Clinical trial NCT06701890: Observational Study of Travellers Pathologies
Official title: Observational Study of Travellers Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Travel-Related Illness
Keywords: Travel
Risk Factors
Pathology
Arbovirose
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 11000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 1. Inclusion Criteria :

   1. 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
   2. For the EOP-Arbo Sub-study :

      - Subject who has consented to participate in the EOP_Arbo study.
   3. For the EOP-AMR Sub-study :

      * Subject who has consented to participate in the EOP_AMR study.
2. Exclusion Criteria:

   1. 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
   2. 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.
   3. For the EOP-AMR Sub-study :

      * No specific exclusion criteria.

Primary outcomes:
measure: Determine the incidence of pathologies occurring during a travel outside the metropolitan territory.
timeFrame: 10 years
Secondary outcomes:
measure: For EOP-Arbo sub-study : Determine the prevalence for the occurrence of an arboviral disease (dengue, chikungunya, Zika) during the travel.
timeFrame: 10 years
measure: For EOP-AMR sub-study : Determine the prevalence for the acquisition of multi-resistant bacteria (MRB) during the travel.
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Medical Center of Institut Pasteur
Study officials:
affiliation: Medical Center of Institut Pasteur
name: Fabien TAIEB, MD
role: PRINCIPAL_INVESTIGATOR
References: