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Набор скоро начнётся NCT07328984

How Long Should we Give Steroids for Patients With Severe PCP

Фаза IV С лечением Pneumocystis Pneumonia Pneumocystis Pneumocystis Jirovecii Infection Pneumocystis Jiroveci Pneumonia

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: Systemic corticosteroids.
Кому может быть актуально
Состояния в реестре: Pneumocystis Pneumonia, Pneumocystis, Pneumocystis Jirovecii Infection, Pneumocystis Jiroveci Pneumonia. Базовые параметры: от 18 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

How Long Should we Give Steroids for Patients With Severe PCP (HOW LONG)

Обзор

The HOW LONG trial is an international, multicenter, Phase IV randomized clinical trial evaluating the optimal duration of adjunctive systemic corticosteroids in immunocompromised adults with severe Pneumocystis jirovecii pneumonia (PCP) who demonstrate early clinical recovery. Participants who no longer require supplemental oxygen by day 10 of corticosteroid therapy are randomized to discontinue corticosteroids at day 10 (or hospital discharge, if earlier) versus continue corticosteroids for a total of 21 days. The trial assesses whether earlier discontinuation reduces steroid-related complications while maintaining clinical outcomes.

Подробное описание

Adjunctive systemic corticosteroids are routinely used in severe PCP to reduce pulmonary inflammation and improve survival, but the recommended 21-day duration is based on limited historical evidence. Prolonged corticosteroid exposure may increase risks including secondary infections, hyperglycemia, gastrointestinal bleeding, and other adverse effects. The HOW LONG trial tests whether stopping corticosteroids earlier, after clinical recovery, improves net clinical outcomes.

Eligible adults with proven or probable severe PCP who have recovered to room air (no need for supplemental oxygen) for at least 6 hours by day 10 of corticosteroid therapy are enrolled and randomized centrally 1:1 in the MUHC Research Electronic Data Capture (REDCap) system to (1) discontinuation of corticosteroids at day 10 or hospital discharge or (2) continuation of corticosteroids to a total of 21 days. All participants receive standard antimicrobial therapy for PCP per treating clinicians. Follow-up occurs to day 180.

The primary endpoint is a hierarchical composite outcome assessed at day 60, incorporating mortality, relapse of PCP-related hypoxemia, secondary infections, severe metabolic or gastrointestinal complications, and length of hospital stay. Secondary endpoints include individual components of the composite outcome, and tertiary endpoints include quality of life and longer-term outcomes through day 180.

Вмешательства

  • Препарат Systemic corticosteroids
    Adjunctive systemiccorticosteroid therapy administered as part of standard treatment for pneumocystis Pneumonia, with duration varying by study arm.

Первичные конечные точки

  • Hierarchical composite clinical outcome [Срок оценки: Day 60]
Вторичные конечные точки (6)
  • Death [Срок оценки: Day 60]
  • relapse of PCP-related hypoxemia [Срок оценки: Day 60]
  • Secondary infections requiring systemic antibiotic therapy [Срок оценки: Day 60]
  • The development of severe diabetic complications [Срок оценки: Day 60]
  • The development of severe GI bleeding ( [Срок оценки: Day 60]
  • inpatient length of stay (censored at day 60; deaths assigned 60 days). [Срок оценки: Day 60]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Proven or probable Pneumocystis jirovecii pneumonia
  • Severe PCP requiring supplemental oxygen (e.g., ≥4 L/min or ≥35% FiO₂ to maintain SpO₂ ≥94%)
  • Planned or receiving adjunctive systemic corticosteroid therapy for severe PCP
  • Clinical recovery by day 10 of steroid therapy: breathing room air for ≥6 hours
  • Able to provide informed consent (or per local requirements)

Критерии исключения

  • Persistent hypoxemia or ongoing oxygen requirement at day 10
  • Clinical deterioration prior to randomization
  • Treating clinician determines steroids must be continued or stopped immediately for medical reasons
  • Anticipated death within 48 hours
  • Inability or unwillingness to complete follow-up through day 180

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital — Montreal

Публикации

  • Senecal J, Smyth E, Del Corpo O, Hsu JM, Amar-Zifkin A, Bergeron A, Cheng MP, Butler-Laporte G, McDonald EG, Lee TC. Non-invasive diagnosis of Pneumocystis jirovecii pneumonia: a systematic review and meta-analysis. Clin Microbiol Infect. 2022 Jan;28(1):23-30. doi: 10.1016/j.cmi.2021.08.017. Epub 2021 Aug 28. PMID 34464734
  • McDonald EG, Butler-Laporte G, Del Corpo O, Hsu JM, Lawandi A, Senecal J, Sohani ZN, Cheng MP, Lee TC. On the Treatment of Pneumocystis jirovecii Pneumonia: Current Practice Based on Outdated Evidence. Open Forum Infect Dis. 2021 Oct 29;8(12):ofab545. doi: 10.1093/ofid/ofab545. eCollection 2021 Dec. PMID 34988242

Идентификаторы

NCT: NCT07328984 · 2026-12265 · 527077

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗