Intestinal Lavage for the Treatment of Severe C. Difficile Infections

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

August 31, 2019

Study Completion Date

August 31, 2019

Conditions
Clostridium Difficile
Interventions
PROCEDURE

Intestinal Lavage

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.

DRUG

Vancomycin

Patients will receive standard antibiotic treatment 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 standard medical care group (active comparator 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.

DRUG

PEG

Polyethylene glycol 3350, 8L in 48 hours, via a nasojejunal tube will be used to facilitate intestinal lavage.

DRUG

Metronidazole

Patients will receive standard antibiotic treatment 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 standard medical care group (active comparator 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.

Trial Locations (1)

N6A 5A5

RECRUITING

London Health Sciences Centre, London

Sponsors
All Listed Sponsors
collaborator

London Health Sciences Centre

OTHER

lead

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER