Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia with a Focus on Japanese Encephalitis Virus (DEMELE-JEV)

ANRS, Emerging Infectious Diseases

Status: Not yet enrolling

Conditions: Japanese Encephalitis

Study type: Observational

Funder types: Other

Identifiers

NCT06674837

ANRS0629s

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 contraindication for lumbar puncture (LP).

Trial design

4,000 participants in 2 patient groups

DEMELE-JEV Cohort 1

Description:

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

Description:

This group will include children aged 2-14 years who are hospitalized with febrile neurological syndrome (FNS)