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Intestinal Lavage for Clostridium Difficile

Phase 2 & 3
Waitlist Available
Led By Tina E Mele, MD PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (>= 18 years) inpatients at LHSC with symptomatic CDI (diarrhea or colonic ileus)
CDI confirmed by standard hospital microbiology lab testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

Clostridium Difficile infections (CDIs) are treated initially with antibiotic therapy and supportive care, with surgical intervention reserved for patients with significant systemic toxicity or perforation. Severe CDI may be refractory to medical management and require surgical intervention, carrying a mortality of approximately 40%. Mortality associated with CDI increases significantly as the severity of the infection increases. In patients failing medical management, earlier operation is associated with decreased mortality. However, the lack of validated tools to predict the necessity for surgical intervention, combined with the significant morbidity associated with total colectomy significantly reduces the likelihood of patients receiving early surgical intervention. The purpose of the proposed study is to assess the addition of intestinal PEG lavage via nasojejunal tube to usual care in the treatment of adult patients with severe CDI who have no immediate indication for surgical intervention.

Eligible Conditions
  • Clostridium Difficile

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of eligible participants recruited into the study
Secondary outcome measures
30-day all-cause mortality
Number of participants meeting study inclusion criteria
Number of participants who complete the assigned study protocol
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intestinal LavageExperimental Treatment4 Interventions
A nasojejunal tube and fecal management system will be inserted. Intestinal lavage with PEG is initiated and increased to a goal rate of 400cc/hour to a total of 8L of PEG. In the absence of an ileus, lavage should be initiated at 200cc/hr. Tolerance is confirmed if the rectal effluent volume is ≥50% of the lavage volume over the first 6 hours and no emesis has developed. If the consulting surgical service suspects a significant ileus, the lavage is initiated at 100cc/hr. If tolerance is confirmed the lavage rate is increased in a stepwise fashion. Antibiotic regimen will consist of Vancomycin 500mg via nasojejunal every 6 hours and Metronidazole 500 mg IV three times daily for 14 days. PEG will be held for 2 hours after administration of Vancomycin.
Group II: Usual CareActive Control2 Interventions
Patients will receive usual care for severe CDI. This includes an antibiotic regimen of Vancomycin 500mg orally every 6 hours and Metronidazole 500mg IV three times daily for 14 days. The usual care group will receive the same antibiotic doses as the experimental arm of the study. For both arms, indications to escalate treatment to surgical intervention will ultimately be based on the clinical assessment by the surgical service. An absolute indication for surgery is perforation. Other indications such as toxic megacolon, worsening peritonitis or biochemical profile lavage are relative indications that vary according to clinician and individual patient characteristics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved
Polyethylene glycol
FDA approved
Metronidazole
FDA approved

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,165 Total Patients Enrolled
London Health Sciences CentreOTHER
141 Previous Clinical Trials
49,398 Total Patients Enrolled
Tina E Mele, MD PhDPrincipal InvestigatorLondon Health Sciences Centre

Frequently Asked Questions

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~2 spots leftby Mar 2025