vancomycin for Clostridium Difficile (C. diff) Infection

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Clostridium Difficile (C. diff) InfectionVancomycin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether giving vancomycin to patients who are already colonized with C. diff will prevent them from getting CDI when they are admitted to the hospital for another infection.

Eligible Conditions
  • Clostridium Difficile (C. diff) Infection

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 4 years

4 years
The incidence of CDI in inpatients receiving vancomycin prophylaxis vs. placebo who are on high-risk antibiotics and are colonized with toxigenic C. difficile.
Antibiotics
The outcome of CDI in patients receiving vancomycin prophylaxis vs. placebo.
The prevalence of toxigenic C. difficile colonization among the inpatient population treated with high-risk antibiotics based on C. difficile PCR.
The severity of CDI in patients receiving vancomycin prophylaxis vs. placebo.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

vancomycin
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

2500 Total Participants · 2 Treatment Groups

Primary Treatment: vancomycin · Has Placebo Group · Phase 4

vancomycin
Drug
ActiveComparator Group · 1 Intervention: Vancomycin · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor
142 Previous Clinical Trials
111,928 Total Patients Enrolled
Matthew Sims, MD PhDPrincipal InvestigatorBeaumont Health
2 Previous Clinical Trials
141 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who are initiating treatment with one of the following antibiotics within the prior 72 hours and have an expected duration of treatment of at least 72 hours from enrollment are eligible for the study: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin.
The maximum expected duration of antibiotics is 8 weeks.
This text is saying that a person is able to provide a stool sample during their hospitalization or within three days of discharge.
The person is expected to be able to complete follow up.