ClinicalTrials.gg
Not yet recruitingNCT06674837DEMELE-JEVUpdated Sep 11, 2025

Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus

An observational study in Japanese Encephalitis, sponsored by ANRS, Emerging Infectious Diseases. Not yet recruiting. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by ANRS, Emerging Infectious Diseases · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
2 Years to 14 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Japanese Encephalitis

Browse trials for

Keywords

  • Japanese encephalitis
  • arbovirus
03

In context

Encephalitis, Japanese

74 studies on the registry are indexed under Encephalitis, Japanese; 3 are open to participants now.

Browse Encephalitis, Japanese studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

see eligibility

Eligibility criteria

Inclusion Criteria:

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.

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 for lumbar puncture (LP).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Cambdodia local reglementation will decide de IPD

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06674837
Responsible party
Sponsor
First posted
Nov 5, 2024
Start date
Oct 15, 2025 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Sep 11, 2025

Study contacts

Diana Molino, PhD
Contact
diana.molino@inserm.fr
+33 1 53 94 60 76

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion