Epidemiological Study in Patients with Invasive ExPEC Disease (IED)
Research type
Research Study
Full title
Epidemiological Study to Estimate the O-serotype Distribution of Extraintestinal Pathogenic Escherichia coli (ExPEC) Isolated From Hospitalized Patients of All Age Groups With Invasive ExPEC Disease (IED) and to Evaluate the Clinical Case Definition and Risk Factors
IRAS ID
252008
Contact name
Andrew Kirby
Contact email
Sponsor organisation
Janssen EMEA
Duration of Study in the UK
0 years, 10 months, 13 days
Research summary
The sponsor is currently developing vaccines for the prevention of Invasive Extraintestinal Pathogenic Escherichia Coli (E-Coli) (ExPEC) disease (IED).
Invasive ExPEC disease is defined as an acute illness consistent with bacterial infection, and microbiology confirmed by isolation and identification of E-coli from blood and other normally sterile body sites and/or urine.
ExPEC is the most common cause of infection in humans resulting from Gram-negative bacteria. ExPEC comprises a pathogenic group of E. coli strains, possessing the ability to colonise and infect normally sterile body sites and to cause severe IED.This hospital based retrospective epidemiological study will assess the different types of E-Coli isolates causing IED. Demographic and clinical data will also be collected to examine this patient population. The clinical criteria of IED used by sites will be compared with the proposed case definition for future clinical studies, and the health burden associated with IED in terms of Medical Resource utilisation and costs will be considered.
No study drug will be administered in this retrospective, non-interventional study.
Patients with an IED diagnosis within the last 12 months prior to start of data collection, who were hospitalised for IED and have a culture-confirmed E-Coli infection are eligible. Patients will be identified through patients medical and laboratory records by site staff. Patients will have a corresponding stored bacterial isolate which will be sent to a central lab for analysis. Bacterial isolates are pure strains of bacteria (do not contain human tissue/samples).
Retrospective data collection available during the past 12 months will include demographic, clinical, laboratory and Medical Resource Utilisation. Only data available per clinical practice/stored isolates will be collected, no additional data will be requested. Participants will not be required to do anything for this study.
The end of study will be the last data collection time point for the last patient included in the study.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1934
Date of REC Opinion
5 Nov 2018
REC opinion
Favourable Opinion