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)

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 insertedcentral catheter (PICC) made of silicone or polyurethane, which has been in placefor at least 7 days prior to enrollment.

5. Participants who require long-term (>6 months) TPN based on the investigatorassessments.

6. Participants who require TPN for at least 3 days per week, of which 2 days have tobe parenteral nutrition (PN).

7. Participants who have a minimum of a 4-hour CLS dwelling time and are willing tolock all lumens at a minimum of every 7 days.

8. Participants who are clinically stable, in the opinion of the investigator, for atleast 4 weeks prior to enrollment.

9. Participants who are able and willing to be trained or have a caregiver who iswilling and able to be trained on the instillation, aspiration of DefenCath orheparin, and to maintain a daily diary.

10. Male or female participants:

11. Women of childbearing potential (WOCBP; see Section 4.5.1) must have a negativepregnancy test at screening (i.e., the participant is not pregnant); not belactating; and use an acceptable method of contraception including but notlimited to, abstinence, bilateral tubal ligation, vasectomized partner, abarrier method (diaphragm or condom), Depo-Provera, intrauterine device, orhormonal contraceptive (oral, implant, ring, patch) for the duration of theprogram until at least 30 days after the last DefenCath CLS instillation. (NOTE: The participant must have used the chosen method of birth control for atleast 1 month/cycle prior to enrollment into the study).

12. Male participants who are sexually active with a female partner of childbearingpotential must agree to use male condoms with spermicide, even if the maleparticipant has undergone a successful vasectomy (males with vasectomy can usecondoms without spermicide), from Day 1 until at least 30 days after the lastDefenCath CLS instillation.

13. Participants who comply with all study procedures and follow-up evaluations.

Exclusion Criteria:

1. Any participant unable or not willing to sign inform consent.

2. Any participant who has received systemic antibiotic within the last 14 days.Topical antibiotics are permitted. Use of metronidazole or rifaximin for treatingsmall intestinal bacterial overgrowth (SIBO) is also permitted.

3. Any participant with visible evidence of compromised skin integrity present at thecatheter exist site or catheter exit site infection.

4. Any participant with temporary, non-tunneled CVC or temporary PICC.

5. Any participant that has received thrombolytic treatment (e.g., tissue-typeplasminogen activator [tPA]-Cathflo), not as a part of the institution's standard ofcare for patency management, in current catheter within 30 days of randomization.

6. Any participant with unstable arrhythmia, defined as presence of hemodynamicinstability within a month prior to the baseline assessment.

7. Any participant using any type of antimicrobial-coated or heparin-coated catheter.

8. Any participant with documented chronic bleeding diathesis, active or recurrentbleeding within 1 month prior to randomization.

9. Any participant with a congenitally lethal condition or a life expectancy of lessthan 6 months.

10. Any participant with documented history of an atrial thrombus or knownhypercoagulable state.

11. Any participant with an open, non-healing skin ulcer.

12. Any participant who has received a bone marrow transplant (allogeneic orautogenic/autologous) within the last year.

13. Any participant with neutropenia with an absolute neutrophil count <1000 cells/μL

14. Any participant with current requirement for systemic immunosuppression that wouldincrease risk of infection including, but not limited to:

15. Steroid use at an equivalent dose of prednisone 20 mg/day anticipated or actualfor at least 8 weeks.

16. Systemic chemotherapy.

17. Methotrexate dose sufficiently high to suppress white blood cell count (WBC)count below 5,000 cells/μL.

18. Azathioprine dose greater than 2.5 mg/kg/day.

19. Calcineurin inhibitors: i. Cyclosporine dose greater than 8 mg/kg. ii. Tacrolimus dose greater than 0.4mg/kg. f. Sirolimus dose greater 10 mg/daily.

20. Any participant with known allergies or absolute contraindications to citrate,taurolidine, or heparin or a history of heparin-induced thrombocytopenia.

21. Any participant taking other medication with known systemic drug interaction withcitrate, taurolidine or heparin.

22. Any participant anticipating receiving a transplant within 90 days. Participants canbe on a transplant list but a participant with a known or anticipated transplantdate within 90 days of study entry should be excluded from study participation. Aparticipant who may receive a transplant >90 days of study entry may remain on thestudy as long as they continue to receive TPN.

23. Any participant who is pregnant or lactating.

24. Any participant receiving continuous TPN (infusion over 24 hours).

25. Any participant with any medical conditions that render them unable to, or unlikelyto complete the study or would interfere with optimal participation in the study orproduce significant risk to participant.

26. Any participants who are participating in another interventional clinical study,except for non-pharmacological research studies.