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Étude ouverte à deux bras pour évaluer la sécurité et le délai d'administration du CRBSI chez des sujets de la naissance à < 18 ans

22 septembre 2026 mis à jour par: CorMedix Therapeutics

Une étude ouverte à deux bras (DefenCath® par rapport à la norme de soins institutionnelle) pour évaluer la sécurité et le délai d'apparition des infections sanguines liées au cathéter (CRBSI) chez des sujets de la naissance à moins de 18 ans atteints d'insuffisance rénale recevant une hémodialyse via un cathéter veineux central

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

36

Phase

  • Phase 4

Accès étendu

Plus disponible en dehors de l'essai clinique. Voir enregistrement d'accès étendu.

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Recrutement
        • Children's of Alabama/University of Alabama
        • Contact:
          • Sahar Fathallah-Shaykh, MD
          • Numéro de téléphone: 205-638-9781
          • E-mail: sfshaykh@uabmc.edu
        • Contact:
    • Arizona
      • Phoenix, Arizona, États-Unis, 85016
    • California
      • Palo Alto, California, États-Unis, 94304
    • Delaware
      • Wilmington, Delaware, États-Unis, 19803
    • New Jersey
      • Hackensack, New Jersey, États-Unis, 07601
        • Recrutement
        • Hackensack University Medical Center
        • Contact:
        • Contact:
    • Texas

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Contrôler
Médicament: Standard of Care

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

for central venous catheter instillation use

Autres noms:
  • DefenCath®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI)
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to catheter removal due to CRBSI
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

CorMedix Therapeutics

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 juillet 2025

Achèvement primaire (Estimé)

1 juillet 2028

Achèvement de l'étude (Estimé)

1 avril 2029

Dates d'inscription aux études

Première soumission

2 décembre 2024

Première soumission répondant aux critères de contrôle qualité

2 décembre 2024

Première publication (Réel)

4 décembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PEDI-LOCK

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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