Antimicrobial Stewardship Program for Clostridium Difficile Infection. (NCT02951481) | Clinical Trial Compass
CompletedNot Applicable
Antimicrobial Stewardship Program for Clostridium Difficile Infection.
Spain403 participantsStarted 2017-02-15
Plain-language summary
The purpose of this study is to determine whether a bundle of measures specifically designed for patients with ICD and applied by and Infectious Diseases expert during a year period (2017) will improve the prognosis and reduce the rate of recurrence, compared with the baseline phase (2015) in which no intervention was made.
Who can participate
Age range
18 Years – 110 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 diagnosed with CDI in the University Hospital "12 de Octubre", Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (estimated start date: January 2017).
* Patient or his/her representative sign the inform consent
Exclusion Criteria:
* Patients younger than 18 years of age.
* Patients with the diagnosis of inflammatory bowel disease.
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.
1This trial studied whether an antimicrobial stewardship program could reduce C. difficile recurrence — since the trial is now completed, has my doctor seen the results, and do they change how recurrence prevention is approached in my care?
2Since this trial measured recurrence of C. difficile infection as its main outcome, what is my personal risk of recurrence based on my specific situation, and are any of the stewardship strategies studied here already being used in my treatment plan?
3This was a non-drug program study rather than a medication trial — does that mean there are fewer safety concerns to weigh, and what would participating in a stewardship program actually require of me day-to-day?
4Because the trial focused on antibiotic management practices rather than a new drug, is there a standard-of-care approach to antimicrobial stewardship my doctor already recommends for C. difficile patients like me, separate from any trial?
5Given that this trial is completed, would my doctor be able to access or share any published findings from it, and could those results influence whether I try a different C. difficile treatment approach before considering other options?
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
Number of Participants With Clostridium Difficile Infection Recurrence.
Timeframe: Within 8 weeks after the end of treatment.