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Bezlotoxumab Efficacy and Tolerability in Cancer Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415918
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

Brief Summary:
Investigation of efficacy and tolerability of bezlotoxumab in patients with cancer diagnosis in terms of preventing CDI recurrence.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Recurrence Drug: Bezlotoxumab Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is Bezlotoxumab Effective, Tolerable and Cost Saving in Preventing Recurrent Clostridium Difficile Infections in Patients With Malignancies? An Exploratory Study
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Recruited patient according inclusion/exclusion criteria
Drug: Bezlotoxumab Injection
A single dose of Bezlotoxumab (Zinplava) 10mg/kg (actual body weight) 60-minute intravenous infusion during active CDI treatments.
Other Name: No intervention

No Intervention: Historical control
Cohort of historical patients matched to study population to serve as control



Primary Outcome Measures :
  1. The proportion of patients with recurrent CDIs within 12 weeks of initial cure compared with historical group of patients selected with same inclusion/exclusion criteria (same center within 3 years of the start date of the study). [ Time Frame: 12 weeks ]
    Documentation of recurrent CDI infection


Secondary Outcome Measures :
  1. Determine if bezlotoxumab infusion add-on treatment is cost saving in patients with malignancies in terms of preventing CDI recurrence. [ Time Frame: 12 weeks ]
    Pharmacoeconomic analysis


Other Outcome Measures:
  1. Explore if genetic variants (SNP rs2516513 on xMHC, SNP genotype on IL-8 gene promotor, SNP rs2243250 IL-4 gene,….) are associated with increased recurrence of CDI in this patient population. [ Time Frame: 12 weeks ]
    Genetic analysis is performed to describe gene type



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients > 18 years of age
  2. Diagnosed with any type of malignancy and receiving active treatment (chemotherapy, radiotherapy or biological therapy)
  3. 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
  4. Patient or legally authorized person signs informed consent form -

Exclusion Criteria:

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

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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT04415918    
Other Study ID Numbers: 20-432
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Clostridium Infections
Enterocolitis, Pseudomembranous
Recurrence
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases