Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Japanese Encephalitis. Basic parameters: 2 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- To quantify Japanese Encephalitis Virus seroconversion in a cohort of asymptomatic children aged 2-14 years [Time frame: 24 months]
Secondary outcome measures (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. [Time frame: 12 months]
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 contraindication for lumbar puncture (LP).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06674837 · ANRS0629s