RecruitingPhase 3NCT07022678

Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia

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


Sponsor

Children's Oncology Group

Enrollment

556 participants

Start Date

May 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.


Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Best Practice, a procedure called Biospecimen Collection, and others for people with acute myeloid leukemia and recurrent acute myeloid leukemia. The study is currently recruiting participants at 24 locations. People eligible for this study include aged 1 Year to 25 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Given standard chemotherapy

PROCEDUREBiospecimen Collection

Undergo saliva sample collection

DRUGCytarabine

Given IV

OTHERElectronic Health Record Review

Ancillary studies

DRUGPlacebo Administration

Given intraorally

OTHERXylitol-containing Oral Wipe

Given intraorally


Locations(28)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Valley Children's Hospital

Madera, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Albany Medical Center

Albany, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07022678


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