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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 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Fase 3

Accesso esteso

Non più disponibile al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Liz Hurlburt, Chief Clinical Strategy & Operations Officer
  • Numero di telefono: 908-517-9500
  • Email: lhurlburt@cormedix.com

Luoghi di studio

  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90024
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20010
    • Florida
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Emory University Hospital - GCRC
        • Contatto:
        • Contatto:
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
      • Maywood, Illinois, Stati Uniti, 60153
        • Reclutamento
        • Loyola University Medical Center
        • Contatto:
        • Contatto:
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • Reclutamento
        • University of Iowa Health Care
        • Contatto:
        • Contatto:
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21205
        • Reclutamento
        • Johns Hopkins Clinical Research Unit
        • Contatto:
          • Sara Keller, MD, MPH, MSHP
          • Numero di telefono: 410-952-7572
          • Email: Skeller9@jhmi.edu
        • Contatto:
          • Marwa El-Ashry, BS
          • Numero di telefono: 667-306-9370
          • Email: melashr1@jh.edu
    • Minnesota
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198-3285
        • Reclutamento
        • University of Nebraska Medical Center
        • Contatto:
          • David F Mercer, MD, PhD, FRCS(C)
          • Numero di telefono: 402-559-6955
          • Email: dmercer@unmc.edu
        • Contatto:
    • New York
      • New York, New York, Stati Uniti, 10032
        • Reclutamento
        • Columbia University Irving Medical Center
        • Contatto:
        • Contatto:
      • New York, New York, Stati Uniti, 10029
      • New York, New York, Stati Uniti, 10016
        • Non ancora reclutamento
        • NYU Grossman School of Medicine
        • Contatto:
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Ritirato
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Reclutamento
        • Cleveland Clinic Foundation
        • Contatto:
        • Contatto:
          • Jessica Sosio, DO
          • Numero di telefono: 216-442-2416
          • Email: sosioj@ccf.org
    • Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Reclutamento
        • Rhode Island Hospital
        • Contatto:
        • Contatto:
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37212-1150
        • Reclutamento
        • Vanderbilt Center for Human Nutrition
        • Contatto:
        • Contatto:
    • Texas
      • Sugarland, Texas, Stati Uniti, 77478
  • Turchia (Türkiye)
    • Ankara
      • Altındağ, Ankara, Turchia (Türkiye), 06230
        • Reclutamento
        • Hacettepe University Hospitals
        • Contatto:
        • Contatto:
      • Yenimahalle, Ankara, Turchia (Türkiye), 06560
        • Reclutamento
        • Hacettepe University Hospitals
        • Contatto:
        • Contatto:
          • Assoc. Prof. Dr. Kamil Inci
          • Numero di telefono: (90) 544 212 25 45
          • Email: kamilinci@gmail.com
      • Çankaya, Ankara, Turchia (Türkiye), 06800
        • Reclutamento
        • Ankara Bilkent City Hospital
        • Contatto:
        • Contatto:
      • Çankaya, Ankara, Turchia (Türkiye), 06230
        • Reclutamento
        • Ankara University Ibni Sina Research and Application Hospital
        • Contatto:
        • Contatto:
    • Istanbul
      • Istanbul, Istanbul, Turchia (Türkiye), 34093
        • Reclutamento
        • Istanbul University Faculty of Medicine, Capa State Hospital
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

12 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

  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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Controllo
Droga: Heparin

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

for central venous catheter installation use

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

CorMedix Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 maggio 2025

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

15 gennaio 2025

Primo inviato che soddisfa i criteri di controllo qualità

6 febbraio 2025

Primo Inserito (Effettivo)

12 febbraio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NUTRI-GUARD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

Pending FDA Approval

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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