Status:
COMPLETED
Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli-2 (EXPECT-2)
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Janssen Research & Development, LLC
Innovative Medicines Initiative
Conditions:
E. Coli Infection
Eligibility:
All Genders
60+ years
Brief 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...
Detailed 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 acut...
Eligibility Criteria
Inclusion
- Patients aged 60 years or older and hospitalized for IED at the start of the study.
- Culture confirmation of E. coli (1) in normally sterile body sites including blood, and/or (2) in urine in the presence of clinical criteria of an invasive infection (raise in SOFA score \>1, sepsis, or septic shock consequent to the infection).
- For those countries and/or study sites where no waiver for informed consent/assent has been obtained prior to data collection, eligible patients must sign a participation agreement/ICF/IAF allowing data collection and source data verification in accordance with local requirements and/or sponsor policy. For deceased patients, a participation agreement/ICF/IAF must be signed by the patient's next of kin.
Exclusion
- • There are no exclusion criteria for this study.
Key Trial Info
Start Date :
October 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04117113
Start Date
October 22 2019
End Date
May 12 2021
Last Update
September 21 2021
Active Locations (8)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701
2
Duke Clinical Research Institute
Greater Sudbury, Canada
3
CHU Limoges - CIC
Limoges, France, 87042
4
UKK Uniclinic Cologne
Cologne, Germany, 50937