NCT06822426 · CorMedix
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)
What this study is about
This is a Phase 3, randomly assigned, where neither patients nor doctors know which treatment is given, controlled, adaptive, 2-treatment group$1, conducted at multiple hospitals study to demonstrate the effectiveness and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.
View original scientific description
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.
Interventions
DRUG
(taurolidine and heparin) catheter lock solution
for central venous catheter installation use
DRUG
Heparin
Heparin
Primary outcome measures
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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants who are resident within the US. 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 Central Venous Catheter (CVC) or permanent peripherally inserted central catheter (PICC) made of silicone or polyurethane, which has been in place for at least 7 days prior to enrollment. 5. Participants who require long term (\>6 months) Total Parenteral Nutrition (TPN) based on the investigator assessments. 6. Participants who require TPN for at least 3 days per week. 7. Participants who have a minimum of a 4-hour Catheter Lock Solution (CLS) dwelling time and are willing to lock all lumens at a minimum of every 7 days. 8. Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment. 9. Participants who are able and willing to be trained or have a caregiver who is willing and able to be trained on the in
Where
- Los Angeles, California
- Washington D.C., District of Columbia
- Doral, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
- Baltimore, Maryland
- Rochester, Minnesota
- Omaha, Nebraska
- New York, New York
- Durham, North Carolina
- Cleveland, Ohio
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations