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Trials
Current status: In preparation
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SAATELLITE-2

SAATELLITE-2 is a phase 3, randomized, double-blind, placebo-controlled, single-dosed trial, focusing on a human monoclonal antibody [AR-320 (suvratoxumab), formerly MEDI4893] against Staphylococcus aureus alpha toxin in mechanically ventilated adult and adolescent subjects. This bacterial toxin kills cells in patients and damages tissues and organs, which helps microbes to spread and cause serious infections and disease. Suvratoxumab would work against S. aureus, regardless of whether this bug is resistant to antibiotics. The clinical trial involves patients who are in an intensive-care unit (ICU) at high risk of developing nosocomial pneumonia caused by S. aureus.

THE POWER OF ANTIBODIES

Suvratoxumab is a novel, fully human monoclonal antibody, being developed to treat high-risk patients to prevent S. aureus pneumonia in the ICU setting. In the previous Phase 2 SAATELLITE study, suvratoxumab has been shown to exhibit a favourable safety profile and was associated with a reduction in S. aureus ICU pneumonia and shorter duration of ICU and hospital stays. The Phase 3 study is designed to confirm the efficacy of suvratoxumab in ICU patients in preventing S. aureus pneumonia.

Study information

The goal of this study is to test suvratoxumab in more than 500 mechanically ventilated adult and adolescent subjects in approximately 200 ICUs worldwide (with approximately 100 ICUs in Europe). ICU patients who need mechanical ventilation are tested for the presence of S. aureus in their lower airways before they develop pneumonia. If they test positive, they receive a single intravenous dose of suvratoxumab (or placebo) to determine whether suvratoxumab protects from developing pneumonia.

Study team members

  • Ana Hernandez

    LAB - MD/PhD student / Academic / CHU Limoges

  • Biljana Kakaraskoska Boceska

    LAB-Net Representative / Laboratory manager / Universiteit Antwerpen

  • Bruno Francois

    Principal Investigator / Academic leader / CHU Limoges

Study level information

General information
  • Study NO N/A
  • Study Name SAATELLITE-2
  • Study Type Phase III
  • Study Status Planned
  • Enrollment Period 05/22 - 10/22
Enrollment
  • Total subjects planned 0
  • Total subjects screened 0
  • Total subjects enrolled 0
  • Total subjects completed 0

Study timeline

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Preparation phase
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Trial period

Country level information

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Belgium
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planned 0
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France
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Greece
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Netherlands
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enrolled 0
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0.0%
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Portugal
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0.0%
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Spain
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planned 0
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enrolled 0
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completed 0
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0.0%

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