Status:
UNKNOWN
Bezlotoxumab Efficacy and Tolerability in Cancer Patient
Lead Sponsor:
The Cooper Health System
Conditions:
Clostridium Difficile Infection Recurrence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Investigation of efficacy and tolerability of bezlotoxumab in patients with cancer diagnosis in terms of preventing CDI recurrence.
Detailed Description
The study will be prospective, open-label, single center with historical control. All procedures will be conducted according to Good Clinical Practice guidelines and the provisions of the Declaration ...
Eligibility Criteria
Inclusion
- Patients \> 18 years of age
- Diagnosed with any type of malignancy and receiving active treatment (chemotherapy, radiotherapy or biological therapy)
- Confirmed clinical (patients with unexplained and new-onset \>3 unformed stools in 24 hours) and laboratory (a stool toxin test as part of a multistep algorithm) diagnosis of primary or recurrent CDI and receiving standard of care treatment
- Patient or legally authorized person signs informed consent form -
Exclusion
- 1- Patients with short life expectancy including terminal cancer, multi-organ dysfunction or on compassionate care (as per treating physician) 2- Pregnant or breastfeeding female patients or likely to be pregnant without negative laboratory confirmation 3- Patients with active chronic diarrheal disease 4- Patients with other acute, unstable and life-threatening conditions (acute renal or hepatic failure, sepsis or other severe infections, active bleeding, stroke or myocardial infarction) 5- Patient receiving or planning to receive other CDI interventions like FMT within 3 months of bezlotuxumab therapy 6- Patients who previously received bezlotoxumab within the past 3 months 7- Patients completed active of CDI treatment 8- Patients with any conditions that at discretion of the investigators will compromise patient rights, ability to participate or complete the study
- \-
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04415918
Start Date
July 1 2020
End Date
December 31 2021
Last Update
June 4 2020
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