Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli-2 (EXPECT-2)

Completed

Conditions studied: E. Coli Infection

In brief

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

Key facts

Study ID

NCT04117113

Run by

UMC Utrecht

People needed

238

Starts

2019-10-22

Expected to finish

2021-05-12

Last updated by the study team

2021-09-21

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no exclusion criteria for this study.

Where it is running

• Duke Clinical Research Institute — Durham, North Carolina, United States
• Duke Clinical Research Institute — Greater Sudbury, Canada
• CHU Limoges - CIC — Limoges, France
• UKK Uniclinic Cologne — Cologne, Germany
• University of Verona — Verona, Italy
• Janssen Pharmaceutical K.K. — Tokyo, Chiyoda-ku, Japan
• Andalusian Public Foundation for Health Research Management in Seville (FISEVI) — Seville, Spain
• University of Oxford — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.