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Идёт набор NCT05453695

Intravenous DNase I for the Treatment of Sepsis (IDEALSepsisI)

Фаза I С лечением Sepsis Critical Illness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intravenous DNase I.
Кому может быть актуально
Состояния в реестре: Sepsis, Critical Illness. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Intravenous DNase I for the Treatment of Sepsis: A Phase I Safety and Feasibility Study in ICU Patients

Обзор

Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients.

Подробное описание

In sepsis, the release of 'neutrophil extracellular traps' (NETs) by activated neutrophils may contribute to organ damage by acting as scaffolds that trap blood cells and fibrin clots. Excessive NET formation can occlude the vasculature, promoting thrombosis and tissue hypoperfusion. This is a trial on a novel IV therapy for septic patients that shows promise in multiple animal models of sepsis. The therapy, DNase I, is an enzyme that helps to dismantle NETs by digesting cell-free DNA (cfDNA), the major structural component of NETs. The objective of this study is to conduct a Phase I dose-escalation safety and feasibility of IV DNase I in ICU septic patients. The results of this study may justify a future Phase II trial of the efficacy and safety of DNase I for critically ill patients with sepsis.

This trial proposes

1. \- To determine the safety, feasibility and maximum tolerated dose (MTD) of using DNase I in septic patients 2. \- To evaluate clinical endpoints common in the critically ill such as organ dysfunction severity and trajectory, ICU length of stay, and mortality. 3. \- To describe the effects of DNase I on blood coagulation and NETs release 4. \- To collect samples for future studies on coagulation and immune function in sepsis.

Вмешательства

  • Препарат Intravenous DNase I
    Dose-escalating intravenous infusion of DNase I

Первичные конечные точки

  • Number of patients recruited per month from the start of the study [Срок оценки: up to 24 months]
  • Number of patients who completed the protocol [Срок оценки: up to 7 days]
Вторичные конечные точки (7)
  • Sequential Organ Failure Assessment (SOFA) score [Срок оценки: Baseline to Day 10]
  • Organ support free days [Срок оценки: at Day 28]
  • Duration of ICU admission [Срок оценки: up to 9 months]
  • Time to Hospital discharge [Срок оценки: up to 90 days]
  • Mortality at Day 90 [Срок оценки: up to day 90]
  • European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score [Срок оценки: At day 90]
  • Collection of Research Biomarkers related to inflammation and coagulation [Срок оценки: up to day 14]

Критерии участия

Критерии включения

  • Age of ≥18 years
  • Admitted to the ICU in the last 48 hours
  • Suspected or proven infection as the admitting diagnosis
  • A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline
  • Expected to remain in the ICU for ≥ 72 hours

Критерии исключения

  • No consent/inability to obtain consent from a substitute decision-maker
  • Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock
  • Have a significant risk of bleeding as evidenced by one of the following:
  • Surgery requiring general or spinal anesthesia within 24 hours before enrolment
  • The potential need for surgery in the next 24 hours
  • Evidence of active bleeding
  • A history of severe head trauma requiring hospitalization
  • Intracranial surgery, or stroke within three months before the study
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system
  • A history of congenital bleeding diatheses
  • Gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed
  • Trauma is considered to increase the risk of bleeding
  • Presence of an epidural catheter
  • Need for therapeutic anticoagulation
  • Receiving DNase I by inhalation
  • Terminal illness with a life expectancy of fewer than three months
  • Pregnant and/or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Hamilton Health Sciences — Hamilton

Публикации

  • Sharma N, Dwivedi DJ, Fux L, Hayon Y, Ruderfer I, Nataf Y, Cani E, Liaw PC. Intravenous Delivery of Long-Acting Dnase I (PRX-119) In a Murine Model of Polymicrobial Abdominal Sepsis. Shock. 2026 Jan 1;65(1):76-84. doi: 10.1097/SHK.0000000000002666. Epub 2025 Jul 8. PMID 40705350

Идентификаторы

NCT: NCT05453695 · IDEALSepsisI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗