Arbovirus InfectionsNCT06651372
The Interest of Systematic Screening for Dengue, Chikungunya, and Zika, in Malaria-negative Return Travelers
An observational study of Arbovirus Infections, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
International travel has increased dramatically in recent years. Vector-borne pathologies such as malaria and arboviruses are common etiologies of post-travel fever, which are prevalent in similar geographical areas (tropical and intertropical). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arbovirus Infections
- What is being tested?
- The retrospective analyses planned for these samples consist of serological analysis and molecular analysis (RT-PCR ) according to the date of symptoms ons
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any person, man or woman, aged over 18, treated at the University Hospitals of Strasbourg from January 2024 to December 2025, having received a blood sample as part of the treatment, for a diagnosis of malaria upon return from a recent trip whose result was negative. Any person who has already consented or has not objected to their biological resources being preserved in the "Microbiology" biocollection and reused for scientific research.
Who may be able to join
- Adult subject (≥18 years old), man or woman
- Supported at Strasbourg University Hospital between 01/01/2024 and 12/31/2025
- Having received a blood sample as part of the treatment for which the test for malaria was negative, following a recent return from a trip (≤ 31 days)
- Having already given their consent for their biological resources to be preserved in the "Microbiology" biocollection and reused for scientific research purposes.
Who cannot join
- Minor subject (< 18 years old)
- Adult patient for whom a test for malaria came back positive during initial treatment
- Patient having expressed his opposition to participating in the study
- Inability to provide the subject with informed information (subject in an emergency situation, difficulty understanding the subject, etc.)
- Subject under judicial protection
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie
Strasbourg, 67 000
About this study
Official title: Interest of Systematic Screening for Dengue, Chikungunya, and Zika, in Patients for Whom a Malaria Diagnosis is Negative, in the Event of a Recent Return From Travel: a Retrospective Study at the University Hospitals of Strasbourg, 2024-2025
International travel has increased dramatically in recent years. Vector-borne pathologies such as malaria and arboviruses are common etiologies of post-travel fever, which are prevalent in similar geographical areas (tropical and intertropical). Arboviruses, for "arthropod-borne viruses," are transmitted by the bite of blood-sucking vectors (mosquitoes, ticks, or sandflies). The dengue, chikungunya, and zika viruses are transmitted through the bite of an infected Aedes mosquito (Aedes aegypti and Aedes albopictus).
The establishment of Aedes albopictus (tiger mosquito), competent for transmitting these 3 viruses, since 2004 in mainland France and the transit of travelers carrying a virus allowed the appearance of the first autochthonous cases of dengue and zika. Each year, outbreaks of autochthonous cases of dengue fever are reported in the PACA, Occitanie, and Auvergne-Rhône Alpes regions, and a cluster of 3 Indigenous cases was reported in 2023 in the Paris region.
Read more
Since 2014, the tiger mosquito has been established in Bas-Rhin. Between 2014 and 2022, the vector was detected in around thirty municipalities around Strasbourg. In a department where the spread of the tiger mosquito is evolving rapidly, these data remind us that only an early diagnosis, delivered quickly, allows effective vector control measures to avoid generating autochthonous transmission.
In a previous study carried out at the Virology laboratory, we retrospectively analyzed the diagnosis of these 3 arboviruses after the exclusion of malaria in the context of recent travel over a period of 10 years (2014-2023). Among the 913 patients included, for 78% of cases (n=714), no testing for dengue, chikungunya, or zika was carried out, a proportion stable over 10 years.
These three arboviruses seem underdiagnosed, and we assume, given our previous results, that 8 to 10% of patients for whom, in the context of recent travel, a test for malaria comes back negative are imported cases of dengue, chikungunya, or zika. At the end of this retrospective study, we want to evaluate this sub-diagnosis on a larger sample to propose a review of practices and the establishment of Arbovirus-malaria "reflex testing." Currently, no French or similar European data is available, allowing us to evaluate this under-diagnosis, which constitutes a significant risk of the emergence of indigenous clusters in our territory.
The main objective of this study is to determine the infection rate by dengue, chikungunya, and zika viruses identified when the diagnosis is made after the exclusion of negative malaria in the context of recent travel among patients treated at the Strasbourg University Hospitals between January 1, 2024, and December 31, 2025.
The secondary objectives of this work are as follows:
Estimate the prevalence of different clinical symptoms (patient medical records) in retrospectively identified cases of dengue, chikungunya, and zika.
- Evaluate the onset time of symptoms in relation to the date of return/arrival from the area of stay of retrospectively identified cases of dengue, chikungunya, and zika.
- Evaluate the delay in the appearance of symptoms in relation to the date of taking the initial sample (the one leading to the diagnosis of negative malaria) of retrospectively identified cases of dengue, chikungunya, and zika.
- Study the laboratory results associated with the initial management of the patient (biochemical assessment and blood count) of retrospectively identified cases of dengue, chikungunya, and zika.
- Study the distribution of areas, periods, and reasons for staying in retrospectively identified dengue, chikungunya, and zika cases.
Study the municipalities of residence of positive cases in the areas where the tiger mosquito is established.
- Conditions
- Arbovirus Infections
- Being tested
- The retrospective analyses planned for these samples consist of serological analysis and molecular analysis (RT-PCR ) according to the date of symptoms ons
- Keywords
- Post-travel infections, Dengue, Chikungunya, Zika disease, Arbovirus screening
- Medical subject headings
- Arbovirus Infections, Dengue, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The retrospective analyses planned for these samples consist of serological analysis and molecular analysis (RT-PCR ) according to the date of symptoms onsBiological
Serological tests detecting IgM and IgG
| Study group | Role | What they receive |
|---|---|---|
| Malaria negative return travelers | Any person, man or woman, aged over 18, treated at the University Hospitals of Strasbourg from January 2024 to December 2025, having received a blood sample as part of the treatment, for a diagnosis of malaria upon return from a recent trip whose result was negative. Any person who has already consented or has not objected to their biological resources being preserved in the "Microbiology" biocollection and reused for scientific research. Receives: Biological: The retrospective analyses planned for these samples consist of serological analysis and molecular analysis (RT-PCR ) according to the date of symptoms ons |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of dengue virus, zika virus, or chikungunya virus infection in samples from the subjects studied.
Patients and samples will be selected based on diagnostic activity data from the Medical Mycology Parasitology laboratory. The corresponding production statistics will be produced using the laboratory information system (LIS), glims software from 01/01/2024 to 12/31/2025.
The retrospective analyses planned for these samples will all be carried out within the microbiology technical platform by the Virology laboratory without any sample transfer.
Serological tests detecting IgM and IgG will be carried out using the following commercial ELISA kits:
- Vidas® Anti-chikungunya IgM and IgG
- Vidas® Anti-dengue IgM and IgG
- Virclia® Anti-Zika IgM and IgG NS1 antigen detection will be carried out using the Abbott® Bioline Dengue duo test.
RT-PCR will be carried out using the following kits: EVAg Primers, Probes (Lyoph-P\&P) and Positive control for dengue virus detection, chikungunya virus detection and zika virus detection (adapted to Hologic PantherFusion OpenAccess).
Measured: 36 months
Secondary outcomes (1)
Distribution of the clinical symptoms and the biological findings
To estimate the prevalence of different clinical symptoms (patient medical records) in retrospectively identified cases of dengue, chikungunya and zika.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Aug 2025
- Primary completion1 Aug 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651372
- Sponsor's protocol ID
- IV-0198
- Status last verified
- Aug 2025
- First submitted
- 17 Oct 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Systematic Screening for Dengue, Chikungunya, and Zika, in Patients for Whom a Malaria Diagnosis is Negative, in the Event of a Recent Return From Travel: a Retrospective Study at the University Hospitals of Strasbourg, 2024-2025
- ClinicalTrials.gov ID
- NCT06651372
- Acronym / sponsor ID
- IV-0198
- Conditions
- Arbovirus Infections
- Keywords
- Post-travel infections, Dengue, Chikungunya, Zika disease, Arbovirus screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Oct 2024 (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.
International travel has increased dramatically in recent years. Vector-borne pathologies such as malaria and arboviruses are common etiologies of post-travel fever, which are prevalent in similar geographical areas (tropical and intertropical). Arboviruses, for "arthropod-borne viruses," are transmitted by the bite of blood-sucking vectors (mosquitoes, ticks, or sandflies). The dengue, chikungunya, and zika viruses are transmitted through the bite of an infected Aedes mosquito (Aedes aegypti and Aedes albopictus).
The establishment of Aedes albopictus (tiger mosquito), competent for transmitting these 3 viruses, since 2004 in mainland France and the transit of travelers carrying a virus allowed the appearance of the first autochthonous cases of dengue and zika. Each year, outbreaks of autochthonous cases of dengue fever are reported in the PACA, Occitanie, and Auvergne-Rhône Alpes regions, and a cluster of 3 Indigenous cases was reported in 2023 in the Paris region.
Since 2014, the tiger mosquito has been established in Bas-Rhin. Between 2014 and 2022, the vector was detected in around thirty municipalities around Strasbourg. In a department where the spread of the tiger mosquito is evolving rapidly, these data remind us that only an early diagnosis, delivered quickly, allows effective vector control measures to avoid generating autochthonous transmission.
In a previous study carried out at the Virology laboratory, we retrospectively analyzed the diagnosis of these 3 arboviruses after the exclusion of malaria in the context of recent travel over a period of 10 years (2014-2023). Among the 913 patients included, for 78% of cases (n=714), no testing for dengue, chikungunya, or zika was carried out, a proportion stable over 10 years.
These three arboviruses seem underdiagnosed, and we assume, given our previous results, that 8 to 10% of patients for whom, in the context of recent travel, a test for malaria comes back negative are imported cases of dengue, chikungunya, or zika. At the end of this retrospective study, we want to evaluate this sub-diagnosis on a larger sample to propose a review of practices and the establishment of Arbovirus-malaria "reflex testing." Currently, no French or similar European data is available, allowing us to evaluate this under-diagnosis, which constitutes a significant risk of the emergence of indigenous clusters in our territory.
The main objective of this study is to determine the infection rate by dengue, chikungunya, and zika viruses identified when the diagnosis is made after the exclusion of negative malaria in the context of recent travel among patients treated at the Strasbourg University Hospitals between January 1, 2024, and December 31, 2025.
The secondary objectives of this work are as follows:
Estimate the prevalence of different clinical symptoms (patient medical records) in retrospectively identified cases of dengue, chikungunya, and zika.
- Evaluate the onset time of symptoms in relation to the date of return/arrival from the area of stay of retrospectively identified cases of dengue, chikungunya, and zika.
- Evaluate the delay in the appearance of symptoms in relation to the date of taking the initial sample (the one leading to the diagnosis of negative malaria) of retrospectively identified cases of dengue, chikungunya, and zika.
- Study the laboratory results associated with the initial management of the patient (biochemical assessment and blood count) of retrospectively identified cases of dengue, chikungunya, and zika.
- Study the distribution of areas, periods, and reasons for staying in retrospectively identified dengue, chikungunya, and zika cases.
Study the municipalities of residence of positive cases in the areas where the tiger mosquito is established.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malaria negative return travelers | – | Biological: The retrospective analyses planned for these samples consist of serological analysis and molecular analysis (RT-PCR ) according to the date of symptoms onsAny person, man or woman, aged over 18, treated at the University Hospitals of Strasbourg from January 2024 to December 2025, having received a blood sample as part of the treatment, for a diagnosis of malaria upon return from a recent trip whose result was negative. Any person who has already consented or has not objected to their biological resources being preserved in the "Microbiology" biocollection and reused for scientific research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person, man or woman, aged over 18, treated at the University Hospitals of Strasbourg from January 2024 to December 2025, having received a blood sample as part of the treatment, for a diagnosis of malaria upon return from a recent trip whose result was negative. Any person who has already consented or has not objected to their biological resources being preserved in the "Microbiology" biocollection and reused for scientific research.
Key inclusion criteria (4 listed)
- Adult subject (≥18 years old), man or woman
- Supported at Strasbourg University Hospital between 01/01/2024 and 12/31/2025
- Having received a blood sample as part of the treatment for which the test for malaria was negative, following a recent return from a trip (≤ 31 days)
- Having already given their consent for their biological resources to be preserved in the "Microbiology" biocollection and reused for scientific research purposes.
Key exclusion criteria (6 listed)
- Minor subject (< 18 years old)
- Adult patient for whom a test for malaria came back positive during initial treatment
- Patient having expressed his opposition to participating in the study
- Inability to provide the subject with informed information (subject in an emergency situation, difficulty understanding the subject, etc.)
- Subject under judicial protection
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 |
|---|---|---|
| The retrospective analyses planned for these samples consist of serological analysis and molecular analysis (RT-PCR ) according to the date of symptoms onsSerological tests detecting IgM and IgG | Biological | Malaria negative return travelers |
Primary outcome
The detection rate of dengue virus, zika virus, or chikungunya virus infection in samples from the subjects studied.
Time frame: 36 months
Patients and samples will be selected based on diagnostic activity data from the Medical Mycology Parasitology laboratory. The corresponding production statistics will be produced using the laboratory information system (LIS), glims software from 01/01/2024 to 12/31/2025. The retrospective analyses planned for these samples will all be carried out within the microbiology technical platform by the Virology laboratory without any sample transfer. Serological tests detecting IgM and IgG will be carried out using the following commercial ELISA kits: * Vidas® Anti-chikungunya IgM and IgG * Vidas® Anti-dengue IgM and IgG * Virclia® Anti-Zika IgM and IgG NS1 antigen detection will be carried out using the Abbott® Bioline Dengue duo test. RT-PCR will be carried out using the following kits: EVAg Primers, Probes (Lyoph-P\&P) and Positive control for dengue virus detection, chikungunya virus detection and zika virus detection (adapted to Hologic PantherFusion OpenAccess).
1 secondary outcome
Distribution of the clinical symptoms and the biological findings
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arbovirus Infections, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of dengue virus, zika virus, or chikungunya virus infection in samples from the subjects studied. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.