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Current status: Completed
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SAATELLITE

Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects (SAATELLITE) is a Phase II, randomized, double-blind, placebo-controlled trial. Involving patients who are at high risk of developing ventilator-associated pneumonia in an intensive-care unit. The trial will test the safety, the pharmacokinetic and pharmacodynamic characteristics, and the efficacy of MEDI4893. A novel treatment that uses antibodies against S. aureus.

The power of antibodies

MEDI4893, developed by AstraZeneca, is a promising monoclonal antibody against S. aureus alpha toxin. The toxin kills cells in patients and damages tissues and organs, which helps microbes to spread and cause serious infections and disease. MEDI4893 uses an antibody – not an antibiotic – against this alpha toxin. Prevention would work against S. aureus, regardless of whether this bug is resistant to antibiotics. Another benefit is that this antibody approach is not expected to lead to new antibiotic resistance.

Study information

The study tested MEDI4893 in approximately 200 adult patients, in 60 to 80 ICUs across Europe. Patients in intensive-care units who need mechanical ventilation were tested for the presence of S. aureus in their lower airways before they developed a full-fledged infection and pneumonia. If they tested positive, they received a single intravenous dose of MEDI4893 antibody. Which protects them from developing pneumonia.

Study team members

  • Bruno Francois

    Principal Investigator / Academic leader / Centre Hospitalier Universitaire de Limoges

Study level information

General information
  • Study NO NCT02296320
  • Study Name SAATELLITE
  • Study Type Phase II
  • Study Status Database Lock
  • Enrollment Period 10/14 - 12/18
Enrollment
  • Total subjects planned 285
  • Total subjects screened 767
  • Total subjects enrolled 213
  • Total subjects completed 213

Study timeline

Light blue
Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 9
Sites activated 10
Belgium
Subjects
planned
0
Subjects
enrolled
26
Subjects
completed
10
Subjects completed
0.0%
Sites planned 9
Sites activated 6
Czech Republic
Subjects
planned
0
Subjects
enrolled
5
Subjects
completed
2
Subjects completed
0.0%
Sites planned 22
Sites activated 12
France
Subjects
planned
0
Subjects
enrolled
109
Subjects
completed
86
Subjects completed
0.0%
Sites planned 10
Sites activated 4
Germany
Subjects
planned
0
Subjects
enrolled
3
Subjects
completed
0
Subjects completed
0.0%
Sites planned 8
Sites activated 4
Greece
Subjects
planned
0
Subjects
enrolled
4
Subjects
completed
1
Subjects completed
0.0%
Sites planned 4
Sites activated 2
Hungary
Subjects
planned
0
Subjects
enrolled
3
Subjects
completed
3
Subjects completed
0.0%
Sites planned 0
Sites activated 0
Ireland
Subjects
planned
0
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
Sites planned 1
Sites activated 1
Portugal
Subjects
planned
0
Subjects
enrolled
2
Subjects
completed
0
Subjects completed
0.0%
Sites planned 11
Sites activated 9
Spain
Subjects
planned
0
Subjects
enrolled
35
Subjects
completed
18
Subjects completed
0.0%
Sites planned 3
Sites activated 3
Switzerland
Subjects
planned
0
Subjects
enrolled
16
Subjects
completed
10
Subjects completed
0.0%
Sites planned 6
Sites activated 0
Great Britain
Subjects
planned
0
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
07/09/2020

Introducing COMBACTE-NET's WP7B

15/07/2020

EXPECT-2 Enrolls 3/4 of Subjects