search
Back to results

Bezlotoxumab Efficacy and Tolerability in Cancer Patient

Primary Purpose

Clostridium Difficile Infection Recurrence

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bezlotoxumab Injection
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Historical control

    Arm Description

    Recruited patient according inclusion/exclusion criteria

    Cohort of historical patients matched to study population to serve as control

    Outcomes

    Primary Outcome Measures

    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).
    Documentation of recurrent CDI infection

    Secondary Outcome Measures

    Determine if bezlotoxumab infusion add-on treatment is cost saving in patients with malignancies in terms of preventing CDI recurrence.
    Pharmacoeconomic analysis

    Full Information

    First Posted
    June 1, 2020
    Last Updated
    June 1, 2020
    Sponsor
    The Cooper Health System
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04415918
    Brief Title
    Bezlotoxumab Efficacy and Tolerability in Cancer Patient
    Official Title
    Is Bezlotoxumab Effective, Tolerable and Cost Saving in Preventing Recurrent Clostridium Difficile Infections in Patients With Malignancies? An Exploratory Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Cooper Health System

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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 of Helsinki. Approval of Institutional Review Board at Cooper Health Care will be obtained prior to commencing the study and actively enrolled patients will sign an informed consent form. Data will be collected on a case report form and confidentiality will be protected according to laws and regulations. Study population will include adult cancer patients diagnosed with CDI being treated at MD Anderson cancer center affiliated with Cooper University Hospital, Camden, NJ, USA. The comparison arm will be a historical group of patients treated at the same center with same inclusion/exclusion criteria within the previous 3 years of start date. Recruited patients will receive a single dose of Bezlotoxumab (Zinplava) 10mg/kg (actual body weight) 60-minute intravenous infusion during active CDI treatments. For pharmacoeconomic analysis, data collected from the financial department will include total hospitalization costs, drug costs, length of stay, total amount charged and total amount reimbursedpertaining to CDI diagnosis code/ICD-10 for recurrent CDI. The analysis will encompass the perspectives of the hospital and the third party payer. Adjustment of retrospective cost data will be performed using Medical Consumer Price index (MCPI) inflation rates established by Bureau of Labor Statistics. Cost-avoidance analysis will be performed to determine the cost of preventing recurrence. Incremental cost-effectiveness ratio (ICER) defined as the difference in cost divided by difference in outcomes will be reported. The outcome being examined, the percent of recurrences avoided, will be used in the denominator. Graphically, a cost-effectiveness plane will be used to depict the comparison. Secondary analyses will examine specific differences between groups, including total drug costs, length of stay (LOS) and per diem hospitalization costs. Univariate sensitivity analyses will be conducted to determine robustness of the analysis. Matching of intervention group with control will be based on inclusion/exclusion criteria, sex, and GEIH-CDI propensity score as shown in the table below. Matching will be in the ratio of 1:2. Selected historical control based on inclusion/exclusion criteria will matched to same sex. Patients treated at MD Anderson cancer center affiliated with Cooper University Hospital Camden, NJ, USA with diagnosis of CDI will be screened using inclusion/exclusion criteria. Eligible patients will be approached for consent. Recruited patients will receive the study intervention either as in-patients or at the out-patient infusion unit according to their current status. The study patients will be followed for 12 weeks (day1 is the day of study intervention) on week1, week2, week 4, week 8 and week 12 (- or + 5 days) until study exit day. Study required clinical data will be collected from medical records on case report form. Financial data will be acquired from accounting department records. Recruited patients will be interviewed on the phone or in person. Study intervention drug will be stored at the Pharmacy Department, Cooper University Hospital. Shortly before the time of administration, infusion will be prepared as per manufacturer instructions (250 mL infused over 1 hours through 0.22-micron sterile filter controlled by volumetric pump) and transported for administration per the hospital protocol. Patients receiving bezolotoxumab infusion will be under observation and follow up as per study protocol. To assess recurrence, clinical cure is achieved in patients receiving standard of care treatment and have no diarrhea (< 3 bowel movements per day) for 2 consecutive days following completion of therapy. Patients will be followed by reviewing medical records, in person and by phone. Tolerability of bezolotoxumab will be assessed by collecting clinical and laboratory data about adverse events as detailed below under adverse experience reporting. A 10-mL blood sample will be collected from patients in heparinized tubes (processed and/or stored as required by the lab) for genetic DNA profiling. An an assessment of bezlotoxumab efficacy and the correlation with the SNP will be performed. Withdrawal from the study will be voluntary or at the discretion of investigators/sponsor in case of tolerability concerns, protocol violation or any other reason.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile Infection Recurrence

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Recruited patient according inclusion/exclusion criteria
    Arm Title
    Historical control
    Arm Type
    No Intervention
    Arm Description
    Cohort of historical patients matched to study population to serve as control
    Intervention Type
    Drug
    Intervention Name(s)
    Bezlotoxumab Injection
    Other Intervention Name(s)
    No intervention
    Intervention Description
    A single dose of Bezlotoxumab (Zinplava) 10mg/kg (actual body weight) 60-minute intravenous infusion during active CDI treatments.
    Primary Outcome Measure Information:
    Title
    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).
    Description
    Documentation of recurrent CDI infection
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Determine if bezlotoxumab infusion add-on treatment is cost saving in patients with malignancies in terms of preventing CDI recurrence.
    Description
    Pharmacoeconomic analysis
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    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.
    Description
    Genetic analysis is performed to describe gene type
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 -

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be shared

    Learn more about this trial

    Bezlotoxumab Efficacy and Tolerability in Cancer Patient

    We'll reach out to this number within 24 hrs