drugset / Trial / NCT02466698

Intestinal Lavage for the Treatment of Severe C. Difficile Infections

NCT02466698

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2016-08
Primary completion
2019-08
Completion
2019-08

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG Unknown 8000 ml Other
Background Metronidazole Small molecule 500 mg Intravenous
Background Vancomycin Other / unclassified 500 mg Oral