CompletedNot Applicable

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

United States, Canada, France238 participantsStarted 2019-10-22

Plain-language 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

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: • There are no exclusion criteria for this study.

What they're measuring

Distribution of E. coli O-serotypes causing IED in adults aged 60 years or older, as percentage of the total study population.

Timeframe: 12 months

Distribution of E. coli O-genotypes causing IED in adults aged 60 years or older, as percentage of the total study population.

Timeframe: 12 months

Distribution of IED in adults aged 60 years or older over the following clinical case definitions: "Pyelonephritis", "Urosepsis", "Meningitis", "Arthritis", "Sepsis of unknown origin" and "Others", as a percentage of the total study population.

Timeframe: 12 months

Trial details

NCT IDNCT04117113

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-31

View on ClinicalTrials.gov More E. Coli Infection trials

Plain-language summary

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Distribution of E. coli O-serotypes causing IED in adults aged 60 years or older, as percentage of the total study population.

Timeframe: 12 months

Distribution of E. coli O-genotypes causing IED in adults aged 60 years or older, as percentage of the total study population.

Timeframe: 12 months