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Researcher

COMBACTE-NET-EXPECT

Start Date:

August 2019

End Date:

May 2022

Duration:

30 months

ID-CARE Role:
Website:

Partner

Description

Title: EXtraintestinal Pathogenic Escherichia Coli Trial (EXPECT)


Design: EXPECT1 - prospective observational pilot study; EXPECT2- prospective epidemiological study


Primary Objective: to provide a large network for rapid evaluation of novel treatment strategies; to generate innovative trial designs to facilitate the registration of novel antibacterial agents; and to design and validate tests to support the diagnosis of patients, identify the most appropriate treatments, and monitor the patient’s response.


Secondary Objective(s): 

  • EXPECT-1: to assess success factors and barriers for a future Phase 3 randomized controlled trial, where the efficacy of a new vaccine to prevent invasive ExPEC disease will be tested in community-dwelling adults.

  • EXPECT-2: To estimate the O-serotype distribution of ExPEC isolated from hospitalized patients aged 60 and older with invasive ExPEC disease, and to evaluate the clinical case definition and risk factors.

Partners

University of Utrecht - NETHERLANDS (Coordinator) 

Arbeitsgemeinschaft für Osteosynthesefragen (AO) Documentation and Publishing Foundation Clinical Investigation and Documentation - SWITZERLAND

Astra-Zeneca - ITALY

IDIBAPS August Pi i Sunyer Biomedical Research Institute - SPAIN

Centre Hospitalier Régional Universitaire de Besançon - FRANCE

Centre Hospitalier de LIMOGES - FRANCE

Cliniques Universitaries San Luc - BELGIUM

Da Volterra - ITALY

Eberhard Karls Universität Tuebingen - GERMANY

Erasmus Universitair Medisch Centrum Rotterdam - NETHERLANDS

European Clinical Research Infrastructure Network - FRANCE

University of Zurich - SWITZERLAND

European Forum for Good Clinical Practice - BELGIUM

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - ITALY

Fundacion Privada Instituto de Salud Global Barcelona - SPAIN

GlaxoSmithKline - UK

Goethe University Frankfurt - GERMANY

Guadeloupe

Helmholtz Centre for Infection Research - GERMANY

Hôpitaux Universitaires de Genève - SWITZERLAND

INSERM Institut National de la Santé Et de la Recherche Médicale - FRANCE

Instituto Nacional De Saùde - PORTUGAL

Janssen Infectious Diseases –Diagnostics

Julius Center Research Program Infectious Diseases - NETHERLANDS

Lausanne University Hospital - SWITZERLAND

Linköping Universitet - SWEDEN

Medical Center –University of Freiburg - GERMANY

North Bristol National Health Service Trust - UK

Radboud University Nijmegen Medical Centre - NETHERLANDS

Servicio Andaluz de Salud - SPAIN

Servicio Madrileño de Salud - SPAIN

Tel-Aviv Sourasky Medical Center - ISRAEL

The Medicines Company Rempex

University Hospital of Cologne - GERMANY

University Medicine of the Ernst Moritz Arndt - GERMANY

University of Antwerp - BELGIUM

University of Athens Medical School - GREECE

University of Greifswald - Germany

University of Oxford - UK

University of Verona - ITALY

Université Claude Bernard Lyon 1 - FRANCE

Université Joseph Fourier - FRANCE

Sponsor
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Publications

Infection

25/1/24

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Clinical presentation and antimicrobial resistance of invasive Escherichia coli disease in hospitalized older adults: a prospective multinational observational study

Clinical Microbiology and Infection

1/5/23

Clostridioides difficile infection (CDI): A pan-European multi-center cost and resource utilization study, results from the Combatting Bacterial Resistance in Europe CDI (COMBACTE-CDI)

Clinical Microbiology and Infection

1/12/22

Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases

ID-CARE Participants

Evelina Tacconelli

Director

Gaia Maccarrone

Clinical Research Assistant

Elda Righi

Associate Professor

Ruth Joanna Davis

Project Officer

Anna Maria Azzini

Lecturer and Consultant Physician

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