A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia
Categories (click each to see list of all clinical trials associated with that category): Child Health Research Institute (CHRIONC), Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Eligibility: https://clinicaltrials.gov/study/NCT07022678?term=NCT07022678&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To compare the incidence rate of bloodstream infections (BSI) (BSI per 1000 patient-days) from oral organisms over 2 cycles of chemotherapy in children with acute myeloid leukemia (AML) randomized to xylitol-containing oral wipes (xylitol dental wipes) versus control wipes.
SECONDARY OBJECTIVE:
I. To compare the rate of BSI (BSI per 1000 patient-days) from any organism in patients randomized to xylitol dental wipes versus control wipes.
EXPLORATORY OBJECTIVES:
I. To compare the frequency of severe infection (defined as any infection or infestation falling under Common Terminology Criteria for Adverse Events [CTCAE] sepsis grade 4 or 5) in patients randomized to xylitol dental wipes versus control wipes.
II. To compare the frequency of fever and neutropenia episodes in patients randomized to xylitol dental wipes versus control wipes.
III. To compare the frequency of severe mucositis, using the Children's International Mucositis Evaluation Scale (ChIMES), in patients randomized to xylitol dental wipes versus control wipes in addition to CTCAE grade 3 and above mucositis.
IV. To evaluate changes in oral microbial composition in pediatric patients treated with xylitol versus control wipes.