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Compares treatment options for Central Line Associated Blood Stream Infections (CLABSI)
Official title 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)
ClinicalTrials.gov ID: NCT06822426
What this study is testing
What is (taurolidine and heparin) catheter lock solution?
(taurolidine and heparin) catheter lock solution is an investigational medicine, being studied as a potential treatment for central line associated blood stream infections (clabsi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants who are resident within the US and Türkiye.
- Participants who are male or female, aged ≥18 years at the time of consent.
- Participants must sign and provide informed consent.
- Participants who have a permanent tunneled CVC or permanent peripherally inserted central catheter (PICC) made of silicone or polyurethane, which has...
- Participants who require long-term (\>6 months) TPN based on the investigator assessments.
You likely can't join if
- Any participant unable or not willing to sign inform consent.
- Any participant who has received systemic antibiotic within the last 14 days. Topical antibiotics are permitted. Use of metronidazole or rifaximin...
- Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
- Any participant with temporary, non-tunneled CVC or temporary PICC.
- Any participant that has received thrombolytic treatment (e.g., tissue-type plasminogen activator [tPA]-Cathflo), not as a part of the institution's...
- Any participant with unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.
See the full eligibility criteria
- Participants who are resident within the US and Türkiye.
- Participants who are male or female, aged ≥18 years at the time of consent.
- Participants must sign and provide informed consent.
- Participants who have a permanent tunneled 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.
- Participants who require long-term (\>6 months) TPN based on the investigator assessments.
- Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nutrition (PN).
- Participants who have a minimum of a 4-hour CLS dwelling time and are willing to lock all lumens at a minimum of every 7 days.
- Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment.
- Participants who are able and willing to be trained or have a caregiver who is willing and able to be trained on the instillation, aspiration of DefenCath or heparin, and to maintain a daily diary.
- Male or female participants:
- Women of childbearing potential (WOCBP; see Section 4.5.1) must have a negative pregnancy test at screening (i.e., the participant is not pregnant); not be lactating; and use an acceptable method of contraception...
- Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms with spermicide, even if the male participant has undergone a successful vasectomy (males with...
- Participants who comply with all study procedures and follow-up evaluations.
- Any participant unable or not willing to sign inform consent.
- Any participant who has received systemic antibiotic within the last 14 days. Topical antibiotics are permitted. Use of metronidazole or rifaximin for treating small intestinal bacterial overgrowth (SIBO) is also...
- Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
- Any participant with temporary, non-tunneled CVC or temporary PICC.
- Any participant that has received thrombolytic treatment (e.g., tissue-type plasminogen activator [tPA]-Cathflo), not as a part of the institution's standard of care for patency management, in current catheter within 30...
- Any participant with unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.
- Any participant using any type of antimicrobial-coated or heparin-coated catheter.
- Any participant with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.
- Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.
- Any participant with documented history of an atrial thrombus or known hypercoagulable state.
- Any participant with an open, non-healing skin ulcer.
- Any participant who has received a bone marrow transplant (allogeneic or autogenic/autologous) within the last year.
- Any participant with neutropenia with an absolute neutrophil count \<1000 cells/μL
- Any participant with current requirement for systemic immunosuppression that would increase risk of infection including, but not limited to:
- Steroid use at an equivalent dose of prednisone 20 mg/day anticipated or actual for at least 8 weeks.
- Systemic chemotherapy.
- Methotrexate dose sufficiently high to suppress white blood cell count (WBC) count below 5,000 cells/μL.
- Azathioprine dose greater than 2.5 mg/kg/day.
- Calcineurin inhibitors: i. Cyclosporine dose greater than 8 mg/kg. ii. Tacrolimus dose greater than 0.4 mg/kg. f. Sirolimus dose greater 10 mg/daily.
- Any participant with known allergies or absolute contraindications to citrate, taurolidine, or heparin or a history of heparin-induced thrombocytopenia.
- Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.
- Any participant anticipating receiving a transplant within 90 days. Participants can be on a transplant list but a participant with a known or anticipated transplant date within 90 days of study entry should be excluded...
- Any participant who is pregnant or lactating.
- Any participant receiving continuous TPN (infusion over 24 hours).
- Any participant with any medical conditions that render them unable to, or unlikely to complete the study or would interfere with optimal participation in the study or produce significant risk to participant.
- Any participants who are participating in another treatment clinical study, except for non-pharmacological research studies.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Doral, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
- Sugarland, Texas, United States
- Altındağ, Ankara, Turkey (Türkiye)
- Çankaya, Ankara, Turkey (Türkiye)
- Yenimahalle, Ankara, Turkey (Türkiye)
- Istanbul, Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Doral, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.