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Study on Preventing C. difficile Infections with Oral Vancomycin in Patients Undergoing Allogeneic Stem Cell Transplantation

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What is this trial about?

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

This clinical trial is focused on preventing Clostridium difficile infections in patients who are undergoing a medical procedure called allogeneic hematopoietic stem cell transplantation. This procedure involves replacing a patient's blood-forming cells with those from a donor. The study will use a medication called vancomycin, which is an antibiotic, to see if it can help prevent these infections. Some patients will receive vancomycin, while others will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate if taking oral vancomycin can effectively prevent Clostridium difficile infections in these patients. Participants in the study will be randomly assigned to receive either vancomycin or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will be monitored for signs of Clostridium difficile infection, which can cause symptoms like diarrhea. The study will last for several weeks, and participants will be observed from the time they are included in the study until they are discharged from the hospital or until the end of the treatment period. The study aims to provide valuable information on whether vancomycin can be a useful preventive treatment for these infections in patients undergoing this type of transplantation.

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

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being at least 15 years old, hospitalized for less than 72 hours for an allogeneic hematopoietic stem cell transplantation, and providing consent for participation.

    Patients of childbearing age must use effective contraception during the study and for one month after the end of treatment.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with either oral vancomycin or a placebo. The treatment aims to prevent Clostridium difficile infections.

    The treatment duration is up to 5 weeks, depending on the patient's hospitalization status.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment, the patient will be monitored for signs of Clostridium difficile infection, which includes diarrhea with more than three unformed stools per day.

    Regular assessments will be conducted to detect the presence of the bacteria and any toxins in the stool.

  4. Step 4

    End of treatment

    The treatment concludes after 5 weeks or upon discharge from the hospital, whichever comes first.

    The patient's response to the treatment and any side effects will be documented.

  5. Step 5

    Follow-up period

    After the treatment ends, the patient will be monitored for up to 12 weeks to observe any delayed effects or infections.

    The study will also assess the patient's intestinal microbiota at various points, including at the start, during, and after the treatment.

Who can join the trial?

5 criteria

  • Be at least 15 years old.
  • Be hospitalized for less than 72 hours to receive a type of treatment called an allograft of hematopoietic stem cells (HSC). This is a procedure where healthy blood-forming cells are given to a patient.
  • If you are a man or woman who can have children, you must use effective birth control during the study and for one month after the treatment ends. Effective birth control means methods that have a failure rate of less than 1% per year.
  • Have given your consent to participate in the study. This means you agree to be part of the study after understanding what it involves.
  • Be a beneficiary of health insurance. This means you have health insurance coverage.

Who cannot join the trial?

3 criteria

  • Patients who are not hospitalized for an allogeneic hematopoietic stem cell transplantation cannot participate. This is a type of procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who are not within the specified age ranges cannot participate. The age ranges include children, adolescents, and adults.
  • Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Vancomycin is an antibiotic used in this trial to prevent infections caused by Clostridium difficile. It is given orally to patients who are undergoing allogeneic hematopoietic stem cell transplantation. The goal is to see if taking vancomycin can help stop these infections from happening in the first place.

What is already known about the treatment

Vancomycin – This medication is administered orally and is currently being studied for its effectiveness in preventing Clostridium difficile infections in patients undergoing allogeneic hematopoietic stem cell transplantation. In medical literature, vancomycin is well-known as an antibiotic used to treat serious bacterial infections. Its main therapeutic indication in this trial is the prevention of C. difficile infections. 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

Clostridium difficile infection – This infection is caused by the bacterium Clostridium difficile, which can lead to inflammation of 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. In severe cases, it can cause pseudomembranous colitis, a condition characterized by the formation of a membrane on the colon's surface. The infection is primarily spread through contact with contaminated surfaces or fecal matter. It is a common concern in healthcare settings, particularly among patients with weakened immune systems or those undergoing treatments like stem cell transplantation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513490-45-00Protocol codeAPHP210089Estimated enrolment336 patientsSponsorAssistance Publique Hopitaux De Paris

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