Clinical trial NCT06674837: Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Official title: Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Japanese Encephalitis
Keywords: Japanese encephalitis
arbovirus
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2024-11-05
Enrollment: 4000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: see eligibility

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.

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.

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).

Primary outcomes:
measure: To quantify Japanese Encephalitis Virus seroconversion in a cohort of asymptomatic children aged 2-14 years
timeFrame: 24 months
Secondary outcomes:
measure: To assess factors related to the clinical severity of JEV infection among children hospitalized with febrile neurological symptoms (FNS) who are confirmed JEV cases.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: