Bezlotoxumab Efficacy and Tolerability in Cancer Patient

NCT04415918 | Unknown Phase 4 FDA Drug

• 1 other identifier: 20-432
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Clostridium Difficile Infection Recurrence

Outcome Measures

Primary Outcomes (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).

  Documentation of recurrent CDI infection

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Other Outcomes (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.

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Recruited patient according inclusion/exclusion criteria

Drug: Bezlotoxumab Injection

Historical control

NO INTERVENTION

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

Interventions

Bezlotoxumab Injection DRUG

A single dose of Bezlotoxumab (Zinplava) 10mg/kg (actual body weight) 60-minute intravenous infusion during active CDI treatments.

Also known as: No intervention

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

MeSH Terms

Interventions

bezlotoxumab

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share