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Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 22 to 24
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study title expanded, about 3 words
  2. Sponsor changed: CorMedix to CorMedix Therapeutics
    • Site details revised at 6 of 22 sites
    v14
  3. Site details revised at 4 of 22 sitesv13
  4. Site details revised at 1 of 22 sitesv12
  5. Primary and study completion dates: Jan 2027 to Jan 2028
    • Study sites: 15 to 22
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 14 to 15v10
  2. Site contacts updated at 10 of 14 sitesv9
  3. Study sites revised (14)v8
  4. Study sites: 11 to 14
    • Eligibility criteria expanded, about 42 words
    v7
  5. Study sites: 7 to 11v6
  6. Study sites: 5 to 7v5
  7. Enrollment target: 140 to 200
    • Eligibility criteria shortened, about 8 words
    v4
  8. Study sites: 1 to 5v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2025 to May 14, 2025
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult and adolescent participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.
Trial Details
NCT Number NCT06822426
Lead Sponsor CorMedix Therapeutics
Conditions
(from sponsor)		 Central Line Associated Blood Stream Infections (CLABSI)
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov