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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2026-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Intestinal Microbiome Febrile Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Piperacillin-tazobactam

Group Type ACTIVE_COMPARATOR

Piperacillin-tazobactam

Intervention Type DRUG

piperacillin-tazobactam (4.5 gm IV q 6 hrs)

cefepime

Group Type EXPERIMENTAL

cefepime

Intervention Type DRUG

(2 gm IV q 8 hrs)

Interventions

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Piperacillin-tazobactam

piperacillin-tazobactam (4.5 gm IV q 6 hrs)

Intervention Type DRUG

cefepime

(2 gm IV q 8 hrs)

Intervention Type DRUG

Eligibility Criteria

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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 with history of infection with extended-spectrum beta-lactamase producing organism. Patients known to be colonized with multi-drug resistant gram-negative organisms or with history of infection with multi-drug resistant organisms will be evaluated case by case and discussed with infectious disease specialist before enrollment
* Febrile patients
* Patients with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No