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Идёт набор NCT04629053

Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia

Наблюдательное Acute Febrile 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Febrile Illness. Базовые параметры: от 29 Days · 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
Bangladesh, Laos, Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Determining the Causes and Outcomes of Febrile Illness in Health Care Facilities in Rural South and Southeast Asia, as Part of the South and Southeast Asian Community-based Trials Network (SEACTN). Work Package B (WP-B).

Обзор

This prospective multi-site observational study aims to describe causes and clinical outcomes of acute febrile illness as well as host biomarkers in patients aged \>28 days residing in rural areas in Laos, Myanmar, Thailand, the Thai-Myanmar border region, and Bangladesh and presenting with acute febrile illnesses (≤ 14 days duration) to participating health facilities. This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z

Подробное описание

The majority of people in low- and middle-income countries (LMICs) in South and Southeast Asia live in rural areas. These people are some of the poorest in the region and the exact health issues which concern them have not been well defined, in that they have not been fully studied. Despite this lack of data, there are indications that disease of an infectious aetiology, 'febrile illness,' in particular in the tropics, still accounts for significant morbidity and mortality. This is in contrast to higher-income countries.

The South and Southeast Asian Community-based Trials Network in Rural Febrile Illness project (SEACTN RFI) aims to better understand and quantify the burden of febrile illness, the aetiological causes and the manner in which it affects the people of the area, all on a scale which has not been attempted before. It will collect information to help better understand and predict these outcomes based on a multitude of factors, which will form the basis for interventions within the network in the future. The initial study will be observational, as the current understanding of the local health issues and the health systems in these areas is insufficient to know how best to intervene.

In a separate work package, Work Package A (WP-A), the investigators will be collecting data from within the participating SEACTN communities through village health workers (VHWs) and local health facilities on the incidence, causes and outcomes of febrile illness in these areas.

In Work Package B (WP-B) will recruit patients seeking care at higher level facilities than the WP-A VHWs and health centres. These patients are likely to be more severely ill, in order to obtain a more thorough understanding of the causes and burden of febrile illness in these areas. A broader range of specimens, including venous blood samples and respiratory specimens will be collected. In-depth diagnostic testing including blood cultures, serological assays, pathogen molecular diagnostics, host biomarker assays, and validation of pathogen-blind next generation sequencing approaches will be conducted. The data from WP-A gathered in the community complemented by the WP-B data from higher level health facilities in the same regions will provide a rich understanding of the causes, incidence and outcomes of febrile illness in these areas. These data will be analysed using advanced statistical methodology to create electronic decision-support tools (eDSTs) to aid VHWs in their assessment, triage and treatment of patients. These and other relevant interventions will later be trialled across the SEACTN villages.

Первичные конечные точки

  • Prevalence of pathogens [Срок оценки: Samples collected over approximately 1 month]
Вторичные конечные точки (2)
  • Recovery status [Срок оценки: Approximately 1 month]
  • The association between host biomarkers and other predictors with aetiological diagnoses and clinical outcomes [Срок оценки: Samples collected over approximately 1 month]

Критерии участия

Критерии включения

  • The patient and/or where relevant their parent/guardian/caretaker is willing and able to give informed consent /assent for participation in the study;
  • Aged > 28 days (day of birth = Day 1);
  • Axillary temperature at presentation (≥ 37.5°C (99.5°F) OR < 35.5°C (95.9°F)) and no more likely cause than sepsis for hypothermia OR History of fever in the 24 hours prior to presentation;
  • Onset of illness ≤ 14 days

Критерии исключения

  • Accident or trauma is the cause for the patient's presentation;
  • Presentation ≤ 3 days after routine immunisations
  • Is currently under follow-up or has been afebrile for less than 72 hours after completion of a follow-up period.
  • The treating healthcare worker's decision is to send the patient home following initial assessment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Таиланд · 2 центра
  • Shoklo Malaria Research Unit — Mae Sot
  • Chiangrai Clinical Research Unit (CCRU) — Chiang Rai
Bangladesh · 1 центр
  • Building Resources Across Communities (BRAC) — Dhaka
Laos · 1 центр
  • Laos-Oxford-Mahosot Wellcome Trust Research Unit — Vientiane

Идентификаторы

NCT: NCT04629053 · BAC20003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗