Effect of tNGS on CAP Patients With Initial Treatment Failure

Официальное название

Impact of Targeted Next-generation Sequencing on Hospitalized Patients With Community-acquired Pneumonia and Initial Treatment Failure

Обзор

This is a multicenter, randomized controlled trial designed to evaluate the impact of tNGS in patients with community-acquired pneumonia who experience initial treatment failure.

Подробное описание

Community-acquired pneumonia (CAP) is a common respiratory disease and poses a major threat to global health. CAP can be caused by a wide range of respiratory pathogens, including viruses, bacteria, and fungi. However, conventional microbiological tests often fail to identify the causative pathogens, making etiological diagnosis challenging and limiting the implementation of individualized treatment strategies, which may affect patient prognosis.

Targeted next-generation sequencing (tNGS) enables the simultaneous detection of hundreds of common respiratory pathogens at a relatively low cost and has significantly improved pathogen detection rates. To further evaluate the impact of tNGS on clinical decision-making and patient outcomes in real-world practice, a multicenter randomized controlled trial is proposed by the investigators, enrolling patients with community-acquired pneumonia who experience initial treatment failure. Participants will be randomly assigned in a 1:1 ratio to either the tNGS group or the conventional testing group. Patients in the tNGS group will undergo tNGS in addition to conventional microbiological testing, whereas those in the conventional testing group will receive conventional microbiological testing alone. Length of hospital stay and other clinical effectiveness endpoints will be compared between the two groups.

Вмешательства

• Диагностический тест Targeted next-generation sequencing
  Bronchoalveolar lavage fluid (BALF) or sputum samples will be collected within 72 hours after randomization and sent for targeted next-generation sequencing (tNGS). The test results will be reported to the attending physician within 1-2 days.
• Диагностический тест Conventional microbiological testing
  Bronchoalveolar lavage fluid (BALF) or sputum samples will be collected within 72 hours after randomization and sent for conventional microbiological testing. The type of conventional microbiological testing will be determined by the attending physician, and test results will be reported in approximately one week
• Другое Follow-up at Day 30
  A telephone visit will be conducted on or around Day 30 for study participants who are discharged or transferred to another hospital due to disease exacerbation, to collect information on survival, ICU admissions, mechanical ventilation, and medical costs.

Первичные конечные точки

• Length of hospital stay [Срок оценки: 30 days]

Вторичные конечные точки (10)

• 30-day mortality [Срок оценки: 30 days]
• ICU admission rate [Срок оценки: 30 days]
• Length of stay in ICU [Срок оценки: 30 days]
• Incidence of mechanical ventilation [Срок оценки: 30 days]
• Duration of mechanical ventilation [Срок оценки: 30 days]
• 5-Day Antibiotic Modification Rate [Срок оценки: 5 days]
• 3-Day Antibiotic Modification Rate [Срок оценки: 3 days]
• 5-Day Other Antimicrobial Agents Modification Rate [Срок оценки: 5 days]
• 3-Day Other Antimicrobial Agents Modification Rate [Срок оценки: 3 days]
• Cost of hospitalization [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Adults (age ≥ 18 years)
• Diagnosed of community-acquired pneumonia
• Initial treatment failure

Критерии исключения

• tNGS or mNGS already performed on respiratory samples during the current illness
• Suspected lung abscess or empyema
• Cerebral infarction within the past three months
• Dysphagia
• Nasopharyngeal carcinoma currently receiving radiotherapy
• Tracheostomy
• Long-term bedridden patients (ADL score ≤ 60)
• Pathogens identified within the past 7 days that adequately explain the current clinical presentation
• Bronchiectasis with large amounts of sputum and documented bacterial detection within the past six months
• Inability to obtain eligible respiratory samples
• CURB-65 score ≤ 1
• Expected discharge or death within 48 hours

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship hospital — Пекин

Идентификаторы

NCT: NCT07472114 · 2024-1-4063

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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