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Not Yet RecruitingNCT06674837

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
4,000 (estimated)
Sponsor
ANRS, Emerging Infectious Diseases · Other Government
Sex
All
Age
2 Years – 14 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Timeline

Start date
2025-10-15
Primary completion
2027-01-01
Completion
2028-01-01
First posted
2024-11-05
Last updated
2025-09-11

Source: ClinicalTrials.gov record NCT06674837. Inclusion in this directory is not an endorsement.