Clinical Trials Logo

Clinical Trial Summary

Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to need for removal of the entire colon or even death. In fact, mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted mortality rate is 14% for severe infection. It is believed that the failure of treatment may stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin functions by direct contact with the colon. Therefore, if the vancomycin is instilled directly into the colon, it can come into contact with and be its intended target. : The objective of the study is to improve treatment of severe C. diff. colitis . C. diff. infection is defined as severe if there is evidence of ileus accompanied by any one of the following: fever greater than 38.30C, , acidemia, serum albumin less than 2.5, or white blood cell count greater than 14,000.


Clinical Trial Description

Patients in the surgical intensive care unit with severe C. diff. are eligible and if consented will be randomized in a 1:1 ratio to a control group or the treatment group. Each group will undergo a colonoscopy on day one of the study. A 14 French Cook colonic decompression catheter will be placed at that time. This catheter is a 175cm long soft flexible catheter designed to be placed in the colon. Its usual use is to remove air from a colon that is dilated. The catheter is placed into the colon by first placing a guidewire through the colonoscope. The colonoscope is then removed leaving the guidewire in place. The catheter is then thread into the colon over the guidewire. An xray is obtained to confirm the location of the catheter and then the guidewire is removed. The guidewire is a very thin, soft, flexible wire. The patient will not have any undue discomfort secondary to the catheter. The control group will have 250cc of sterile saline solution instilled through the catheter into the colon every 6 hours. The study group will have 250cc of vancomycin solution instilled every 6 hours. The solution will be 2 grams vancomycin dissolved in a 1 liter normal saline irrigation bottle. The catheter will be clamped in both groups after instillation until the next treatment. Of note, both groups will receive the current standard treatment of 500mg IV metronidazole every 8 hours and 250mg oral vancomycin every 6 hours throughout the study. Every day the patients will have a blood draw to check the white blood cell count as is the current practice. The patients will also have a vancomycin trough level checked via blood test. This will occur just prior to the first dosing on treatment day number 3. This will be a blinded lab value as to not unblind the investigators. At resolution Patients will undergo a repeat colonoscopy when there is a decrease of diarrhea (less than 3 stools daily) and a normalized white blood cell count or on day 7 if symptoms persist. The expected length of treatment is approximately 7 days. If there is no improvement at fourteen days, the trial will be stopped for futility. The trial will also be halted if the attending physician determines that the patient needs surgery or if the clinical status of the patient has deteriorated to a point where keeping the patient enrolled will potentially cause harm. Follow-up after completing the trial will consist of phone interviews to screen for recurrence of infection. A weekly phone call will be made for the first three weeks and then two monthly calls will take place after that for a total of three months follow-up. The primary investigator will make these phone calls. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01346059
Study type Interventional
Source William Beaumont Hospitals
Contact
Status Terminated
Phase N/A
Start date April 2011
Completion date February 2012

See also
  Status Clinical Trial Phase
Completed NCT00272818 - Study to Identify Non-Invasive Markers of Gastrointestinal Allergy
Completed NCT01369355 - A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) Phase 3
Completed NCT02709213 - Determination of the Aetiologies of Acute Colitis and Early Identification of Patients Requiring Diagnostic Colonoscopy
Completed NCT00533078 - Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies Phase 2
Terminated NCT00184171 - Treatment of Microscopic Colitis N/A
Recruiting NCT05333978 - Optoacoustic Detection of Inflammation Using MSOT Device N/A
Not yet recruiting NCT06424769 - Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management N/A
Recruiting NCT02768038 - Intestinal Microbiome and Chronic Inflammatory Bowel Disease
Recruiting NCT04272307 - MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.
Completed NCT05514561 - FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms
Completed NCT00072943 - A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease Phase 2
Recruiting NCT02687724 - Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis Phase 4
Completed NCT02647866 - Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis Phase 2
Completed NCT01326013 - A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel Phase 2
Not yet recruiting NCT05726396 - A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis Phase 2
Completed NCT05414552 - ECP for Immune-related Adverse Events After Checkpoint Inhibitor Treatment
Recruiting NCT04407247 - Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma Phase 1/Phase 2
Completed NCT01369329 - A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) Phase 3
Completed NCT01369342 - A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) Phase 3
Terminated NCT00936585 - NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease N/A