This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-HRE will be compared to those from hospitalized patients with healthcare-associated HRE (HA-HRE). In addition, community spread of CRE will be determined.
Who can participate
Age range
18 Years – 99 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:
Category 1: Patients who live at home and meet the following criteria:
* CDC-defined HRE isolated during a previous hospitalization or outpatient visit
* Home origin
* First positive HRE culture within 48 hours of admission (in case of hospitalization)
Category 2: Hospitalized patients with CDC-defined HRE isolated during hospitalization who are not discharged home and who meet any of the following criteria:
* Admitted from other care facility (not home origin)
* Do not have first positive HRE culture within 48 hours of admission
Category 3: Patients with CDC-defined HRE isolated during a previous hospitalization or outpatient visit who are eventually discharged home and who meet any of the following criteria:
* Admitted from other care facility (not home origin)
* Do not have first positive HRE culture within 48 hours of admission (in case of hospitalization)
Category 4: Participants who meet the following criteria:
• Community contact of a participant in Category 1 and/or 3.
Exclusion Criteria:
In all categories, participants who meet the following criteria will be excluded:
• Age \<18 years
In category 1, the following are exclusionary:
* pre-existing renal failure
* pre-existing liver disease
* immunocompromised
* history of malignancy
* pregnancy
In addition, in category 1, 3 and 4, who meet the following criteria will be excluded:
• Unable to provide informed consent
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
Proportion of CA-HRE infections
Timeframe: enrollment - end of study, up to approximately 1 year
2
Proportion of HRE-culture positive community contacts of hospitalized patients with HRE as determined by stool culture.
Timeframe: enrollment - end of study, up to approximately 1 year