COMBACT-NET-EXPECT
Start Date
January 2019
Duration
30 months
Title: EXtraintestinal Pathogenic Escherichia Coli Trial (EXPECT)
Design: EXPECT1 - prospective observational pilot study; EXPECT2- prospective epidemiological study
Registration Number: Clinical Trials.Gov, Expect 1- NCT04087681; Expect 2- NCT04117113
Primary Objective: COMBACTE-NET aims 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.
Interested in collaboration? Contact Anna Maria Azzini (annamaria.azzini@univr.it)
Publications: Submitted
Partners
University of Utrecht (Coordinator)
Arbeitsgemeinschaft für Osteosynthesefragen Documentation and Publishing Foundation Clinical Investigation and Documentation,
Astra-Zeneca,
August Pi i Sunyer Biomedical Research Institute,
Centre Hospitalier Régional Universitaire de Besançon,
Centre Hospitalier de LIMOGES,
Cliniques Universitaries San Luc, Da Volterra,
Eberhard Karls Universität Tuebingen, Erasmus Universitair Medisch Centrum Rotterdam,
European Clinical Research Infrastructure Network,
University of Zurich,
European Forum for Good Clinical Practice,
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy,
Fundacion Privada Instituto de Salud Global Barcelona,
GlaxoSmithKline,
Goethe University Frankfurt,
Guadeloupe,
Helmholtz Centre for Infection Research,
Hôpitaux Universitaires de Genève,
INSERM,
Instituto Nacional De Saùde, Portugal,
Janssen Infectious Diseases –Diagnostics,
Julius Center Research Program Infectious Diseases,
Lausanne University Hospital, Linköping Universitet,
Medical Center –University of Freiburg,
North Bristol National Health Service Trust, UK,
Radboud University Nijmegen Medical Centre,
Servicio Andaluz de Salud,
Servicio Madrileño de Salud,
Tel-Aviv Sourasky Medical Center,
The Medicines Company Rempex,
University Hospital of Cologne,
University Medicine of the Ernst Moritz Arndt,
University of Antwerp,
University of Athens Medical School,
University of Greifswald, Germany,
University of Oxford,
University of Verona,
Université Claude Bernard Lyon 1,
Université Joseph Fourier
ID-CARE
Anna Maria Azzini
Elda Righi
Evelina Tacconelli
Gaia Maccarrone