Overview

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

Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cefepime
Penicillanic Acid
Piperacillin
Piperacillin, Tazobactam Drug Combination
Tazobactam
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