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Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant

Primary Purpose

Intestinal Microbiome, Febrile Neutropenia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Piperacillin-tazobactam
cefepime
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Microbiome focused on measuring Antibiotic, piperacillin-tazobactam, cefepime, aztreonam, 17-097

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with any hematologic malignancy undergoing

Exclusion Criteria:

  • Patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin. Severe reactions include anaphylaxis and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).
  • Patients with unconfirmed allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin can be evaluated by an Allergy/Immunology specialist, after which they may become eligible by a consensus of the treating physician, trial investigator and and the Allery
  • Prolonged antibiotic treatment ( ≥10 days, within 3 weeks of enrollment) as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing anti anaerobic antibiotics
  • Patients known to be colonized with multi-drug resistant organisms or with history of infection with multi-drug resistant organisms. Patients with history of infection with extended-spectrum beta-lactamase producing organism.
  • Febrile patients
  • Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Sites / Locations

  • Hackensack Meridian HealthRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Piperacillin-tazobactam

cefepime

Arm Description

Outcomes

Primary Outcome Measures

measurement of fold-change in Clostridiales abundance
Fold change will be assessed 7 +/- 2 days after initiating antibiotic treatment for febrile neutropenia and will be compared to the pre-treatment specimen. Pre-treatment stool specimen will be collected between the time of enrollment Patients will be enrolled and infusion of allografts or first episode of neutropenic fever, whichever occurs first.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2017
Last Updated
August 9, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03078010
Brief Title
Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant
Official Title
Rational Use of Broad-spectrum Antibiotics as Empiric Antibiotic Therapy in Febrile Neutropenia in Recipients of Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

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.
Yes

5. Study Description

Brief Summary
The purpose of this study is to see how different antibiotics affect the community of friendly bacteria existing in the intestinal tract (gut). Under normal circumstances, these friendly bacteria are not harmful and they help with normal bodily functions such as digestion. When these bacteria are absent, several complications may occur, such as infections with harmful bacteria or other inflammatory reactions, that can complicate the stem cell transplant course. Treatment with antibiotics or chemotherapy is known to kill off these friendly bacteria. In this study we compare the effects of different antibiotics on the community of friendly bacteria in the gut. For microbiota-related biomarker analysis, optional urine samples (MSKCC patients only) will be collected at baseline, 7 +/-2 days after initiation of antibiotic therapy, and on post-transplant days +28, +56 and +100 (+/- 7days).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Microbiome, Febrile Neutropenia
Keywords
Antibiotic, piperacillin-tazobactam, cefepime, aztreonam, 17-097

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized open-label phase II study to assess the association between antibiotic treatment strategies and the change in the relative abundance of Clostridiales.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piperacillin-tazobactam
Arm Type
Active Comparator
Arm Title
cefepime
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Piperacillin-tazobactam
Intervention Description
piperacillin-tazobactam (4.5 gm IV q 6 hrs)
Intervention Type
Drug
Intervention Name(s)
cefepime
Intervention Description
(2 gm IV q 8 hrs)
Primary Outcome Measure Information:
Title
measurement of fold-change in Clostridiales abundance
Description
Fold change will be assessed 7 +/- 2 days after initiating antibiotic treatment for febrile neutropenia and will be compared to the pre-treatment specimen. Pre-treatment stool specimen will be collected between the time of enrollment Patients will be enrolled and infusion of allografts or first episode of neutropenic fever, whichever occurs first.
Time Frame
7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Patients with any hematologic malignancy undergoing Exclusion Criteria: Patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin. Severe reactions include anaphylaxis and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Patients with unconfirmed allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin can be evaluated by an Allergy/Immunology specialist, after which they may become eligible by a consensus of the treating physician, trial investigator and and the Allery Prolonged antibiotic treatment ( ≥10 days, within 3 weeks of enrollment) as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing anti anaerobic antibiotics Patients known to be colonized with multi-drug resistant organisms or with history of infection with multi-drug resistant organisms. Patients with history of infection with extended-spectrum beta-lactamase producing organism. Febrile patients Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boglarka Gyurkocza, MD
Phone
212-639-2860
Email
ABMTTrials@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Seo, MD
Email
ABMTTrials@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boglarka Gyurkocza, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Donato, MD
Phone
551-996-8297
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boglarka Gyurkocza, MD
Email
ABMTTrials@mskcc.org
First Name & Middle Initial & Last Name & Degree
Susan Seo, MD
Email
ABMTTrials@mskcc.org

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant

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