Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Optimizing Antibiotic Treatment for Clostridioides Difficile Infection with Vancomycin Hydrochloride in Adult Patients

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Clostridioides difficile infection, commonly known as C. difficile or CDI. This infection can cause severe diarrhea and other intestinal issues. The study will use a medication called vancomycin hydrochloride, which is taken orally in the form of hard capsules. The purpose of the study is to determine if a shorter, 5-day treatment with vancomycin is as effective as the standard 10-day treatment.

Participants in the study will be randomly assigned to receive either the 5-day or the 10-day course of vancomycin. Throughout the study, the health of participants will be monitored to assess the recurrence of CDI and overall recovery. Recovery is defined as a noticeable improvement in symptoms, such as reduced stool frequency and a return to normal stool consistency, without the appearance of new severe symptoms.

The study will also collect additional information, such as the presence of multidrug-resistant bacteria and changes in the gut microbiota, which are the microorganisms living in the intestines. This information will help researchers understand the broader effects of the treatment. The study is expected to continue until the end of 2027.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Eligibility is confirmed based on age (18 years or older), presence of diarrhea (3 or more stools per day with abnormal consistency), and laboratory confirmation of Clostridioides difficile infection (CDI).

    Hospitalization due to the current CDI episode is required at the time of enrollment.

    Informed consent is obtained for participation in the clinical trial.

  2. Step 2

    Treatment phase

    Participants are randomly assigned to receive either a 5-day or a 10-day treatment of oral vancomycin hydrochloride.

    The primary objective is to compare the effectiveness of the 5-day treatment to the standard 10-day treatment.

  3. Step 3

    Active treatment phase

    During the active treatment phase, participants are required to abstain from sexual activity for 10 days.

    Participants are monitored for recovery, defined as sustained clinical improvement for at least 48 hours, including reduced stool frequency and normalization of stool consistency.

  4. Step 4

    Follow-up

    The incidence of CDI recurrence is assessed during the 60 days following the end of the study treatment.

    Participants are monitored for any adverse events related to vancomycin, including their severity and duration.

  5. Step 5

    Sub-study (optional)

    Participants who consent to the sub-study provide stool samples over a 6-month period for further examination.

    The sub-study explores microbiota recovery, including the presence of multidrug-resistant bacteria.

Who can join the trial?

7 criteria

  • Must be an adult (18 years or older) at the time of joining the study.
  • Must have diarrhea, which means having 3 or more stools per day that are mushy or watery, and not normal for the patient.
  • Must have a confirmed Clostridioides difficile infection from a stool sample. This means the presence of a specific antigen and toxin in the stool.
  • Must be hospitalized due to the current infection at the time of joining the study.
  • Must give informed consent to participate in the clinical trial, meaning they understand and agree to the study's terms.
  • For men and women who can have children: Must agree to abstain from sexual activity during the 10-day treatment phase.
  • Only for those in the sub-study: Must provide written informed consent to participate in the sub-study and agree to provide stool samples over the next 6 months.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Clostridioides difficile infection cannot participate. This is a specific type of bacterial infection that affects the intestines.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population. This means groups of people who might be at higher risk of harm or exploitation.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Vancomycin is an antibiotic used to treat infections caused by certain bacteria. In this trial, it is used to treat Clostridioides difficile infection (CDI). The study is comparing the effectiveness of a 5-day treatment with vancomycin to the standard 10-day treatment to see if the shorter treatment is just as effective or better.

What is already known about the treatment

Vancomycin – This medication is administered orally and is used primarily to treat infections caused by Clostridioides difficile. It is currently well-established in medical practice and literature as an effective treatment for this type of infection. The main therapeutic indication for vancomycin is the treatment of Clostridioides difficile infection, particularly when other treatments have failed. At the molecular level, vancomycin works by inhibiting the synthesis of bacterial cell walls, which ultimately leads to the death of the bacteria. It is classified pharmacologically as a glycopeptide antibiotic.

Investigated diseases

Clostridioides difficile infection – This infection is caused by the bacterium Clostridioides difficile, which primarily affects the colon. It often occurs after the use of antibiotics, which can disrupt the normal balance of bacteria in the gut. Symptoms typically include diarrhea, abdominal pain, and fever. The infection can lead to inflammation of the colon, known as colitis. In some cases, it may cause severe complications like dehydration or bowel perforation. The disease can recur, especially if the bacterial balance in the gut is not restored.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518607-21-00Protocol codeANTROP-IEstimated enrolment244 patientsSponsorFakultni Nemocnice Bulovka

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.