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

NCT06674837 | Not Yet Recruiting

• 1 other identifier: ANRS0629s
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Japanese Encephalitis

Keywords

Japanese encephalitis; arbovirus

Outcome Measures

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

  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.

  12 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

see eligibility

You may qualify if:

• 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).

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and cerebrospinal fluid

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Diana Molino, PhD

CONTACT

+33 1 53 94 60 76; diana.molino@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 5, 2024
• Study Start: October 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09