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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05579639
The ClinicalTrials.gov registry entry for NCT05579639 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 419 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 58-participant average among 3 other Allogeneic Stem Cell Transplantation trials with a reported enrollment target (622% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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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Related
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