Use Of Oral Fidaxomicin Vs. Oral Vancomycin For Clostridium Difficile Infection In Patients With Spinal Cord Injury
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Clostridium Difficile, Spinal Cord Injury
In brief
The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall costs of treatment of Clostridium difficile infection in the two study groups.
Key facts
- Study ID
- NCT02355938
- Run by
- Baylor College of Medicine
- People needed
- 12
- Starts
- 2014-02-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability of subject to provide an informed consent
- Legally Authorized Representative-Adult must provide consent in case the subject is unable to consent
- Diagnosis of Clostridium difficile disease based on clinical manifestations (change in bowel habits, at least 2 more unformed bowel movements as compared to baseline neurogenic bowel function in the same patient in the 24-hour period prior to randomization)
- Lab data (positive polymerase chain reaction test for Clostridium difficile in a stool specimen obtained within 72 hours before randomization)
- Patient has not received antibiotics that are active against Clostridium difficile for any more than 24 hours prior to being screened for this study.
You may not qualify if…
- Receipt of agents (oral Vancomycin, oral or IV Metronidazole, oral rifamdin, oral bacitracin, or oral fusidic acid) that are active against Clostridium difficile for longer than 24 hours after randomization
- Life-threatening or fulminant Clostridium difficile infection, presence of toxic megacolon, and history of inflammatory bowel disease (Crohn's disease and ulcerative colitis)
- Allergy to study medications.
Where it is running
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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