NCT02466698

A Feasibility Randomized Trial of Intestinal Lavage for the Treatment of Severe C. Difficile Infections

Status unknown Phase 2/Phase 3 Last updated 9 August 2018

What this trial tests

Phase 2/Phase 3 trial testing Intestinal Lavage in Clostridium Difficile in 20 participants. Status unknown.

Timeline

1 August 2016

Primary endpoint
1 August 2019

1 August 2019

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 August 2016
Primary completion	1 August 2019
Estimated completion	1 August 2019
Sites	1 location across Canada

Drugs / interventions tested

• Intestinal Lavage
• Vancomycin (vancomycin) — full drug profile →
• PEG
• Metronidazole (METRONIDAZOLE) — full drug profile →

Conditions studied

• Clostridium Difficile — all drugs for Clostridium Difficile →

Sponsor

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

Who can join

18 and older, any sex, with Clostridium Difficile. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of eligible participants recruited into the study
  Time frame: 12 months
  Recruited participants

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe <i>Clostridium difficile</i> colitis: a randomised controlled pilot study.
   McCreery G, Jones PM, Kidane B, DeMelo V, et al · · 2017 · cited 5× · PMID 28760801 · DOI 10.1136/bmjopen-2017-016803