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Recruiting NCT06701890

Observational Study of Travellers Pathologies

No phase Interventional Travel-Related Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample collection, Fecal sample collection.
Who it may be relevant to
Registry conditions: Travel-Related Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

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

Eligibility criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Medical Center of Institut Pasteur — Paris

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗