SouthEast Asia Encephalitis Project

NCT04089436 | Unknown DMC

• 1 other identifier: 2013-024
• Study Type: observational
• Target: 800
• Locations: 4 countries
• Sites: 7

Brief Summary

Encephalitis, an acute inflammation of the central nervous system associated with neurologic dysfunction is of public health concern worldwide, because of its high mortality and neurological sequelae rates. In Asia where many of the possible etiologies are of major public health concerns (i.e. dengue, Japanese encephalitis, West Nile virus, EV71), acute encephalitis is among the most frequent and severe causes of pediatric hospitalization. Despite extensive microbiological investigations, no pathogen is identified for a significant proportion of encephalitis patients in both industrialized and developing countries (28-85% of cases remain unconfirmed). Unknown and sometimes new emerging infectious agents may be responsible for cases of currently unknown etiology and an intensive effort to identify and characterize them is to be done. From this perspective, the Southeast Asian region, a particularly significant biodiversity hotspot, is at high risk for new pathogen emergence. Surveillance and diagnostic capabilities for encephalitis remain poor and still suffer from serious shortcomings in most Southeast Asian countries and beyond. Although the burden of non-infectious encephalitis in this region remains to be ascertained, the best laboratories only identify etiological infective agents in less than half of patients. Systematic data regarding the contribution of these diseases are lacking and to define the burden of these infections, to describe the full clinical spectrum and characteristics of acute central nervous system infections, and to develop diagnostic and therapeutic algorithms to improve patient care. The proposed project is an ambitious and multidisciplinary research consortium that aims to reduce the morbidity and mortality associated with infectious encephalitis in Southeast Asia (Cambodia, Laos, Vietnam and Myanmar) by improving diagnosis and medical care for patients. The SEAe project specific objectives are:

• To fill-in the biomedical knowledge gaps regarding acute encephalitis syndrome;
• To strengthen hospital laboratories capacities to enhance health by improving diagnosis and care for patients;
• To identify unknown pathogens responsible for encephalitis;
• To provide reliable information and a sustainable regional and sub-regional surveillance network to clinicians and public health stakeholders that will help them to better define prevention policies, vaccination strategy, and build preparedness to emerging infectious risks.

Conditions

Encephalitis

Keywords

Encephalitis; Southeast Asia; Japanese encephalitis; Next Generation sequencing

Outcome Measures

Primary Outcomes (1)

• Identify etiologies of encephalitis in South East Asia (Vietnam, Laos, Cambodia and Myanmar).

  Proportion of patients with confirmed or probable etiologies and proportion with unidentified pathogen

  August 2019

Secondary Outcomes (3)

• Describe clinical and biological features of patients with encephalitis

  August 2019

• describe clinical outcomes of encephalitis in general and by etiology

  December 2019

• Identify factors associated with death or severe neurological sequelea in patients with confirmed infectious encephalitis (survival analyses, sequelea score).

  December 2019

Study Arms (1)

patients with encephalitis

children above 28days and adults with suspected encephalitis Hospitalized in 4 different Hospitals, Kantha Bopha IV children's Hospital, Phnom Penh, Cambodia, National paediatrics Hospital, Hanoi, Vietnam and Mahosot Hospital, Vientiane, Lao PDR, and Yangon Children Hospital, Yangon, Myanmar

Diagnostic Test: CSF sampling; Diagnostic Test: Blood sampling; Diagnostic Test: Nasopharyngeal and rectal sampling

Interventions

CSF sampling DIAGNOSTIC_TEST

CSF sampling by lumbar puncture

patients with encephalitis

Blood sampling DIAGNOSTIC_TEST

Blood sampling by blood test

patients with encephalitis

Nasopharyngeal and rectal sampling DIAGNOSTIC_TEST

Nasopharyngeal and rectal sample by swabbing

patients with encephalitis

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected encephalitis Hospitalized in 4 different Hospitals, Kantha Bopha IV children's Hospital, Phnom Penh, Cambodia, National paediatrics Hospital, Hanoi, Vietnam and Mahosot Hospital, Vientiane, Lao PDR, and Yangon Children Hospital, Yangon, Myanmar.

You may qualify if:

• presenting altered mental status (i.e. confusion or inability to talk, decreased or altered level of consciousness or personality change AND lasting 24 hours or more AND no alternative cause identified);
• presenting fever (38°C axillary) for less than 72 hours before or after presentation;
• seizure (febrile seizure excluded);
• focal neurologic finding.

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Pasteur: lead
• Centre De Coopération International En Recherche Agronomique Pour Le Développement: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Institut Pasteur, Cambodia: collaborator
• Institut de Recherche pour le Developpement: collaborator
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• University of Oxford: collaborator
• National Health Laboratory, Myanmar: collaborator

Study Sites (7)

National Health Laboratory

Yangon, Burma

Location

Yangon children hospital

Yangon, Burma

Location

Institut Pasteur of Cambodia

Phnom Penh, Cambodia

Location

Kantha Bopha IV children Hospital

Phnom Penh, Cambodia

Location

Mahidol Oxford Tropical Medicine Research Unit

Vientiane, Laos

Location

National Hospital of Pediatrics

Hanoi, Vietnam

Location

National Institute of Hygiene Epidemiology

Hanoi, Vietnam

Location

Related Publications (1)

• Pommier JD, Gorman C, Crabol Y, Bleakley K, Sothy H, Santy K, Tran HTT, Nguyen LV, Bunnakea E, Hlaing CS, Aye AMM, Cappelle J, Herrant M, Piola P, Rosset B, Chevalier V, Tarantola A, Channa M, Honnorat J, Pinto AL, Rattanavong S, Vongsouvath M, Mayxay M, Phangmanixay S, Phongsavath K, Tin OS, Kyaw LL, Tin HH, Linn K, Tran TMH, Perot P, Thuy NTT, Hien N, Phan PH, Buchy P, Dussart P, Laurent D, Eloit M, Dubot-Peres A, Lortholary O, de Lamballerie X, Newton PN, Lecuit M; SEAe Consortium. Childhood encephalitis in the Greater Mekong region (the SouthEast Asia Encephalitis Project): a multicentre prospective study. Lancet Glob Health. 2022 Jul;10(7):e989-e1002. doi: 10.1016/S2214-109X(22)00174-7.

  PMID: 35714649 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

CSF, Whole blood, Buffy Coat, nasopharyngeal and rectal specimen, urine, stool.

MeSH Terms

Conditions

Encephalitis; Encephalitis, Japanese

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marc LECUIT, MD, PhD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: September 13, 2019
• Study Start: July 15, 2014
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); VN (2); BU (2); LA (1)