ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
Recruiting
Brigham and Women's Hospital
Phase 2
2020-01-01
This is a randomized controlled trial to assess the clinical and microbiological impacts of
FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in
patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection
(CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary
care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in
combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be
obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides
hospitals with screened, filtered, and frozen material ready for clinical use. Patients will
be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as
well as clinical data will be collected at baseline, week 1, 8 and 12.
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
Recruiting
Merck Sharp & Dohme Corp.
Phase 4
2019-08-30
This study will examine whether the human monoclonal antibody, bezlotoxumab administered
AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent
antibiotic therapy, will eliminate the high risk of C. diff relapse.
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
Recruiting
Montefiore Medical Center
Phase 4
2019-08-30
This study will examine whether the human monoclonal antibody, bezlotoxumab administered
AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent
antibiotic therapy, will eliminate the high risk of C. diff relapse.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
