Optimal Treatment for Recurrent Clostridium Difficile
Stopped: The study sponsor stopped the trial early after enrolling 308 of the target sample size because of a slower than expected recruitment rate.
United States308 participantsStarted 2016-02-19
Plain-language summary
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent obtained and signed
* Age \> 18
* If female, participant must not be pregnant or nursing
* Negative pregnancy test required for females \<61 years of age or without prior hysterectomy
* Confirmed current diagnosis of CDI, determined by having
* \>3 loose or semi-formed stools for participants over 24 hours AND
* Positive stool assay for C. difficile
* EIA positive for toxin A/B; or
* Cytotoxin assay; or
* Nucleic Acid Amplification Test (NAAT, PCR or LAMP) based detection of toxigenic C. difficile
* Current episode represents the first recurrent episode of CDI within 3 months of the primary CDI episode in a patient who has not had CDI in the 3 months prior to the primary episode OR a second recurrent CDI episode occurring within 3 months of the first recurrent episode, as defined above
* At least one of the previous CDI episodes must have been confirmed by a stool assay for C. difficile
Exclusion Criteria:
* Inability to provide informed consent
* Inability to take oral capsules
* Receipt of \>72 hours of antibiotics considered effective in the treatment of CDI, including:
* metronidazole
* vancomycin
* fidaxomicin
* nitazoxanide
* rifaximin
* Prior infusion of bezlotoxumab within the previous 6 months
* Known presence of fulminant CDI, including hypotension, severe ileus or GI obstruction or incipient toxic megacolon
* Receipt of more than a single course of oral vancomycin, fidaxomicin, or a vancomycin ta…
What they're measuring
1
Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens