NCT04672577

Brief Summary

The investigators hypothesize that sex, age, area of exposure and purpose of travel are associated with different travel-related infections. The investigators also hypothesize that certain infections will have long-term sequelae. Health-data will be collected from travellers from Switzerland and Europe. The project starts with a pilot study for 50 travellers, followed by the recruiting of 10,000 travellers. The data collection will be via a mobile App (ITIT). The ITIT App will collect active data from travellers. The participants will download the App after signing an electronic consent form and completing a baseline questionnaire. Then the travellers will answer a short daily questionnaire about illness symptoms during travel. The ITIT App will also collect passive data (GPS localisation, environmental and weather data). The project will provide real-time data on travel-related infections and profile travel illness by age, sex and purpose of travel and also identify outbreaks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

3.9 years

First QC Date

December 8, 2020

Last Update Submit

December 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of travel-related infectious diseases

    The Likert scale, self-rating of severity is the unit used to evaluate infectious disease symptoms based on 4 health domains (gastrointestinal symptoms, respiratory symptoms, skin infections and rashes, fever, pain and myalgia) combined with the number of travellers reporting symptoms to get the incidence (travelers with illnesses per 100 travellers).

    8 weeks

Secondary Outcomes (2)

  • long-term sequelae of arboviral infections and malaria

    1 year

  • change in epidemiology of travel-related infectious diseases

    1 year

Study Arms (1)

Arboviral infection or malaria positive cohort

Other: Observational study

Interventions

No intervention is planned

Arboviral infection or malaria positive cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

International travellers who cross international borders and are traveling for varying purposes such as business/corporate travellers, those visiting friends and relatives (VFR), leisure/tourist travellers and mass gathering events (Hajj, Olympics, World Cup) attendees.

You may qualify if:

  • travellers who cross international borders
  • adults (over 18 years old)
  • those traveling for more than 2 days and less than 8 weeks

You may not qualify if:

  • Non travellers (not crossing international borders)
  • Minors (under 18 years old)
  • those traveling for less than 2 days and longer than 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epidemiology, Biostatistics and Prevention Institute at the University of Zurich

Zurich, 8001, Switzerland

Location

Related Publications (9)

  • Farnham A, Blanke U, Stone E, Puhan MA, Hatz C. Travel medicine and mHealth technology: a study using smartphones to collect health data during travel. J Travel Med. 2016 Sep 4;23(6):taw056. doi: 10.1093/jtm/taw056. Print 2016 Jun.

    PMID: 27592821BACKGROUND
  • Findlater A, Moineddin R, Kain D, Yang J, Wang X, Lai S, Khan K, Bogoch II. The use of air travel data for predicting dengue importation to China: A modelling study. Travel Med Infect Dis. 2019 Sep-Oct;31:101446. doi: 10.1016/j.tmaid.2019.07.002. Epub 2019 Jul 5.

    PMID: 31284067BACKGROUND
  • Leta S, Beyene TJ, De Clercq EM, Amenu K, Kraemer MUG, Revie CW. Global risk mapping for major diseases transmitted by Aedes aegypti and Aedes albopictus. Int J Infect Dis. 2018 Feb;67:25-35. doi: 10.1016/j.ijid.2017.11.026. Epub 2017 Nov 28.

    PMID: 29196275BACKGROUND
  • Ponce C, Dolea C. The World Health Organisation (WHO) and International Travel and Health: New collaborative, evidence-based and digital directions. Travel Med Infect Dis. 2019 Jan-Feb;27:1. doi: 10.1016/j.tmaid.2019.01.012. Epub 2019 Jan 17. No abstract available.

    PMID: 30660556BACKGROUND
  • Schlagenhauf P, Chen LH, Wilson ME, Freedman DO, Tcheng D, Schwartz E, Pandey P, Weber R, Nadal D, Berger C, von Sonnenburg F, Keystone J, Leder K; GeoSentinel Surveillance Network. Sex and gender differences in travel-associated disease. Clin Infect Dis. 2010 Mar 15;50(6):826-32. doi: 10.1086/650575.

    PMID: 20156059BACKGROUND
  • Schlagenhauf P, Tschopp A, Johnson R, Nothdurft HD, Beck B, Schwartz E, Herold M, Krebs B, Veit O, Allwinn R, Steffen R. Tolerability of malaria chemoprophylaxis in non-immune travellers to sub-Saharan Africa: multicentre, randomised, double blind, four arm study. BMJ. 2003 Nov 8;327(7423):1078. doi: 10.1136/bmj.327.7423.1078.

    PMID: 14604928BACKGROUND
  • Tomasello D, Schlagenhauf P. Chikungunya and dengue autochthonous cases in Europe, 2007-2012. Travel Med Infect Dis. 2013 Sep-Oct;11(5):274-84. doi: 10.1016/j.tmaid.2013.07.006. Epub 2013 Aug 17.

    PMID: 23962447BACKGROUND
  • Hedrich N, Lovey T, Bernhard J, Grobusch MP, Gautret P, Schlagenhauf P; ITIT Global Network. Real-time illness monitoring in travellers: an international, prospective, digital surveillance study. Travel Med Infect Dis. 2025 Nov-Dec;68:102943. doi: 10.1016/j.tmaid.2025.102943. Epub 2025 Nov 17.

  • Lovey T, Hedrich N, Grobusch MP, Bernhard J, Schlagenhauf P; ITIT Global Network. Surveillance of global, travel-related illness using a novel app: a multivariable, cross-sectional study. BMJ Open. 2024 Jul 27;14(7):e083065. doi: 10.1136/bmjopen-2023-083065.

MeSH Terms

Conditions

Travel-Related IllnessMalariaDengueChikungunya FeverZika Virus InfectionSevere Acute Respiratory SyndromeInfluenza, HumanDiarrhea

Interventions

Observation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae InfectionsRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRespiratory Tract DiseasesOrthomyxoviridae InfectionsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 17, 2020

Study Start

January 30, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations