Observational Study of Travellers Pathologies (EOP)

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.

Study Overview

• Status: Recruiting
• Conditions: Travel-Related Illness
• Intervention / Treatment: Other: Blood sample collection; Other: Fecal sample collection

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.

• Study Type: Interventional
• Enrollment (Estimated): 11000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia ABAD; Email: julia.abad@pasteur.fr
• Study Contact Backup: Name: Fabien TAIEB, MD; Phone Number: +33 0140613456; Email: fabien.taieb@pasteur.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Medical Center of Institut Pasteur
    • Contact: Fabien TAIEB, MD; Email: fabien.taieb@pasteur.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults planning to travel outside metropolitan France.; Human biological samples : Blood sample; fecal sample	Other: Blood sample collection; 16 mL at inclusion 16 mL at 1 month after return from travel; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the incidence of pathologies occurring during a travel outside the metropolitan territory.	Number of subjects who developed a pathology during the travel among participants	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For EOP-Arbo sub-study : Determine the prevalence for the occurrence of an arboviral disease (dengue, chikungunya, Zika) during the travel.	Number of arboviral diseases (dengue, chikungunya, Zika) during the travel among participants	10 years
For EOP-AMR sub-study : Determine the prevalence for the acquisition of multi-resistant bacteria (MRB) during the travel.	Proportion of subjects with multi-resistant bacteria acquired during the travel	10 years

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Investigators: Principal Investigator: Fabien TAIEB, MD, Medical Center of Institut Pasteur

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Risk Factors; Travel; Pathology; Arbovirose
• Additional Relevant MeSH Terms: Travel-Related Illness
• Other Study ID Numbers: 2022-069; 2023-A02574-41 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No