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

StatusTerminated
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: At the recommendation of the DSMB, the study was halted following an interim futility analysis, which determined that continued enrollment would not alter the study outcome. Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati · Eligibility criteria expanded, about 11 words · Site details revised at 3 of 3 sites Show 3 more changesShow less
    • Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati
    • Eligibility criteria expanded, about 11 words
    • Site details revised at 3 of 3 sites
  2. Primary completion pushed from Jul 5, 2026 to Sep 11, 2026v13
  3. Enrollment reduced: 419 → 256 participants Trial status changed: Recruiting → Active, Not Recruiting · Primary completion moved earlier from Apr 30, 2027 to Jul 5, 2026 · Completion moved earlier from Jun 30, 2027 to Sep 11, 2026 · 1 morev12 Show 4 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Apr 30, 2027 to Jul 5, 2026
    • Completion moved earlier from Jun 30, 2027 to Sep 11, 2026
    • Site details revised at 3 of 3 sites
  4. Primary completion pushed from Mar 31, 2026 to Apr 30, 2027v11
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study description expanded, about 1 wordv9 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date: Mar 2026 to Mar 31, 2026 Completion date: Jun 2027 to Jun 30, 2027v8 Show 1 more changeShow less
    • Completion date: Jun 2027 to Jun 30, 2027
  3. Study sites: 2 to 3v7
  4. Study sites: 1 to 2v6
  5. Start date changed from estimate of Mar 2023 to Apr 4, 2023v5
  6. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  7. Start date: Feb 2023 to Mar 2023v3
  8. Start date: Nov 2022 to Feb 2023 Primary completion date: Dec 2026 to Mar 2026 · Completion date: Mar 2027 to Jun 2027v2 Show 2 more changesShow less
    • Primary completion date: Dec 2026 to Mar 2026
    • Completion date: Mar 2027 to Jun 2027
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05579639
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Conditions Allogeneic Stem Cell Transplantation
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov