E.Coli Infections Clinical Trial
Official title:
Pilot Study to Assess Success Factors And Barriers for Preparation of a Phase 3 Study With ExPEC10V in Adults Aged 60 Years or Older and in Stable Health
The purpose of this study is to collect information from study participants who develop a serious infection caused by a bacterium called E.coli during a period of 12 months. This information will be used to support the development of a new vaccine to prevent E.coli infections.
Invasive ExPEC disease (IED) is defined as an acute illness consistent with bacterial
infection that is microbiologically confirmed 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 and no other
identifiable source of infection. Adults aged 60 years or older have an increased risk of
developing IED. To date, there is no vaccine available to prevent IED. ExPEC10V is a 10
valent vaccine candidate in development by Janssen R&D for the prevention of IED in adults
aged 60 years and older. A Phase 3 clinical study is planned to investigate the efficacy and
safety of this vaccine. To obtain insight in the feasibility and design of the Phase 3 study,
a pilot study is required.
This pilot study is a prospective, multicenter, observational study conducted in a maximum of
eight countries in Europe, North-America and Asia. Participant recruitment will be done in
primary care. In each participating country a local primary care network encompassing
approximately 40,000 persons and a local hospital, where patients are referred to in case of
a suspicion of IED, will participate in this study.
Database screening at the primary care centers will be performed to identify and invite
potential eligible study participants. Upon consent, each study participant will be followed
for a period of maximum 12 months after enrollment in the study. At baseline, demographic
data and medical history data will be collected. During the follow-up period, any referral of
study participants to a hospital for any reason including IED will be collected. IED
identification and Medical Resource Utilization (MRU) during the follow-up period will be
done by performing regular telephone calls with all study participants. At the end of the
study, the primary care files will also be checked for MRU. If a participant is diagnosed
with IED and admitted to the hospital, the following data will be collected: medical history
and treatment received 90 days prior to the IED, clinical and laboratory data, data on the
treatment and outcome of IED and data on MRU related to IED. Data will be collected on Day 1
of IED diagnosis (signs/symptoms) and Day 28 after IED diagnosis. In addition, E. coli
bacteria cultured from blood, urine or other normally sterile body sites/fluid will be
isolated. Representative bacterial colonies will be identified to the species level as per
local laboratory procedures.
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