Japanese EncephalitisDEMELE-JEVNCT06674837
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
An observational study of Japanese Encephalitis, run by ANRS, Emerging Infectious Diseases.
Trial summary
The primary objective of this study is to quantify the clinical burden of Japanese Encephalitis (JE) and the asymptomatic circulation of JEV among Cambodian children, through two pediatric cohorts: non-febrile children at recruitment and children hospitalized with febrile neurological syndrome (FNS). Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to Jan 2028
- 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 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: see eligibility
Who may be able to join
- Cohort 1
- All children aged between 2 and 14 years.
- No fever or history of fever in the past 14 days.
- Consenting to return to the hospital for follow-up visits.
- Consenting to blood sampling.
- Written informed assent/consent to participate in the study.
Show all 12Show fewer
- Cohort 2
- Hospitalized patients aged between 2 and 14 years.
- Any neurological disorder.
- Any fever within the past 72 hours.
- Written informed assent/consent to participate in the study.
- No contraindication for lumbar puncture (LP).
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The primary objective of this study is to quantify the clinical burden of Japanese Encephalitis (JE) and the asymptomatic circulation of JEV among Cambodian children, through two pediatric cohorts: non-febrile children at recruitment and children hospitalized with febrile neurological syndrome (FNS). Secondary objectives include estimating anti-JEV seropositivity rates, identifying individual risk factors and living conditions associated with JEV infection, characterizing clinical and biological profiles related to disease severity, and evaluating the role of deficiencies in interferon (IFN) response in severe JEV infections.
Read the detailed description
This is an observational prospective study (with cross-sectional and longitudinal designs) involving two pediatric cohorts recruited from Kantha Bopha hospitals in Phnom Penh and Siem Reap. Group 1 will consist of 2000 non-febrile children aged 2-14 years, recruited from trauma units and followed up for two years to monitor JEV seroconversion. Group 2 will include 2000 children hospitalized with FNS, confirmed JE participants will be followed up for one year to assess the severity of JEV infection. Diagnostic tools such as the QIAstat molecular diagnostic platform and ELISA will be used to detect multiple pathogens, including JEV and dengue virus (DENV). Data collection will involve clinical assessments, etiological testing, and environmental surveys. All collected information will be integrated into a centralized database for analysis.
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese encephalitis, arbovirus
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DEMELE-JEV Cohort 1 | This group will include children aged 2-14 years who present at the hospital for reasons other than infectious disease suspicion. During the study of the project, 2000 children will be recruited at each study site. All these children will be followed up at one year and two years post-inclusion | |
| DEMELE-JEV Cohort 2 | This group will include children aged 2-14 years who are hospitalized with febrile neurological syndrome (FNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify Japanese Encephalitis Virus seroconversion in a cohort of asymptomatic children aged 2-14 years
Japanese Encephalitis Virus seroconversion will be determined based on PCR positivity or ELISA results, with confirmatory testing by virus neutralization assays.
Unit of Measure: Binary measure (presence or absence) of JEV antibodies or presence of JEV RNA
Measured: 24 months
Secondary outcomes (1)
To assess factors related to the clinical severity of JEV infection among children hospitalized with febrile neurological symptoms (FNS) who are confirmed JEV cases.
Severity will be evaluated based on the following clinical indicators:
- Length of hospital stay (measured in days).
- Presence of neurological sequelae (binary outcome: presence or absence).
- Mortality (binary outcome: survival or death). Unit of Measure: Days for hospitalization length; binary measures for sequelae and mortality.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Oct 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674837
- Sponsor's protocol ID
- ANRS0629s
- Acronym
- DEMELE-JEV
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cambdodia local reglementation will decide de IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
- ClinicalTrials.gov ID
- NCT06674837
- Acronym / sponsor ID
- DEMELE-JEV / ANRS0629s
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese encephalitis, arbovirus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Nov 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.
The primary objective of this study is to quantify the clinical burden of Japanese Encephalitis (JE) and the asymptomatic circulation of JEV among Cambodian children, through two pediatric cohorts: non-febrile children at recruitment and children hospitalized with febrile neurological syndrome (FNS). Secondary objectives include estimating anti-JEV seropositivity rates, identifying individual risk factors and living conditions associated with JEV infection, characterizing clinical and biological profiles related to disease severity, and evaluating the role of deficiencies in interferon (IFN) response in severe JEV infections.
Detailed description
This is an observational prospective study (with cross-sectional and longitudinal designs) involving two pediatric cohorts recruited from Kantha Bopha hospitals in Phnom Penh and Siem Reap. Group 1 will consist of 2000 non-febrile children aged 2-14 years, recruited from trauma units and followed up for two years to monitor JEV seroconversion. Group 2 will include 2000 children hospitalized with FNS, confirmed JE participants will be followed up for one year to assess the severity of JEV infection. Diagnostic tools such as the QIAstat molecular diagnostic platform and ELISA will be used to detect multiple pathogens, including JEV and dengue virus (DENV). Data collection will involve clinical assessments, etiological testing, and environmental surveys. All collected information will be integrated into a centralized database for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEMELE-JEV Cohort 1 | – | –This group will include children aged 2-14 years who present at the hospital for reasons other than infectious disease suspicion. During the study of the project, 2000 children will be recruited at each study site. All these children will be followed up at one year and two years post-inclusion |
| DEMELE-JEV Cohort 2 | – | –This group will include children aged 2-14 years who are hospitalized with febrile neurological syndrome (FNS) |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- see eligibility
Key inclusion criteria (12 listed)
- Cohort 1
- All children aged between 2 and 14 years.
- No fever or history of fever in the past 14 days.
- Consenting to return to the hospital for follow-up visits.
- Consenting to blood sampling.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To quantify Japanese Encephalitis Virus seroconversion in a cohort of asymptomatic children aged 2-14 years
Time frame: 24 months
Japanese Encephalitis Virus seroconversion will be determined based on PCR positivity or ELISA results, with confirmatory testing by virus neutralization assays. Unit of Measure: Binary measure (presence or absence) of JEV antibodies or presence of JEV RNA
1 secondary outcome
To assess factors related to the clinical severity of JEV infection among children hospitalized with febrile neurological symptoms (FNS) who are confirmed JEV cases.
Time frame: 12 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 11 Sep 2025.
- Individual participant dataSharing planned: Undecided. Cambdodia local reglementation will decide de IPD
Related trials for Japanese Encephalitis
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Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Japanese Encephalitis, run by ANRS, Emerging Infectious Diseases.
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 12 inclusion and 0 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: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Diana Molino, PhD (+33 1 53 94 60 76, diana.molino@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify Japanese Encephalitis Virus seroconversion in a cohort of asymptomatic children aged 2-14 years (time frame: 24 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 11 Sep 2025.