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Studio in aperto a due bracci per valutare la sicurezza e il tempo di insorgenza di CRBSI in soggetti dalla nascita a < 18 anni di età

22 settembre 2026 aggiornato da: CorMedix Therapeutics

Uno studio in aperto, a due bracci (DefenCath® vs. standard di cura istituzionale) per valutare la sicurezza e il tempo di insorgenza di infezioni del flusso sanguigno correlate al catetere (CRBSI) in soggetti dalla nascita a meno di 18 anni di età con insufficienza renale sottoposti a emodialisi tramite un catetere venoso centrale

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

36

Fase

  • Fase 4

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

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Reclutamento
        • Children's of Alabama/University of Alabama
        • Contatto:
        • Contatto:
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85016
    • California
      • Palo Alto, California, Stati Uniti, 94304
    • Delaware
      • Wilmington, Delaware, Stati Uniti, 19803
    • New Jersey
      • Hackensack, New Jersey, Stati Uniti, 07601
        • Reclutamento
        • Hackensack University Medical Center
        • Contatto:
        • Contatto:
    • Texas

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

Non più vecchio di 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • All participants must be < 18 years of age and must meet the following inclusion criteria:
  • 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.
  • 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.
  • The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.
  • The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.
  • 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.
  • The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.
  • The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.
  • The participant is not expected to expire within 180 days, based on clinical assessment.
  • Female participants of childbearing potential:
  • 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.
  • 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:
  • 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).

Combined (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.

  • Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
  • Bilateral tubal occlusion/ligation.
  • Intrauterine device.
  • Intrauterine hormone releasing system.
  • Vasectomized partner.
  • 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.
  • 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.

Exclusion Criteria:

  • Any participant who is currently receiving systemic antibiotics. Topical antibiotic use is permitted.
  • Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.
  • 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.
  • The fill volume of catheter lumen(s) is unknown or cannot be determined.
  • The participant uses any type of antimicrobial-coated or heparin-coated catheter.
  • Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.
  • Documented history of an atrial thrombus or known hypercoagulable state.
  • The participant has open, non-healing skin ulcers.
  • Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
  • The participant has current requirement for systemic chemotherapy and/or immunosuppression and absolute neutrophil count <500 cells/µL that occurred in the past 4 weeks.
  • 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/or immunosuppression.
  • Known allergy or absolute contraindication to taurolidine, citrate, or heparin, or a history of heparin induced thrombocytopenia (HIT).
  • Unstable malignancy.
  • Cirrhosis with encephalopathy.
  • The participant is currently taking another medication with known systemic drug interaction with taurolidine, citrate, or heparin.
  • 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).
  • The participant has a clinically significant cardiac rhythm or functional disorder.
  • The participant has severe hypoxemia, respiratory acidosis, asphyxia, or hypotension prior to randomization based on assessment of the investigator.
  • 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.

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Controllo
Droga: Standard of Care

Site specific standard of care
Sperimentale: DefenCath®
Droga: (taurolidine and heparin) catheter lock solution

for central venous catheter instillation use

Altri nomi:
  • DefenCath®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI)
Lasso di tempo: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To demonstrate the effectiveness of DefenCath as a catheter lock solution (CLS) for prevention of CRBSI in pediatric participants receiving chronic hemodialysis (HD) through a central venous catheter (CVC) for the treatment of kidney failure.
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)
Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs
Lasso di tempo: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To demonstrate safety of DefenCath as a CLS in pediatric participants receiving chronic HD through a CVC for the treatment of kidney failure
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to catheter removal due to CRBSI
Lasso di tempo: Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

To evaluate the catheter removal due to CRBSI in pediatric participants who are receiving chronic HD through a CVC for kidney failure.
Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 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)

8 luglio 2025

Completamento primario (Stimato)

1 luglio 2028

Completamento dello studio (Stimato)

1 aprile 2029

Date di iscrizione allo studio

Primo inviato

2 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

2 dicembre 2024

Primo Inserito (Effettivo)

4 dicembre 2024

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

  • PEDI-LOCK

Piano per i dati dei singoli partecipanti (IPD)

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

INDECISO

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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