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Идёт набор NCT06701890

Observational Study of Travellers Pathologies

Без фазы С лечением Travel-Related 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: Blood sample collection, Fecal sample collection.
Кому может быть актуально
Состояния в реестре: Travel-Related Illness. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.These conditions are associated with behavioral, geographical, or environmental risk factors. A better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues. The main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory.

Подробное описание

Traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.These conditions are associated with behavioral, geographical, or environmental risk factors. A better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues.

The main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory.

Furthermore, two key aspects from a Public Health perspective are associated with travel and the globalization of exchanges: the acquisition of emerging pathogens or pathogens with antimicrobial resistance of concern.

To study these two aspects, the EOP study includes two sub-studies called EOP-Arbo and EOP-AMR.

* EOP-Arbo : The objective of this sub-study is to determine the risk of contracting an arboviral disease during travel, as well as the factors that may favor infection. For this, blood samples will be collected. * EOP-AMR : The objective of this sub-study is to determine the risk of contracting an antibiotic-resistant bacteria during the trip. For this, faecal samples will be collected.

Вмешательства

  • Другое Blood sample collection
    16 mL at inclusion 16 mL at 1 month after return from travel
  • Другое Fecal sample collection
    1 sample at inclusion 1 sample at day 1, day 7, day 14, day 21, 1 month and 2 month after return from travel

Первичные конечные точки

  • Determine the incidence of pathologies occurring during a travel outside the metropolitan territory. [Срок оценки: 10 years]
Вторичные конечные точки (2)
  • For EOP-Arbo sub-study : Determine the prevalence for the occurrence of an arboviral disease (dengue, chikungunya, Zika) during the travel. [Срок оценки: 10 years]
  • For EOP-AMR sub-study : Determine the prevalence for the acquisition of multi-resistant bacteria (MRB) during the travel. [Срок оценки: 10 years]

Критерии участия

  • Inclusion Criteria :
  • For all participants in the EOP study :
  • Major subject (age ≥ 18)
  • Owns a smartphone compatible with electronic data collection
  • Preparing to travel outside mainland France
  • Affiliated with or covered by Social Security or private insurance
  • Willing to participate in the EOP study
  • For the EOP-Arbo Sub-study :

\- Subject who has consented to participate in the EOP\_Arbo study.

  • For the EOP-AMR Sub-study :
  • Subject who has consented to participate in the EOP\_AMR study.
  • Exclusion Criteria:
  • For all participants in the EOP study :
  • Travel duration ≤ 3 days
  • Travel duration > 12 months
  • Person traveling as part of an expatriation without planned movement outside the settlement in the destination country
  • Person under legal protection or unable to express consent for participation
  • For the EOP-Arbo Sub-study :

\- Individuals deemed clinically and/or biologically unfit by the investigator to undergo the blood samples required for the study.

  • For the EOP-AMR Sub-study :
  • No specific exclusion criteria.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • Medical Center of Institut Pasteur — Paris

Идентификаторы

NCT: NCT06701890 · 2022-069 · 2023-A02574-41

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗