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

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.

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 contraindication for lumbar puncture (LP).

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Molino, PhD

CONTACT

[email protected]

+33 1 53 94 60 76

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Acronym: DEMELE-JEV

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Nov 5, 2024
Registry last updated: Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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