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Набор скоро начнётся NCT07075029

RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China

— Наблюдательное Acute Respiratory Infections (ARIs)

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: NP swabs.
Кому может быть актуально
Состояния в реестре: Acute Respiratory Infections (ARIs). Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China: A Prospective, Observational, Community-Based Study

Обзор

This is a multicenter, prospective, observational, community-based study designed to evaluate the incidence of respiratory syncytial virus (RSV) infection among community-dwelling elderly individuals in China, as well as their cohabiting older adults and children, over a 24-month period. During the study, home visits will be conducted to collect nasopharyngeal (NP) swabs from all community residents aged ≥50 years who report symptoms of acute respiratory infection (ARI). Pathogen detection will be performed using both point-of-care testing (POCT) and centralized laboratory analysis.

Подробное описание

The study will cover about 10 communities representing diverse geographical locations, economic conditions, and population densities.

Вмешательства

  • Диагностический тест NP swabs
    Nasopharyngeal (NP) swabs will be collected from all participants for respiratory pathogen detection using point-of-care testing (POCT) and/or centralized laboratory analysis.

Первичные конечные точки

  • Incidence rate of RSV [Срок оценки: From September 2025 to September 2027]
Вторичные конечные точки (3)
  • Positive rate of RSV [Срок оценки: From September 2025 to September 2027.]
  • Prevalence [Срок оценки: From September 2025 to September 2027.]
  • Association between symptoms and pathogens [Срок оценки: From enrollment to the final sample collection on Day 7.]

Критерии участия

Критерии включения

  • CRE-ARI group:
  • Male or female adults aged ≥50 years (calculated based on date of birth and date of visit).
  • Presence one of the following conditions of ARI case definition :
  • At least two respiratory symptoms/signs within 48 hours prior to self-reporting OR
  • At least one respiratory symptom/sign + one systemic symptom/sign within 48 hours prior to self-reporting
  • Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.
  • CAI group:
  • In the household, include at least one patient meeting the inclusion criteria (index case\[s\]) of CRE-ARI group.
  • Male or female adults aged ≥50 years or children aged<5 years (calculated based on date of birth and date of visit).
  • In the household, apart from the index case(s), there are two or more members who meet the criteria (2) AND are willing to participate, regardless of whether these household members exhibit ARI symptoms.
  • Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.

Критерии исключения

  • Enrollment in the CRE-ARI group within the preceding 14 days.
  • Enrollment in the CRE-ARI group has been more than 4 times during the previous 12 months (applicable only to the CRE-ARI group enrollment).
  • For CAI group, if a household has been enrolled into CAI group within the previous 12 months.
  • Residence outside the designated study catchment area.
  • Unwilling to provide consent/assent (if applicable) to participate.
  • Unwilling to provide biological samples.
  • Any other situation deemed inappropriate for participation by the investigator, including potential risks to the subject upon enrollment or factors that may affect the interpretation of study results, such as clinical judgment, safety concerns, or the integrity of the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 13 центров
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
  • Affiliated Hospital of Zunyi Medical University — Zunyi
  • The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
  • The Third People's Hospital of Yichang — Yichang
  • Nanjing Municipal Hospital of Traditional Chinese Medicine — Нанкин
  • First People's Hospital of Jiujiang — Jiujiang
  • The Sixth People's Hospital of Shenyang — Шэньян
  • … и ещё 5 центров

Идентификаторы

NCT: NCT07075029 · RAISE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗