Vancomycin for C.diff Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether oral vancomycin can prevent C.diff, a common and potentially dangerous gut infection, in critically ill hospital patients. The study compares the effects of vancomycin with a placebo to determine if it reduces the risk of C.diff infection. It also examines vancomycin's impact on the presence of C.diff in the body and its safety for patients. Suitable candidates for this trial include those hospitalized for at least three days, taking strong antibiotics, and having conditions like diabetes or a weakened immune system (such as those with HIV/AIDS or undergoing chemotherapy). Participants will take the study medication while hospitalized and may continue after discharge if necessary. As a Phase 2, Phase 3 trial, this study evaluates vancomycin's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving metronidazole or probiotics. It's best to discuss your current medications 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 safe and well-tolerated by patients. Clinical trials have found that most people taking oral vancomycin did not experience major side effects. While it effectively treats certain C.diff infections, its preventive ability remains under investigation. Health guidelines already recommend this medication for other C.diff treatments, indicating a known safety record. Prospective trial participants can take comfort in knowing that many patients have used oral vancomycin safely. Always consult a healthcare provider to determine if it's appropriate.12345
Why do researchers think this study treatment might be promising?
Most treatments for C. diff infection involve antibiotics like metronidazole, fidaxomicin, or oral vancomycin tablets. However, researchers are excited about using oral vancomycin in liquid form because it may offer better absorption and more precise dosing compared to tablets. This liquid formulation could potentially provide a more effective and faster response in combating the infection. Additionally, by having a liquid form, it may be easier for some patients to take, especially those who have difficulty swallowing pills.
What evidence suggests that oral vancomycin might be an effective treatment for preventing C.diff infection?
Studies have shown that oral vancomycin can help prevent C.diff (Clostridioides difficile) infections, particularly in high-risk individuals. This trial will provide participants with either oral vancomycin or a placebo. One study found that people taking vancomycin experienced fewer repeat infections compared to those on a placebo. Specifically, 43.6% of people on vancomycin had a recurrence, while 57.1% of those on a placebo did. However, some research suggests that while vancomycin is beneficial, it might not be as effective as other treatments like fidaxomicin. Overall, vancomycin has been shown to help manage C.diff, but its effectiveness can vary.12678
Are You a Good Fit for This Trial?
This trial is for critically ill adults at high risk of C.diff infection due to hospitalization and underlying medical conditions. Participants must be willing to take oral vancomycin or a placebo alongside systemic antibiotics, provide stool samples, and continue medication after discharge if needed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral vancomycin or placebo while on systemic antibiotics, continuing for up to five days after the last dose of antibiotics, not exceeding 21 days.
Follow-up
Participants are contacted via telephone to assess for diarrhea or any untoward effects of the study medication.
Extension/Long-term follow-up
Participants are monitored for community-onset healthcare facility-associated CDI via telephonic surveys.
What Are the Treatments Tested in This Trial?
Interventions
- Enteral Vancomycin
Trial Overview
The study tests whether oral vancomycin can prevent C.diff infections in high-risk patients compared to a placebo. It involves taking the drug during and possibly after hospital treatment with antibiotics, monitoring carrier status, and assessing any changes in the gut microbiome.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Oral Vancomycin 125 mg (liquid) daily
Oral Placebo (liquid) daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Riverside University Health System Medical Center
Lead Sponsor
Citations
Enteral Vancomycin as Primary Prophylaxis Against ...
The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at ...
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 ...
Articles Comparative effectiveness of different therapies for ...
Of the antibiotics, fidaxomicin showed the most favorable outcomes, whereas vancomycin and metronidazole exhibited lower efficacy. FMT was positioned within the ...
a systematic review and network meta-analysis of ...
In recurrent cases, fidaxomicin (P-score: 0.6734) showed significantly greater effectiveness than vancomycin (P-score: 0.3677) and tolevamer (P-score: 0.0365).
The Clinical Efficacy, Safety, and Tolerability of ...
The resolution of infection varied from 19% to 58.3% in five of six studies reporting this as an outcome. Four out of six studies reported new ...
About C. diff
Any time antibiotics are used, they can cause side effects, including C. diff infection. Take antibiotics only when you need them. Talk to a ...
Clostridioides difficile Infection: Update on Management
The 2017 IDSA guidelines recommend oral vancomycin or fidaxomicin (Dificid) for treatment of nonsevere initial C. difficile infection (Table 4).
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 ...
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