Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escheric… (NCT04117113) | Clinical Trial Compass
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 range
60 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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.