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Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin

NCT01226992 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2014-12-08

No results posted yet for this study

Summary

Recurrent CDI is a growing problem with few treatment options that provide lasting effect. Fecal transplantation has been shown in several case series to be successful in controlling recurrent CDI. The current study is a non-blinded, randomized controlled trial comparing fecal transplantation with a 6 week taper of oral vancomycin for the treatment of refractory CDI. Approximately 146 patients will be enrolled over one year. Participants in the study will be followed for 120 days, and will be given the opportunity to cross over to the alternative intervention arm if a relapse in symptoms occurs. The primary outcome measure will be recurrence of toxin-confirmed CDI within 120 days of starting the intervention. Secondary outcomes include: early recurrence of symptoms within 14 days, relapse within 120 days (same strain of C. difficile), attributable mortality, hospitalization and serious adverse events.

Conditions

  • Recurrent Clostridium Difficile Infection
  • Laboratory Confirmed Clostridium Difficile Infection

Interventions

DRUG

Vancomycin

Oral Vancomycin: Dose: 125 mg po qid x 2 weeks then 125 mg po bid x 1 week then 125 mg po od x 1 week then 125 mg po q every other day x 1 week then 125 mg po q every third day x 1 week then discontinue Route: oral

BIOLOGICAL

Fecal Transplant

Fecal slurry 50 grams stool in 500ml normal saline

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Susy Hota, MD FRCPC · Infectious Disease, Infection Prevention and Control, Epidemiologist

  • Susan Poutanen, MD MPH FRCPC · Infectious Disease, Microbiologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226992 on ClinicalTrials.gov