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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-14
SponsorANRS, Emerging Infectious Diseases

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

see eligibility

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 2 trial groups
Group A: DEMELE-JEV Cohort 1
Group B: DEMELE-JEV Cohort 2

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: