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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. Identifier: NCT03078010
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : March 4, 2019
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 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 2020
Estimated Study Completion Date : February 2020

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)

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with any hematologic malignancy undergoing either an unmodified allogeneic HCT or a double umbilical cord blood transplant with or without the infusion of T-cell depleted HLA-haploidentical peripheral blood stem cells.
  • Patients undergoing an umodified transplant must have a related or unrelated marrow or peripheral blood stem cell (PBSC) donor as follows:

A. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and HLA-DRB1 at high resolution using DNA-based typing B. Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing.

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
  • Patients receiving post-transplant cyclophosphamide as GVHD prophylaxis

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 identifier (NCT number): NCT03078010

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Contact: Boglarka Gyurkocza, MD 212-639-2860
Contact: Susan Seo, MD 212-639-3151

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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Boglarka Gyurkocza, MD    212-639-2860      
Contact: Susan Seo, MD    212-639-3151      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Boglarka Gyurkocza, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT03078010     History of Changes
Other Study ID Numbers: 17-097
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019

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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:

Additional relevant MeSH terms:
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Febrile Neutropenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Piperacillin, Tazobactam Drug Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action