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Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Study acronym: DOMINIC
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 25, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2025 Study sites: 32 to 33 · Completion date: Dec 31, 2024 to Dec 31, 2026v8 Show 2 more changesShow less
    • Study sites: 32 to 33
    • Completion date: Dec 31, 2024 to Dec 31, 2026
  2. Eligibility criteria expanded, about 36 words Site details revised at 2 of 32 sitesv7 Show 1 more changeShow less
    • Site details revised at 2 of 32 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024 Study sites: 27 to 32v6 Show 1 more changeShow less
    • Study sites: 27 to 32
  4. Lead sponsor: Duke University to Arkansas Children's Hospital Research Institute Primary endpoints revised (8) · Study sites: 22 to 27 · Interventions: Non-Invasive Testing for PIMI (Diagnostic Test) to Non-Invasive Testing for PIFI (Diagnostic Test) · 2 morev5 Show 5 more changesShow less
    • Primary endpoints revised (8)
    • Study sites: 22 to 27
    • Interventions: Non-Invasive Testing for PIMI (Diagnostic Test) to Non-Invasive Testing for PIFI (Diagnostic Test)
    • Eligibility criteria revised
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023 Study sites: 11 to 22v4 Show 1 more changeShow less
    • Study sites: 11 to 22
Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria expanded, about 34 words Site details revised at 3 of 11 sitesv3 Show 1 more changeShow less
    • Site details revised at 3 of 11 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Secondary endpoints: details revised at 1 of 1 entryv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
Trial Details
NCT Number NCT03827694
Lead Sponsor Arkansas Children's Hospital Research Institute
Collaborators: Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov