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catheter lock

Phase 3

Central Line Associated Blood Stream Infections (CLABSI) | Small molecule | Other |CorMedix Inc.|Last Updated: May 20, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06822426Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)PHASE3 RECRUITING 200 — — May 14, 2025Jan 1, 2028May 20, 202622 United States, Turkey (Türkiye)
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Study Endpoints
Primary Endpoints
Comparison between treatment groups of proportion of participants who experience a Central Line-Associated Bloodstream Infections (CLABSI) within 12 months of the start of the study
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

The proportion of participants who remain infection-free in the treatment groups will be compared, censoring participants who do not experience a CLABSI within 9 months, but fail to complete the 12 month follow-up period of the study.

Secondary Endpoints
Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)
Incidence of changes in laboratory evaluations, vital signs, or physical exam findings
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
DefenCath®EXPERIMENTAL -
ControlACTIVE_COMPARATOR -
Interventions
NameTypeDescription
(taurolidine and heparin) catheter lock solutionDRUGfor central venous catheter installation use
HeparinDRUGHeparin
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

1. Participants who are resident within the US and Türkiye. 2. Participants who are male or female, aged ≥18 years at the time of consent. 3. Participants must sign and provide informed consent. 4. Participants who have a permanent tunneled CVC or permanent peripherally inserted central catheter (PI...

Countries:United StatesTurkey (Türkiye)
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06822426primaryCompletionDate: changed
LOWMay 24, 2026NCT06822426studyFirstPostDate: changed