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NCT05579639 · ClinicalTrials.gov registry record · Phase 2

Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

A Phase 2 study of Allogeneic Stem Cell Transplantation, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
Phase 2
Development phase
419
Enrollment target
3
Study locations

NCT05579639: Recruiting Phase 2 study of Allogeneic Stem Cell Transplantation, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT05579639 is a Phase 2 study of Allogeneic Stem Cell Transplantation that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 419 participants, above the 58-participant average among 3 other Allogeneic Stem Cell Transplantation trials with a reported enrollment target (622% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05579639, a Phase 2 study of Allogeneic Stem Cell Transplantation, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
Phase 2
Development phase
419 participants
Enrollment target
3
Study locations

Study Summary

Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.

Primary Outcome

Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo

Interventions

  • OTHER Placebo
  • OTHER Xylitol

Study Locations (3)

Colorado

  • Children's Hospital Colorado - Aurora

Massachusetts

  • Dana-Farber/Boston Children's - Boston

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 419 participants
Start Date 2023-04-04
Est. Completion 2027-06-30
Phase Phase 2

What NCT05579639 shows while recruiting

NCT05579639 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, above the 58-participant average among 3 other Allogeneic Stem Cell Transplantation trials with a reported enrollment target (622% higher).

The record links to 1 condition, with Allogeneic Stem Cell Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05579639 reports a single indexed study location in Colorado, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT05579639 about?

NCT05579639 is a clinical study titled "Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant". Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable populatio...

What is the current status of trial NCT05579639?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 419 participants. The study started on 2023-04-04. Estimated completion is 2027-06-30.

What conditions does trial NCT05579639 study?

This clinical trial studies the following conditions: Allogeneic Stem Cell Transplantation.

What interventions are being tested in trial NCT05579639?

The interventions under investigation include: Placebo (OTHER), Xylitol (OTHER).

Who is sponsoring clinical trial NCT05579639?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05579639 being conducted?

This trial has 3 study locations across Colorado, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05579639, the US trial registry maintained by the National Library of Medicine. NCT05579639 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.