TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
Status:
Completed
Trial end date:
2021-01-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the risks and benefits of antibiotic treatment for
Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid
amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Currently, healthcare facilities use a wide variety of tests and strategies for identifying
patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for
identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive
EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI
if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI;
while this treatment is standard of care at many facilities, the risk and benefits of
treating these patients for CDI is unknown.
We propose to perform a double blinded, randomized controlled non-inferiority trial of
antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and
benefits of CDI treatment in this population.