Oral Vancomycin for C. difficile

Overseen By Jennifer Emel

Age: 65+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Maryland, Baltimore

Must not be taking: Probiotics, C diff treatments

Disqualifiers: Age 64 or younger, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether oral vancomycin, an antibiotic, can prevent Clostridioides difficile infections, a type of gut infection, in individuals taking antibiotics. Participants will receive either oral vancomycin with their antibiotics or the usual antibiotic treatment. The study lasts about three months and suits individuals 65 and older who have been on antibiotics, hospitalized within the last 90 days, and have a history of C. diff presence without past infections. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are currently taking medications to treat or prevent C. diff, you will need to stop them to participate in this trial. Other medications are not specifically mentioned, so you may not need to stop them, but it's best to discuss with the trial team.

Is there any evidence suggesting that oral vancomycin is likely to be safe for humans?

Research has shown that oral vancomycin is generally well-tolerated. One study found it effective in reducing symptoms of C. difficile infection, though it also caused changes to gut bacteria. While it targets the infection, it might affect other beneficial bacteria in the stomach.

Another study found that participants taking oral vancomycin experienced fewer repeat infections, but the difference was not significant enough to attribute solely to the treatment. This suggests it helped some, but not all, participants.

Overall, oral vancomycin has been used safely in many patients. However, like any treatment, it can have side effects. Prospective trial participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about oral vancomycin for C. difficile because it offers a targeted approach to treating this infection. Unlike the standard treatments that often involve general antibiotics, oral vancomycin directly targets the C. difficile bacteria in the gut. This precise action can potentially reduce the risk of disturbing the beneficial bacteria in the digestive system, which is a common issue with broad-spectrum antibiotics. Additionally, the oral delivery method ensures that the medication acts right where it's needed, potentially leading to faster and more effective treatment outcomes.

What evidence suggests that oral vancomycin might be an effective treatment for C. difficile?

Research has shown that oral vancomycin can help prevent repeat Clostridioides difficile infections (CDI). In one study, 43.6% of people taking oral vancomycin experienced another infection, compared to 57.1% of those taking a placebo, indicating that vancomycin can reduce the risk of recurrent CDI. Another study found that oral vancomycin temporarily reduced the presence of C. difficile in individuals with the bacteria but no symptoms. In this trial, participants in the oral vancomycin treatment arm will receive 125 mg twice daily. Overall, these findings suggest that oral vancomycin might help prevent CDI, especially when used during antibiotic treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey Marshall, MD

Principal Investigator

University of Maryland, Baltimore Washington Medical Center

Are You a Good Fit for This Trial?

This trial is for patients who are currently taking antibiotics and are at risk of developing Clostridioides difficile infection (CDI). Participants must be willing to take oral vancomycin or follow standard care without it for about 3 months. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Hospitalized anywhere in the last 90 days

Provided informed consent

Read and understand the English language

Exclusion Criteria

Has not been hospitalized in the last 90 days

Not provided informed consent

Cannot read and understand the English language

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral vancomycin twice daily for the duration of systemic antibiotic use plus two additional days

Up to 4 weeks

Visits as per antibiotic treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, including perirectal swabs for VRE detection

Up to 3 months

At start and end of antibiotic treatment

What Are the Treatments Tested in This Trial?

Interventions

• Vancomycin

Trial Overview The study tests if oral vancomycin can prevent CDI when taken alongside other antibiotics. Participants will be randomly assigned to either receive oral vancomycin twice daily with their antibiotic regimen, or follow the standard care without vancomycin.

How Is the Trial Designed?

Group I: Oral Vancomycin Experimental Treatment 1 Intervention

The oral vancomycin treatment group will receive oral vancomycin 125 mg twice daily for the duration of the concomitant antibiotic plus two additional days.

Group II: No Oral Vancomycin Active Control 1 Intervention

The no oral vancomycin control group will receive the current standard of care treatment which is an antibiotic with no oral vancomycin.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

University of Maryland, Baltimore Washington Medical Center

Collaborator

Trials

1

Recruited

40+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40601321/

Oral Vancomycin for Prevention of Recurrent Clostridioides ... Recurrent CDI occurred in 17 of 39 participants in the oral vancomycin group (43.6%) and 24 of 42 in the placebo group (57.1%; absolute ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835888

Oral Vancomycin for Prevention of Recurrent Clostridioides ... A trial in asymptomatic patients with C difficile colonization found that oral vancomycin was temporarily effective in reducing C difficile ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S266677622400320X

Articles Comparative effectiveness of different therapies for ... This network meta-analysis and systematic review of randomized controlled trials (RCTs) compared all CDI therapies and preventions.

4. cmi-comms.org cmi-comms.org/article/S2950-5909(24)05041-8/fulltext

Oral vancomycin prophylaxis for the prevention of recurrent ... We conducted a systematic review and meta-analysis on the effectiveness and safety of vancomycin prophylaxis versus placebo/no prophylaxis for the prevention ...

5. academic.oup.com academic.oup.com/ofid/article/11/1/ofad622/7462571

Comparative Effectiveness of Fidaxomicin vs Vancomycin in ... The findings of this study suggest that the use of fidaxomicin for treatment of CDI reduces poor outcomes in patients who are immunocompromised.

6. thelancet.com thelancet.com/journals/lanmic/article/PIIS2666-5247(25)00054-0/fulltext

a phase 2b, randomised, double-blind, active-controlled ... In conclusion, ibezapolstat was as clinically effective as vancomycin for the treatment of C difficile infection in adults, showed ideal ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666524725000540

Articles Efficacy, safety, pharmacokinetics, and associated ... This study provides further evidence that vancomycin, although effective at reducing initial clinical symptoms of C difficile infection, has a major disruptive ...

8. academic.oup.com academic.oup.com/cid/article/78/6/1462/7596601

A Randomized, Double-Blind, Phase 3 Safety and Efficacy ... A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile ...