Performance of the Cepheid Methicillin-Resistant Staphylococcus aureus/S. aureus Skin and Soft Tissue Infection PCR Assay on Respiratory Samples from Mechanically Ventilated Patients for S. aureus Screening during the Phase 2 Double-Blind SAATELLITE Study

Author:

Ruzin Alexey1,Barraud Olivier2ORCID,Yu Li3,François Bruno2,Sánchez-Garcia Miguel4,Eggimann Philippe5,Dequin Pierre-François6,Laterre Pierre-François7,Huberlant Vincent8,Viña Lucia9,Boulain Thierry10,Bretonniere Cedric11,Pugin Jérôme12,Trenado José13,Hernandez Padilla Ana Catalina2,Vignaud Julie2,Vandamme Drieke2,Goossens Herman14,Lammens Christine14,Ali S. Omar1,Shoemaker Kathryn15,Ren Pin15,Colbert Susan16,Bellamy Terramika1,Sellman Bret R.1,McCarthy Michael17,Jafri Hasan S.1,Esser Mark T.1

Affiliation:

1. Early Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA

2. ICU and Inserm CIC-1435 and UMR-1092, Centre Hospitalier Universitaire de Limoges, Limoges, France

3. Statistical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA

4. Hospital Clinico San Carlos, Madrid, Spain

5. Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

6. Université François Rabelais, Tours, France

7. St. Luc University Hospital, Brussels, Belgium

8. Centre Hospitalier Jolimont-Lobbes, Lobbes, Belgium

9. Hospital Universitario Central de Asturias, Oviedo, Spain

10. Centre Hospitalier Régional d’Orléans, Orléans, France

11. Hôpital Guillaume et René Laennec, Nantes, France

12. Hôpitaux Universitaire de Genève, Geneva, Switzerland

13. Hospital Mutua de Terrassa, Terrassa, Spain

14. Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium

15. Late-Stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA

16. Development Operations, BioPharmaceuticals R&D, AstraZeneca, Wilmington, Delaware, USA

17. Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA

Abstract

We investigated the performance of the Xpert methicillin-resistant Staphylococcus aureus (MRSA)/ S. aureus skin and soft tissue (SSTI) quantitative PCR (qPCR) assay in SAATELLITE, a multicenter, double-blind, phase 2 study of suvratoxumab, a monoclonal antibody (MAb) targeting S. aureus alpha-toxin, for reducing the incidence of S. aureus pneumonia.

Funder

COMBACTE Consortium

Innovative Medicines Initiative Joint Undertaking

AstraZeneca

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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