Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp i… (NCT04229511) | Clinical Trial Compass
UnknownNot Applicable
Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp in Colonized Patients
Turkey (Türkiye)520 participantsStarted 2020-04
Plain-language summary
DETERMINE trial is a prospective multicenter multinational cohort study. This study will be carried out to predict the risk of bloodstream infections (BSIs) or other types of invasive infection with carbapenem resistant K.pneumoniae in patients being colonized by CRKp. The results of DETERMINE trial would be quite important to prevent unnecessary coverage of carbapenem resistant Klebsiella pneumoniae in empirical treatment of colonized patients. In this study, both risk score model and decision tree algorithm will be constructed and compared with each other in terms of sensitivity, specificity, positive predictive value and negative predictive value.
Who can participate
Age range
18 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:
* All adult (≥18 years) patients having rectal colonization or history of previous invasive infection with CRKp
* Group 1 cases are constituted by one BSI episode or non-bactereamic invasive infection episode (eg. pneumonia, intra-abdominal infection or urinary tract infection) with CRKp and a positive rectal swab screening or invasive infection (e.g. pneumonia, urinary tract infection and BSI) with CRKp within 90 days before identification of index BSI or other invasive infection with CRKp
* Group 2 cases who are colonized with CRKp or had invasive infection (e.g. pneumonia, urinary tract infection and BSI) with CRKp within 90 days before identification of index BSI or other types of invasive infection with any bacteria other than CRKp and develop subsequent BSI or non-bactereamic invasive infection with these bacteria
* Group 3 cases involve the colonized patients with CRKp who do not develop subsequent BSI or other invasive infections with CRKp or any other bacteria
Exclusion Criteria:
* \<18 years old patients
* Palliative patients
* Pregnant and breast-feeding patients
* Patients who cannot be followed through 90-days.
* Patients who are de-colonized with antibiotics, prebiotics-probiotics or fecal microbiota transplantation
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
The factors that are associated with the development of subsequent BSI or other types of invasive infection with CRKp in CRKp carriers.
Timeframe: 90-day
Trial details
NCT IDNCT04229511
SponsorSCARE (Study group for carbapenem resistance)