Clostridium difficile colitis – Trials in Disease

Go back

Ongoing Clinical Trials for Clostridium Difficile Colitis

There is currently 1 ongoing clinical trial for Clostridium Difficile Colitis (also known as: Clostridioides difficile infection, CDI, C. difficile infection). This trial is investigating whether a shorter antibiotic treatment course can effectively treat this infection, which causes severe diarrhea and intestinal inflammation.

Clinical trial locations

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

This clinical trial is examining whether a shorter antibiotic treatment can be just as effective as the standard approach for treating Clostridioides difficile infection. The infection, commonly called C. difficile or CDI, causes severe diarrhea and other intestinal problems, often occurring after taking antibiotics that disrupt the normal balance of gut bacteria.

Main focus: The study aims to determine if a 5-day course of vancomycin is as effective as the standard 10-day treatment. Vancomycin is an antibiotic that works by breaking down the cell walls of the C. difficile bacteria, ultimately killing them. Patients enrolled in the trial will be randomly assigned to receive either the shorter 5-day treatment or the standard 10-day treatment, both using oral vancomycin hydrochloride capsules.

Who can participate: The trial is open to adults aged 18 years or older who have been hospitalized due to CDI. To be eligible, participants must have diarrhea (defined as three or more mushy or watery stools per day) and have laboratory confirmation of the infection through stool testing that shows the presence of specific antigens and toxins. Participants must provide informed consent and agree to abstain from sexual activity during the 10-day treatment phase. Those who wish to join an optional sub-study must also agree to provide stool samples over a 6-month period.

Who cannot participate: The trial excludes patients who do not have a confirmed diagnosis of CDI, those who fall outside the specified age range, and individuals who are part of vulnerable populations that might be at higher risk of harm or exploitation during the study.

What the study involves: Throughout the trial, researchers will monitor participants to assess their recovery, which is defined as sustained improvement in symptoms for at least 48 hours, including fewer bowel movements and a return to normal stool consistency. The study will track whether the infection returns during the 60 days following treatment completion. Additionally, researchers will monitor for any side effects related to vancomycin, recording their severity and duration.

For those who participate in the optional sub-study, stool samples will be collected over six months to examine changes in the gut microbiota (the community of microorganisms living in the intestines) and to check for the presence of multidrug-resistant bacteria. This additional information will help researchers understand the broader effects of different treatment durations on gut health. The study is expected to continue until the end of 2027.

Summary

Currently, there is one active clinical trial for Clostridium Difficile Colitis, taking place in Czechia. This trial focuses on optimizing antibiotic treatment by comparing a shorter 5-day course of vancomycin to the standard 10-day treatment. The study specifically investigates vancomycin hydrochloride, a well-established antibiotic used to treat CDI by targeting the bacterial cell wall.

The trial is particularly significant for hospitalized patients with confirmed CDI who are seeking effective treatment options. By examining whether a shorter treatment duration can achieve similar results to the standard approach, this research may help reduce antibiotic exposure while maintaining treatment effectiveness. The optional sub-study component also adds value by exploring long-term effects on gut health and antibiotic resistance patterns.

Ongoing Clinical Trials on Clostridium difficile colitis

Connected medications: