Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | February 10, 2017 |
| End Date: | February 2020 |
| Contact: | Boglarka Gyurkocza, MD |
| Email: | gyurkocb@mskcc.org |
| Phone: | 212-639-2860 |
Rational Use of Broad-spectrum Antibiotics as Empiric Antibiotic Therapy in Febrile Neutropenia in Recipients of Allogeneic Hematopoietic Cell Transplantation
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.
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.
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-2860
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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