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Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)

22 de septiembre de 2026 actualizado por: CorMedix Therapeutics

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 And Adolescent Participants Receiving Total Parenteral Nutrition (TPN) Via Central Venous Catheter (CVC)

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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • Fase 3

Acceso ampliado

Ya no está disponible fuera del ensayo clínico. Ver registro de acceso ampliado.

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Liz Hurlburt, Chief Clinical Strategy & Operations Officer
  • Número de teléfono: 908-517-9500
  • Correo electrónico: lhurlburt@cormedix.com

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90024
        • Reclutamiento
        • University of California Los Angeles
        • Contacto:
        • Contacto:
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Reclutamiento
        • MedStar Health Research Institute
        • Contacto:
        • Contacto:
    • Florida
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Emory University Hospital - GCRC
        • Contacto:
          • Thomas R Ziegler, MD
          • Número de teléfono: 404-727-7351
          • Correo electrónico: tzieg01@emory.edu
        • Contacto:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
      • Maywood, Illinois, Estados Unidos, 60153
        • Reclutamiento
        • Loyola University Medical Center
        • Contacto:
        • Contacto:
          • Maria Chavez
          • Número de teléfono: 464-220-9498
          • Correo electrónico: mchavez11@luc.edu
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • Reclutamiento
        • University of Iowa Health Care
        • Contacto:
        • Contacto:
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Reclutamiento
        • Johns Hopkins Clinical Research Unit
        • Contacto:
          • Sara Keller, MD, MPH, MSHP
          • Número de teléfono: 410-952-7572
          • Correo electrónico: Skeller9@jhmi.edu
        • Contacto:
          • Marwa El-Ashry, BS
          • Número de teléfono: 667-306-9370
          • Correo electrónico: melashr1@jh.edu
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198-3285
        • Reclutamiento
        • University of Nebraska Medical Center
        • Contacto:
          • David F Mercer, MD, PhD, FRCS(C)
          • Número de teléfono: 402-559-6955
          • Correo electrónico: dmercer@unmc.edu
        • Contacto:
          • Rachel Harper, RN, BSN
          • Número de teléfono: 402-559-1282
          • Correo electrónico: raharper@unmc.edu
    • New York
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • Columbia University Irving Medical Center
        • Contacto:
        • Contacto:
      • New York, New York, Estados Unidos, 10029
      • New York, New York, Estados Unidos, 10016
        • Aún no reclutando
        • NYU Grossman School of Medicine
        • Contacto:
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Retirado
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Reclutamiento
        • Cleveland Clinic Foundation
        • Contacto:
        • Contacto:
          • Jessica Sosio, DO
          • Número de teléfono: 216-442-2416
          • Correo electrónico: sosioj@ccf.org
    • Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Reclutamiento
        • Rhode Island Hospital
        • Contacto:
        • Contacto:
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37212-1150
        • Reclutamiento
        • Vanderbilt Center for Human Nutrition
        • Contacto:
        • Contacto:
    • Texas
      • Sugarland, Texas, Estados Unidos, 77478
        • Reclutamiento
        • Alchemi - Sugarland
        • Contacto:
        • Contacto:
  • Turquía (Türkiye)
    • Ankara
      • Altındağ, Ankara, Turquía (Türkiye), 06230
        • Reclutamiento
        • Hacettepe University Hospitals
        • Contacto:
          • Prof. Dr. Meltem Gulhan Halil
          • Número de teléfono: (90) 532 786 45 35
          • Correo electrónico: meltemhalil@yahoo.com
        • Contacto:
      • Yenimahalle, Ankara, Turquía (Türkiye), 06560
        • Reclutamiento
        • Hacettepe University Hospitals
        • Contacto:
        • Contacto:
          • Assoc. Prof. Dr. Kamil Inci
          • Número de teléfono: (90) 544 212 25 45
          • Correo electrónico: kamilinci@gmail.com
      • Çankaya, Ankara, Turquía (Türkiye), 06800
        • Reclutamiento
        • Ankara Bilkent City Hospital
        • Contacto:
          • Prof. Dr. Mutlu Doganay
          • Número de teléfono: (90) 532 295 60 50
          • Correo electrónico: drmdoganay@gmail.com
        • Contacto:
      • Çankaya, Ankara, Turquía (Türkiye), 06230
        • Reclutamiento
        • Ankara University Ibni Sina Research and Application Hospital
        • Contacto:
        • Contacto:
    • Istanbul
      • Istanbul, Istanbul, Turquía (Türkiye), 34093
        • Reclutamiento
        • Istanbul University Faculty of Medicine, Capa State Hospital
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

  1. Participants who are resident within study site's country.

  2. Participants who are male or female, aged ≥12 years at the time of consent.

  3. Participants must sign and provide informed consent. For adolescent participants or participants that require a legal representative, written informed consent will be obtained from the study participant's legal guardian or legal representative and the assent from the participant when applicable. All legal guardians and representatives should be fully informed, and participants should be informed to the fullest extent possible about the study using language and terms they are able to understand.

  4. Participants who have a tunneled/non-tunneled CVC or 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 (>3 Months) TPN based on the investigator assessments.

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

  7. 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.

  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 instillation, aspiration of DefenCath or heparin, and to maintain a daily diary.

    Male or female participants:

  10. 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/cycle prior to enrollment into the study).

  11. 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.

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

Exclusion Criteria:

  1. Any participant unable or not willing to sign inform consent or, in the case of adolescents, not willing to provide assent.
  2. Any participant who is currently receiving systemic antibiotics. Topical antibiotics are permitted. Use of metronidazole or rifaximin for treating small intestinal bacterial overgrowth (SIBO) is also permitted.
  3. Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
  4. Any participant with a secondary CVC in addition to the primary TPN line.
  5. 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.
  6. Any participant with unstable arrhythmia, defined as presence of hemodynamic instability 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 recurrent bleeding within 1 month prior to randomization.
  9. Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.
  10. Any participant with documented history of an atrial thrombus or known hypercoagulable state.
  11. Any participant with an open, non-healing skin ulcer.
  12. Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
  13. Any participant with neutropenia with an absolute neutrophil count <500 cells/μL
  14. Any participant with current requirement for systemic chemotherapy and or immunosuppression and absolute neutrophil count <500 cells/μL that occured in the past 4 weeks.
  15. Any participant with known allergies or absolute contraindications to citrate, taurolidine, pork products, or heparin or a history of heparin-induced thrombocytopenia.
  16. Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.
  17. Any participant anticipating receiving an intestinal 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 an intestinal transplant >90 days of study entry may remain on the study as long as they continue to receive TPN.
  18. Any participant who is pregnant or lactating.
  19. Any participant receiving continuous TPN (infusion over 24 hours).
  20. 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.
  21. Any participants who are participating in another interventional clinical study or planning/anticipating participating in another interventional clinical study, except for non-pharmacological research studies.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
Droga: Heparin

Heparin
Experimental: DefenCath®
Droga: (taurolidine and heparin) catheter lock solution

for central venous catheter installation use

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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, but fail to complete the 12-month follow-up period of the study.
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)
Periodo de tiempo: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Compare the safety profile of DefenCath for use as a Catheter Lock Solution (CLS) in adult and adolescent participants receiving Total Parenteral Nutrition (TPN) through a Central Venous Catheter (CVC) to the control of heparin CLS
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)
Incidence of changes in laboratory evaluations, vital signs, or physical exam findings
Periodo de tiempo: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Compare the safety profile of DefenCath for use as a CLS in adult and adolescent participants receiving TPN through a CVC to the control of heparin CLS
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CorMedix Therapeutics

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de mayo de 2025

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

15 de enero de 2025

Primero enviado que cumplió con los criterios de control de calidad

6 de febrero de 2025

Publicado por primera vez (Actual)

12 de febrero de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NUTRI-GUARD

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Sharibg if protocol and ICF, pending FDA approval of this indication

Marco de tiempo para compartir IPD

Pending FDA Approval

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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