EXPECT-2
Research type
Research Study
Full title
Prospective Epidemiological Study to Estimate the O-serotype Distribution of Extraintestinal Pathogenic Escherichia coli (ExPEC) Isolated from Hospitalized Patients Aged 60 Years or Older with Invasive ExPEC Disease (IED) and to Evaluate the Clinical Case Definition
IRAS ID
269226
Contact name
Christopher Butler
Contact email
Sponsor organisation
University Medical Centre Utrecht
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Extraintestinal pathogenic E.coli (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 colonize and infect normally sterile body sites and to cause invasive extraintestinal disease (IED). ExPEC causes the vast majority of urinary tract infections (UTIs), is the second most frequent cause of neonatal bacteremia and meningitis, and is a leading cause of adult IED, in particular bacteremia and sepsis.
The increase in multidrug resistance (ie, resistance to two or more antibiotic classes) among ExPEC strains represents a major challenge for prevention and management of ExPEC infections and a vaccine is urgently needed.
This hospital-based prospective epidemiological study will assess the O-serotype and O-genotype distribution in E. coli isolates causing IED in support of the development of a safe and effective vaccine. Detailed demographic and clinical data, including information on hospital routes, from patients with IED will be collected in this study to further characterize the clinical setting in this patient population. This study will also provide data to compare the clinical criteria of IED used by the study site with the protocol clinical case definition for IED in adults aged 60 years or older for future clinical studies in this patient population including a proposed phase 3 vaccine study. No study drug will be administered in this non interventional study and it will be conducted at one hospital site aiming to recruit 30 particiapnts.
This study is funded by the Innovative Medicines Initiative Joint as part of the COMBACTE programme and is composed of financial contributions from the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA (European Federation of Pharmaceutical Industries and Associations).
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/1414
Date of REC Opinion
30 Sep 2019
REC opinion
Further Information Favourable Opinion