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NCT07022678 · ClinicalTrials.gov registry record · Phase 3
Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
A Phase 3 study, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 556
- Enrollment target
NCT07022678: Recruiting Phase 3 study, sponsored by Children's Oncology Group.
NCT07022678 is a Phase 3 study that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 556 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07022678, a Phase 3 study, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 556 participants
- Enrollment target
Study 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.
Primary Outcome
Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Best Practice
- OTHER Electronic Health Record Review
- DRUG Cytarabine
- DRUG Placebo Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2026-05-26 |
| Est. Completion | 2033-01-15 |
| Phase | Phase 3 |
What NCT07022678 shows while recruiting
NCT07022678 is an interventional study that assigns participants to a tested intervention. The registered 556 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07022678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07022678 about?
NCT07022678 is a clinical study titled "Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia". 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 t...
What is the current status of trial NCT07022678?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 556 participants. The study started on 2026-05-26. Estimated completion is 2033-01-15.
What interventions are being tested in trial NCT07022678?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Best Practice (OTHER), Electronic Health Record Review (OTHER), Cytarabine (DRUG), Placebo Administration (DRUG).
Who is sponsoring clinical trial NCT07022678?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07022678's enrollment target sits among peer trials
556 675th of 2000 higher than 1,325 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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