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Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Study acronym: TRIPS
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: May 15, 2027 to May 15, 2028
    • Study completion date: Aug 31, 2027 to Aug 31, 2028
    • Site contacts updated at 6 of 32 sites
    v10
  2. Study sites: 29 to 32v9
  3. Study sites: 27 to 29
    • Eligibility criteria shortened, about 10 words
    v8
  4. Study sites: 24 to 27v7
  5. Study sites: 25 to 24v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Jun 8, 2022 to Jun 14, 2022
    • Site details revised at 5 of 25 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 15, 2022 to Jun 8, 2022
    • Site details revised at 25 of 25 sites
    v4
  3. Start date: Mar 15, 2022 to May 15, 2022
    • Primary completion date: Mar 15, 2027 to May 15, 2027
    v3
  4. Primary endpoint revised
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).
Trial Details
NCT Number NCT05267821
Lead Sponsor Nationwide Children's Hospital
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov