A Randomized Pilot Study Comparing Infection Rates in Myeloablative Allogeneic Stem Cell Transplant Patients Receiving a Non-Neutropenic Diet or a Neutropenic Diet
In the proposed pilot study, a randomized design will be used to address the primary and
secondary aims. Subjects will be randomized to either the experimental group receiving a
non-neutropenic diet without restriction, or to the control group receiving the standard
neutropenic diet. While randomization will occur prior to, or on the day of their inpatient
admission and the subjects will begin study procedures upon admission to the Adult Stem Cell
Transplant Inpatient Unit at Duke University Medical Center.
The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged
from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient
Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize
the opportunity for deviation from the assigned diet. Absence of neutropenia will be defined
as an absolute neutrophil count of greater than 500/uL (manual differential) and a total
white blood cell count of 1000/uL for three consecutive days.
All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other
supportive care will also be consistent in the two groups.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Incidence of Bacteremia
Participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will be measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks.
Duration of hospitalization or neutropenia, an expected average of 5 weeks.
Nelson Chao, MD, MBA
Duke University School of Medicine
United States: Institutional Review Board
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