Travel-Related IllnessITITNCT04672577
Infection Tracking in Travellers. The Project Aims to Identify Profiles of Travel-associated Illness and to Follow up on Long-term Sequelae of Arboviral Infections and Malaria
An observational study of Travel-Related Illness and Malaria, run by Patricia Schlagenhauf at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Travel-Related Illness, Malaria, Dengue
- What is being tested?
- Observational study
- How many people
- 10,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- travellers who cross international borders
- adults (over 18 years old)
- those traveling for more than 2 days and less than 8 weeks
Who cannot join
- Non travellers (not crossing international borders)
- Minors (under 18 years old)
- those traveling for less than 2 days and longer than 8 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Epidemiology, Biostatistics and Prevention Institute at the University of Zurich
Zurich, 8001
Thibault Lovey, thibault.lovey@uzh.ch
Patricia Schlagenhauf, Prof.
About this study
Official title: Infection Tracking in Travellers (ITIT)
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.
Read the detailed description
International travel is growing exponentially. Globally, there will be a projected 1.8 billion traveller arrivals in 2030. Current surveillance of travellers' health is top-down (i.e., clinicians/laboratories report illness) and only a small proportion of illness events are captured. More data are needed on the types of infections acquired by different groups who have varying purposes of travel such as business/corporate travellers, those visiting friends and relatives (VFR), leisure/tourist travellers and mass gathering event (Hajj, Olympics, World Cup) attendees. More data are needed to profile infections in travellers according to age and sex as men and women have different infection susceptibilities. Infectious diseases, in particular the spread of malaria and "arboviral infections",(i.e. viruses such as dengue) pose major threats with changing epidemiology influenced by climate, environmental factors and human mobility. The extent and impact of these infections on travellers' health and their long-term sequelae have scarcely been evaluated. The collected data will allow the profiling of infections in travellers according to purpose of travel and according to age and sex. Men and women have different infection susceptibilities but there is just one study on this theme in the context of travel medicine Infectious diseases, in particular the spread of malaria and "arboviral infections", i.e. viruses such as dengue, chikungunya and Zika pose major threats with changing areas of transmission influenced by climate and mobility. Although airline statistics are available on traveller numbers, the volume of ill, returning, possibly viremic travellers entering areas, where susceptible vectors exist has never been quantified. The situation of a twin presence of viremic travellers and competent Aedes vectors may lead to the onward transmission of arboviral infections. The ITIT project, evaluating in-travel and post-travel illness profiles, coupled with geo-location and meteorological data, will yield the granular data needed for personalized travel medicine. This is important given the heterogenicity and increasing volume of global travellers. The project has the support of the World Health Organization (WHO). Since the data will be collected anonymously via a questionnaire on the designed mobile App and the study is non-interventional, the risk category for this project is minimal (A).
- Conditions
- Travel-Related Illness, Malaria, Dengue, Chikungunya, Zika, SARS-CoV Infection
- Being tested
- Observational study
- Medical subject headings
- Travel-Related Illness, Malaria, Dengue, Chikungunya Fever, Zika Virus Infection, Severe Acute Respiratory Syndrome, Influenza, Human, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention is planned
| Study group | Role | What they receive |
|---|---|---|
| Arboviral infection or malaria positive cohort | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (2)
long-term sequelae of arboviral infections and malaria
The quality-of-life scores and health survey SF-12 version scores will be combined to determine the difference in quality of life due to the infections studied.
Measured: 1 year
change in epidemiology of travel-related infectious diseases
Change in incidence of travel related infectious diseases over time (incidence change/time)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start30 Jan 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Travel-Related IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricia Schlagenhauf
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, Swiss Tropical & Public Health Institute, University Hospital, Geneva, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Responsible party
- Sponsor-investigator, Patricia Schlagenhauf, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672577
- Sponsor's protocol ID
- ITIT
- Acronym
- ITIT
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27592821Findlater 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.
PubMed 31284067Leta 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.
PubMed 29196275Ponce 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.
PubMed 30660556Schlagenhauf 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.
PubMed 20156059Schlagenhauf 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.
PubMed 14604928Tomasello 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.
PubMed 23962447Hedrich 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.
PubMed 41260318Lovey 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.
PubMed 39067885
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Tracking in Travellers (ITIT)
- ClinicalTrials.gov ID
- NCT04672577
- Acronym / sponsor ID
- ITIT / ITIT
- Conditions
- Travel-Related Illness, Malaria, Dengue, Chikungunya, Zika, SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Patricia SchlagenhaufUniversity, hospital or other
- Collaborators
- ETH Zurich, Swiss Tropical & Public Health Institute, University Hospital, Geneva, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Study start
- 30 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
International travel is growing exponentially. Globally, there will be a projected 1.8 billion traveller arrivals in 2030. Current surveillance of travellers' health is top-down (i.e., clinicians/laboratories report illness) and only a small proportion of illness events are captured. More data are needed on the types of infections acquired by different groups who have varying purposes of travel such as business/corporate travellers, those visiting friends and relatives (VFR), leisure/tourist travellers and mass gathering event (Hajj, Olympics, World Cup) attendees. More data are needed to profile infections in travellers according to age and sex as men and women have different infection susceptibilities. Infectious diseases, in particular the spread of malaria and "arboviral infections",(i.e. viruses such as dengue) pose major threats with changing epidemiology influenced by climate, environmental factors and human mobility. The extent and impact of these infections on travellers' health and their long-term sequelae have scarcely been evaluated. The collected data will allow the profiling of infections in travellers according to purpose of travel and according to age and sex. Men and women have different infection susceptibilities but there is just one study on this theme in the context of travel medicine Infectious diseases, in particular the spread of malaria and "arboviral infections", i.e. viruses such as dengue, chikungunya and Zika pose major threats with changing areas of transmission influenced by climate and mobility. Although airline statistics are available on traveller numbers, the volume of ill, returning, possibly viremic travellers entering areas, where susceptible vectors exist has never been quantified. The situation of a twin presence of viremic travellers and competent Aedes vectors may lead to the onward transmission of arboviral infections. The ITIT project, evaluating in-travel and post-travel illness profiles, coupled with geo-location and meteorological data, will yield the granular data needed for personalized travel medicine. This is important given the heterogenicity and increasing volume of global travellers. The project has the support of the World Health Organization (WHO). Since the data will be collected anonymously via a questionnaire on the designed mobile App and the study is non-interventional, the risk category for this project is minimal (A).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arboviral infection or malaria positive cohort | – | Other: Observational study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- travellers who cross international borders
- adults (over 18 years old)
- those traveling for more than 2 days and less than 8 weeks
Key exclusion criteria (3 listed)
- Non travellers (not crossing international borders)
- Minors (under 18 years old)
- those traveling for less than 2 days and longer than 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNo intervention is planned | Other | Arboviral infection or malaria positive cohort |
Primary outcome
incidence of travel-related infectious diseases
Time frame: 8 weeks
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).
2 secondary outcomes
long-term sequelae of arboviral infections and malaria
Time frame: 1 year
change in epidemiology of travel-related infectious diseases
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 27592821Farnham 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.
- Background: PubMed 31284067Findlater 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.
- Background: PubMed 29196275Leta 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.
- Background: PubMed 30660556Ponce 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.
- Background: PubMed 20156059Schlagenhauf 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.
- Background: PubMed 14604928Schlagenhauf 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.
- Background: PubMed 23962447Tomasello 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.
- Derived from this study: PubMed 41260318Hedrich 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.
- Derived from this study: PubMed 39067885Lovey 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Epidemiology, Biostatistics and Prevention Institute at the University of Zurich
Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Travel-Related Illness and Malaria, run by Patricia Schlagenhauf at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of travel-related infectious diseases (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672577, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.