Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04117113 |
| Other study ID # |
VAC52416BAC0006 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 22, 2019 |
| Est. completion date |
May 12, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
UMC Utrecht |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to collect information from study participants who are
hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC).
This information will be used to support the development of a new vaccine to prevent
Extraintestinal pathogenic Escherichia coli (ExPEC). E. coli bacteria are a leading cause of
serious infections. Especially adults older than 60 years have a higher risk of developing
such infections. To date, there is no vaccine available to prevent E. coli infections. To
support the development of a vaccine, more information about E. coli infections is first
needed. This information will be collected in the current study, such as:
- Medical information such as medical history, diagnosis, duration of hospitalization
- Treatment and outcome of the Extraintestinal pathogenic Escherichia coli (ExPEC)
- Laboratory information
Description:
Janssen Research & Development is developing ExPEC10V, a 10-valent conjugate vaccine
comprising the 10 most predominant O-polysaccharides of ExPEC.
Invasive ExPEC Disease (IED) is defined as an acute illness consistent with bacterial
infection that is microbiologically confirmed either by the isolation and identification of
E. coli from blood or other normally sterile body sites, or by the isolation and
identification of E. coli from urine in a patient with signs and symptoms of invasive disease
(presence of systemic inflammatory response syndrome [SIRS], sepsis or septic shock) and no
other identifiable source of infection.
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 ExPEC 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.
Although IED affects all age categories, adults aged 60 years or older have an increased risk
of developing IED, including bacteremia and sepsis. The incidence of community-acquired ExPEC
bacteremia increases with age, occurring at a rate of 150/100,000 person-years in the United
States (US) adults aged 65 years and older, and 452/100,000 person-years in adults aged 85
years and older. Similar trends have been observed in Europe. In the US, it is estimated that
up to 40,000 patients die annually due to IED, in particular from E. coli sepsis. Overall
case-fatality rates for ExPEC bacteremia range from 13% to 19% but may be much higher (up to
60%) in the elderly with healthcare-associated infections.
The increase in multidrug resistance (ie, resistance to two or more antibiotic classes) among
ExPEC strains, such as E. coli sequence type 131:O25B, represents a major challenge for
prevention and management of ExPEC infections. Global morbidity, hospitalization and
mortality rates due to ExPEC infections are substantial and increasing due to aging
populations and increasing prevalence of antibiotic resistant ExPEC strains, and associated
with increasing healthcare costs in both Europe and the US.
This hospital-based prospective epidemiological study will assess the O-serotype and
O-genotype distribution in E. coli isolates causing IED overall and by subgroup based on risk
factors. 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 proposed Phase 3 clinical case definition for
IED in adults aged 60 years or older for future clinical studies in this patient population.
No study drug will be administered in this non interventional study.
