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ANtibiotic TReatment OPtimisation – randomised controlled trial of Clostridioides difficile infection therapy (ANTROP-I)
EU CTIS ID: 2024-518607-21-00
What this study is testing
The primary objective is to verify the non-inferiority/superiority of 5-day treatment over the standard 10-day treatment of CDI with oral vancomycin.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult age (≥ 18 years) at the time of enrolment
- Presence of diarrhoea, i.e. ≥ 3 stools per day and a stool consistency that is not normal for the patient (mushy or watery stool)
- Conclusive laboratory confirmation of C. difficile infection from a stool sample (i.e. presence of C. difficile antigen [glutamate dehydrogenase, GDH] and toxin [type A/B])
- Hospitalisation at the time of enrolment
- Informed consent with participation in the clinical trial
- Fertile men and women of childbearing potential: Consent with own sexual abstinence during the active treatment phase (10 days).
You likely can't join if
- Life expectancy of the patient is less than 3 months
- Ongoing CDI episode is a recurrence (i.e. onset in ≤60 days from the last CDI episode)
- Known allergy/hypersensitivity to vancomycin or excipients of the investigational medical products
- Haemodynamic instability, critical condition or need for intensive care
- Toxic megacolon or need for surgical intervention
- The patient has started therapy for the current CDI episode with metronidazole, tigecycline, or fidaxomicin, or has already used more than 2 doses of vancomycin.
See the full eligibility criteria
- Adult age (≥ 18 years) at the time of enrolment
- Presence of diarrhoea, i.e. ≥ 3 stools per day and a stool consistency that is not normal for the patient (mushy or watery stool)
- Conclusive laboratory confirmation of C. difficile infection from a stool sample (i.e. presence of C. difficile antigen [glutamate dehydrogenase, GDH] and toxin [type A/B])
- Hospitalisation at the time of enrolment
- Informed consent with participation in the clinical trial
- Fertile men and women of childbearing potential: Consent with own sexual abstinence during the active treatment phase (10 days).
- Only for the sub-study: Written informed consent with participation in the sub-study and willingness to provide and collect stool samples repeatedly in the following 6 months.
- Life expectancy of the patient is less than 3 months
- Ongoing CDI episode is a recurrence (i.e. onset in ≤60 days from the last CDI episode)
- Known allergy/hypersensitivity to vancomycin or excipients of the investigational medical products
- Haemodynamic instability, critical condition or need for intensive care
- Toxic megacolon or need for surgical intervention
- The patient has started therapy for the current CDI episode with metronidazole, tigecycline, or fidaxomicin, or has already used more than 2 doses of vancomycin.
- Participation in another interventional clinical trial in the last 30 days or in a period equal to 5 half-lives of the respective investigational drug in that clinical trial, whichever is longer
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.