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

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: NCT03078010
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Intestinal Microbiome Febrile Neutropenia Drug: Piperacillin-tazobactam Drug: cefepime Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Rational Use of Broad-spectrum Antibiotics as Empiric Antibiotic Therapy in Febrile Neutropenia in Recipients of Allogeneic Hematopoietic Cell Transplantation
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Piperacillin-tazobactam Drug: Piperacillin-tazobactam
piperacillin-tazobactam (4.5 gm IV q 6 hrs)
Experimental: cefepime Drug: cefepime
(2 gm IV q 8 hrs)


Outcome Measures
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Primary Outcome Measures :
  1. measurement of fold-change in Clostridiales abundance [ Time Frame: 7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime ]
    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.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078010


Contacts
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Contact: Boglarka Gyurkocza, MD 212-639-2860 ABMTTrials@mskcc.org
Contact: Susan Seo, MD ABMTTrials@mskcc.org

Locations
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United States, New Jersey
Hackensack Meridian Health Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Michele Donato, MD    551-996-8297      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Boglarka Gyurkocza, MD       ABMTTrials@mskcc.org   
Contact: Susan Seo, MD       ABMTTrials@mskcc.org   
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Boglarka Gyurkocza, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03078010    
Other Study ID Numbers: 17-097
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022

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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.: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
Antibiotic
piperacillin-tazobactam
cefepime
aztreonam
17-097
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Hyperthermia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Heat Stress Disorders
 Wounds and Injuries
Tazobactam
Piperacillin
Cefepime
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action