
0
Subjects completed
0.0%
Sites planned 3
Sites activated 3
Turkey
Subjects
planned
0
Subjects
enrolled
4
Subjects
completed
0
Subjects completed
0.0%
Sites planned 4
Sites activated 0
Great Britain
Subjects
planned
0
Subjects
enrolled
1
Subjects
completed
0
Subjects completed
0.0%