Intestinal Lavage for the Treatment of Severe C. Difficile Infections

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: London Health Sciences Centre
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Metronidazole; Polyethylene glycol 3350; Vancomycin

Criteria

Inclusion Criteria:

• Adult (>= 18 years) inpatients at LHSC with symptomatic CDI (diarrhea or colonic ileus)

• CDI confirmed by standard hospital microbiology lab testing

• Patients must meet criteria for severe CDI, defined as either: white blood cell > 15,000 or Serum Creatinine > 1.5 times the pre-morbid level

• Patients must have at least one additional risk factor for severity:

i. Fever >38.5 (if no other source of fever suspected) ii. Vasopressor requirement iii. Mechanical ventilation requirement iv. Serum lactate >5 mmol/L v. Colonic distension (>6cm transverse colon diameter on abdominal Xray or CT) vi. Colonic wall thickening, on abdominal Xray or CT, as reported by radiology. vii. Calculated ATLAS score ≥ 4

Exclusion Criteria:

• The patient is deemed to have an immediate indication for surgery related to the diagnosis of CDI by the on call General Surgery service.

• Pre-existing bowel discontinuity (e.g. ileostomy).

• General Surgery service or most responsible care team deem the patient to have a contraindication to nasojejunal tube or fecal management system

• Patients anticipated to be intolerant of the study regimen (e.g. severe ileus, unable to tolerate oral intake, etc.)