Observational Study of Travellers Pathologies

NCT ID: NCT06701890

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

11000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2036-12-31

Brief Summary

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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

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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.

Conditions

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Travel-Related Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adults planning to travel outside metropolitan France.

Human biological samples :

* Blood sample
* fecal sample

Group Type EXPERIMENTAL

Blood sample collection

Intervention Type OTHER

16 mL at inclusion 16 mL at 1 month after return from travel

Fecal sample collection

Intervention Type OTHER

1 sample at inclusion

1 sample at day 1, day 7, day 14, day 21, 1 month and 2 month after return from travel

Interventions

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Blood sample collection

16 mL at inclusion 16 mL at 1 month after return from travel

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.

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 :
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabien TAIEB, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center of Institut Pasteur

Locations

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Medical Center of Institut Pasteur

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fabien TAIEB, MD

Role: CONTACT

0140613456 ext. +33

Julia ABAD

Role: CONTACT

Facility Contacts

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Fabien TAIEB, MD

Role: primary

Other Identifiers

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2023-A02574-41

Identifier Type: OTHER

Identifier Source: secondary_id

2022-069

Identifier Type: -

Identifier Source: org_study_id

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