Vancomycin for C.diff Infection

Overseen By Brian Phan, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Riverside University Health System Medical Center

Must not be taking: Metronidazole, Probiotics

Disqualifiers: Pregnancy, Incarceration, CDI history, others

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

Compensation: Varies

Number of Visits: 33

Duration: Up to 26 days

176 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

I am an adult who has been given antibiotics for over 72 hours during my hospital stay.

I am over 65, have lived in a care facility, used proton pump inhibitors, have inflammatory bowel disease, am immunocompromised, have end-stage renal disease, diabetes, received high-dose catecholamines, was hospitalized recently or received antibiotics in hospital.

Exclusion Criteria

Allergic reaction or had a contraindication for use of enteral vancomycin

Pregnant or breastfeeding women

Currently incarcerated individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 26 days

Monitored every 3 days until hospital discharge

Follow-up

Participants are contacted via telephone to assess for diarrhea or any untoward effects of the study medication.

Up to 4 months

Telephonic surveys at 30 and 90 days post-discharge

Extension/Long-term follow-up

Participants are monitored for community-onset healthcare facility-associated CDI via telephonic surveys.

Up to 90 days

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?

Group I: Oral Vancomycin 125 mg (liquid) Active Control 1 Intervention

Oral Vancomycin 125 mg (liquid) daily

Group II: Placebo oral (liquid) Placebo Group 1 Intervention

Oral Placebo (liquid) daily.

Who Is Running the Clinical Trial?

Riverside University Health System Medical Center

Lead Sponsor

Trials

10

Recruited

19,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07221370

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 ...

2. 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 ...

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

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 ...

4. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00320-X/fulltext

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).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10039659/

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 ...

6. cdc.gov cdc.gov/c-diff/about/index.html

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 ...

7. aafp.org aafp.org/pubs/afp/issues/2020/0201/p168.html

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).

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 ...