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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Bulovka	Prague	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
University Hospital Olomouc	Olomouc	Czechia
Krajska zdravotni a.s.	Teplice	Czechia
University Hospital Ostrava	Ostrava	Czechia
Nemocnice Ceske Budejovice a.s.	Ceske Budejovice	Czechia
Krajska nemocnice Liberec a.s.	Liberec	Czechia
Fbqihwpv novvnbgrj Mjsvm a Hsymnmr	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.06.2025

Trial locations

Investigated drugs:

Vancomycin Hydrochloride

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.

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 ID:

2024-518607-21-00

Protocol code:

ANTROP-I

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?