[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CorMedix\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100579294","phase-3-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-100579294",false,"NCT06822426","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)","1. Participants who are resident within the US and Türkiye.\n2. Participants who are male or female, aged ≥18 years at the time of consent.\n3. Participants must sign and provide informed consent.\n4. 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.\n5. Participants who require long-term (\\>6 months) TPN based on the investigator assessments.\n6. Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nutrition (PN).\n7. 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.\n8. Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment.\n9. 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.\n10. Male or female participants:\n\n    1. 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 including but not limited to, abstinence, bilateral tubal ligation, vasectomized partner, a barrier method (diaphragm or condom), Depo-Provera, intrauterine device, or hormonal contraceptive (oral, implant, ring, patch) for the duration of the program until at least 30 days after the last DefenCath CLS instillation. (NOTE: The participant must have used the chosen method of birth control for at least 1 month\u002Fcycle prior to enrollment into the study).\n    2. 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 vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last DefenCath CLS instillation.\n11. Participants who comply with all study procedures and follow-up evaluations.\n\nExclusion Criteria:\n\n1. Any participant unable or not willing to sign inform consent.\n2. 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 permitted.\n3. Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.\n4. Any participant with temporary, non-tunneled CVC or temporary PICC.\n5. 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 days of randomization.\n6. Any participant with unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.\n7. Any participant using any type of antimicrobial-coated or heparin-coated catheter.\n8. Any participant with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.\n9. Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.\n10. Any participant with documented history of an atrial thrombus or known hypercoagulable state.\n11. Any participant with an open, non-healing skin ulcer.\n12. Any participant who has received a bone marrow transplant (allogeneic or autogenic\u002Fautologous) within the last year.\n13. Any participant with neutropenia with an absolute neutrophil count \\\u003C1000 cells\u002FμL\n14. Any participant with current requirement for systemic immunosuppression that would increase risk of infection including, but not limited to:\n\n    1. Steroid use at an equivalent dose of prednisone 20 mg\u002Fday anticipated or actual for at least 8 weeks.\n    2. Systemic chemotherapy.\n    3. Methotrexate dose sufficiently high to suppress white blood cell count (WBC) count below 5,000 cells\u002FμL.\n    4. Azathioprine dose greater than 2.5 mg\u002Fkg\u002Fday.\n    5. Calcineurin inhibitors:\n\n    i. Cyclosporine dose greater than 8 mg\u002Fkg. ii. Tacrolimus dose greater than 0.4 mg\u002Fkg. f. Sirolimus dose greater 10 mg\u002Fdaily.\n15. Any participant with known allergies or absolute contraindications to citrate, taurolidine, or heparin or a history of heparin-induced thrombocytopenia.\n16. Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.\n17. 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 from study participation. A participant who may receive a transplant \\>90 days of study entry may remain on the study as long as they continue to receive TPN.\n18. Any participant who is pregnant or lactating.\n19. Any participant receiving continuous TPN (infusion over 24 hours).\n20. 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.\n21. Any participants who are participating in another interventional clinical study, except for non-pharmacological research studies.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.",[26],"Central Line Associated Blood Stream Infections (CLABSI)","RECRUITING","2026-05-18",{"date":30,"type":31},"2026-05-20","ACTUAL",{"date":33,"type":31},"2025-05-14",{"date":35,"type":20},"2028-01",{"name":37,"class":38},"CorMedix","INDUSTRY",22,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100571024","phase-4-open-label-study-to-assess-safety-and-time-to-catheter-related-bloodstream-infections-crbsi-in-subjects-from-birth-to--18-years-of-age-100571024","NCT06714864","Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to \u003C 18 Years of Age","An Open-Label, Two-Arm (DefenCath® vs. Institutional Standard of Care) Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to Less Than 18 Years of Age With Kidney Failure Receiving Hemodialysis Via a Central Venous Catheter","Inclusion Criteria:\n\n* All participants must be \\\u003C 18 years of age and must meet the following inclusion criteria:\n* The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.\n* A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the schedule of activities (SoA) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant during the scheduled study visits; accurately and reliably dispense study intervention as directed.\n* The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.\n* The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.\n* The participant has demonstrated the ability to achieve an appropriate minimum blood flow (Qb) for the participant's relative age and weight for at least 2 consecutive dialysis sessions to enable successful HD.\n* The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.\n* The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.\n* The participant is receiving adequate HD as assessed by the investigators and based on a single pool Kt\u002FV measurement \\> 1.2 (within the last 40 days).\n* The participant is not expected to expire within 180 days, based on clinical assessment.\n* Female participants of childbearing potential:\n* Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last administration of study treatment.\n* Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last administration of study treatment:\n* True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post ovulation methods\\] and withdrawal are not acceptable).\n\nCombined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.\n\n* Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.\n* Bilateral tubal occlusion\u002Fligation.\n* Intrauterine device.\n* Intrauterine hormone releasing system.\n* Vasectomized partner.\n* NOTE: If the childbearing potential changes after start of the study (e.g., a premenarchal female participant experiences menarche) or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception, or a male participant must use a condom. If reproductive status is questionable, additional evaluation should be considered.\n* Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms and spermicide, even if the male participant has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last administration of study treatment.\n\nExclusion Criteria:\n\n* The participant has received systemic antibiotics within the last 14 days. Topical antibiotic use is permitted.\n* Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.\n* The participant has received any thrombolytic treatment (i.e., tissue plasminogen activator \\[tPA\\] - Cathflo®), not as part of the institution's standard of care for patency management, in their current catheter within 30 days of randomization.\n* The fill volume of catheter lumen(s) is unknown or cannot be determined.\n* The participant uses any type of antimicrobial-coated or heparin-coated catheter.\n* Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.\n* Documented history of an atrial thrombus or known hypercoagulable state.\n* The participant has open, non-healing skin ulcers.\n* Current requirement for systemic immunosuppression that would increase risk of infection, such as:\n* High dose steroid. Low-dose steroids, such as routinely used for maintenance of organ transplants, are acceptable.\n* Methotrexate dose sufficiently high to suppress white blood cells (WBC) below 5,000 cells\u002FµL.\n* Biologic immunomodulators (anti-tumour necrosis factor, anti-CD4 antibody, etc.) within 30 days.\n* Azathioprine.\n* Calcineurin inhibitors (dose determined by investigator).\n* Sirolimus.\n* An active malignancy that either in and of itself or by virtue of its treatment with chemotherapy or biologic therapy results in neutropenia, leukopenia and\u002For immunosuppression.\n* Known allergy or absolute contraindication to taurolidine, citrate, or heparin, or a history of heparin induced thrombocytopenia (HIT).\n* Unstable malignancy.\n* Cirrhosis with encephalopathy.\n* The participant is currently taking another medication with known systemic drug interaction with taurolidine, citrate, or heparin.\n* The participant is anticipated to receive a renal transplant within 90 days (participants can be on the transplant list, but a participant with a known or anticipated transplant date within the next 90 days should be excluded).\n* The participant has a clinically significant cardiac rhythm or functional disorder.\n* The participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension prior to randomization based on assessment of the investigator.\n* Any other medical condition which renders the participant unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the participant.","17 Years",{"count":49,"type":20},36,[51],"PHASE4","This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.",[54],"Catheter-Related Infections","2026-05-15",{"date":57,"type":31},"2026-05-19",{"date":59,"type":31},"2025-07-08",{"date":61,"type":20},"2029-04",{"name":37,"class":38},6,""]