RecruitingPhase 3NCT06822426

Comparing 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)

A Phase 3, Prospective, Multicenter, Double-Blind, Randomized, Controlled, Adaptive Study To Demonstrate The Safety And Efficacy Of DEFENCATH® In Reducing Central Line-Associated Bloodstream Infections (CLABSIs) In Adult Participants Receiving Total Parenteral Nutrition (TPN) Via Central Venous Catheter (CVC)

Sponsor

CorMedix

Enrollment

200 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Central Line Associated Blood Stream Infections (CLABSI)

Summary

This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called (taurolidine and heparin) catheter lock solution and a drug called Heparin for people with central line associated blood stream infections (clabsi). The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG(taurolidine and heparin) catheter lock solution

for central venous catheter installation use

DRUGHeparin

Heparin

Locations(22)

University of California Los Angeles

Los Angeles, California, United States

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

Bioresearch Partner

Doral, Florida, United States

Emory University Hospital - GCRC

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Iowa Health Care

Iowa City, Iowa, United States

Johns Hopkins Clinical Research Unit

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Duke University Hospital

Durham, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Vanderbilt Center for Human Nutrition

Nashville, Tennessee, United States

Alchemi - Sugarland

Sugarland, Texas, United States

Hacettepe University Hospitals

Altındağ, Ankara, Turkey (Türkiye)

Ankara University Ibni Sina Research and Application Hospital

Çankaya, Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Hacettepe University Hospitals

Yenimahalle, Ankara, Turkey (Türkiye)

Istanbul University Faculty of Medicine, Capa State Hospital

Istanbul, Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06822426

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