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ACTIVE NOT RECRUITING
NCT03078010
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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).

Official title: Rational Use of Broad-spectrum Antibiotics as Empiric Antibiotic Therapy in Febrile Neutropenia in Recipients of Allogeneic Hematopoietic Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

347

Start Date

2017-02-10

Completion Date

2027-02

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Piperacillin-tazobactam

piperacillin-tazobactam (4.5 gm IV q 6 hrs)

DRUG

cefepime

(2 gm IV q 8 hrs)

Locations (2)

Hackensack Meridian Health

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States