Acute Infectious Encephalitis and Myelitis in Guadeloupe by New Generation Sequencing (EMAI-NGS)

Acute Infectious Encephalitis and Myelitis in Guadeloupe by New Generation Sequencing Acute Infectious Encephalitis and Myelitis in Guadeloupe by New Generation Sequencing

: Encephalitis or myelitis is defined as the inflammatory or infectious involvement of the cerebral parenchyma or spinal cord. When an infectious origin is suspected, the germ is not always identified. Next-generation sequencing could be used to correct an etiological diagnosis of these severe conditions in Guadeloupe. The rate of cases for which the infectious agent is not identified encourages continued diagnostic efforts, with the objective of identifying new pathogens or emerging pathogens, some of which may be more specific in the tropics.

Study Overview

• Status: Recruiting
• Conditions: Acute Encephalitis; Acute Myelitis

Detailed Description

Encephalitis or myelitis is defined as the inflammatory or infectious involvement of the cerebral parenchyma or spinal cord. When an infectious origin is suspected, the germ is not always identified. In Guadeloupe, a region exposed to arboviruses, these infectious agents are among the causes of acute infectious attacks of the central nervous system. Other bacteria, parasites, or poorly known fungal agents may be responsible for these conditions. An observational study, retrospective over a period of 4 years, carried out at University Hospital of Guadeloupe, on cases of acute infectious attacks of the central nervous system, showed that the pathogen was not found in 45% of cases. Next Generation Sequencing (NGS) allows DNA or RNA sequencing faster and more accurately than other routine methods (serology / PCR). This technique could be used to correct an etiological diagnosis concerning these severe conditions in Guadeloupe, as part of a prospective study. Indeed, we find in the literature, more and more examples of patients suffering from these conditions of origin called "indeterminate", for which an etiological diagnosis is made thanks to the NGS, and sometimes a suitable curative treatment undertaken in the course of. A study of this type would be necessary to obtain exhaustive epidemiological data and to improve understanding of these severe pathologies, the consequences of which, in the short and long term, represent real public health issues. The main objective of the study is to describe, prospectively, the etiologies of acute encephalitis and myelitis at the University Hospital of Guadeloupe by carrying out diagnostic methods which may include NGS in patients without etiological diagnosis after having benefited from a first-line assessment. The secondary objectives are to describe the clinical, paraclinical and epidemiological characteristics of these conditions, and to describe long term outcomes

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eunice NUBRET; Phone Number: 0590934686; Email: eunice.nubret@chu-guadeloupe.fr
• Study Contact Backup: Name: Val"érie HAMONY-SOTER; Phone Number: +590 590 93 46 77; Email: valerie.soter@chu-guadeloupe.fr

Study Locations

• Guadeloupe
  • Guadeloupe
    • Pointe-à-Pitre, Guadeloupe, Guadeloupe, 97159
      • Recruiting
      • Centre Hospitalier Universitaire de la Guadeloupe
      • Contact: Valérie HAMONY-SOTER; Phone Number: +590590934686; Email: valerie.soter@chu-guadeloupe.fr
      • Contact: Eunice NUBRET; Phone Number: 0590934686; Email: eunice.nubret@chu-guadeloupe.fr
      • Principal Investigator: Hugo CHAUMONT, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected acute infectious encephalitis and / or myelitis, according to the clinical and paraclinical criteria described in recommendations of the International Encephalitis Consortium in 2013 and the by the Transverse Myelitis Consortium Working Group in 2002

Description

Inclusion Criteria:

• We selected the following eligibility criteria for patients with acute encephalitis:

  • Patient of at least 28 days of life
  • With acute onset of symptoms for more than 24 hours
  • A major criterion among the following:
• a disorder of consciousness or alertness
• memory disorder
• lethargy
• modification of personal or behavioral disorder, irritability

• confusion, disorientation in time or space

  - At least two of the following minor criteria:

• temperature above 38 ° C
• new onset focal neurological deficit
• epileptic crisis
• biological abnormality of CSF (≥ 5 Leukocytes / mm3, protein ≥ 0.40 g / L)
• partial or general epileptic seizure (s) not attributable to pre-existing epileptic disease and / or a recent focal neurological symptom

• brain imaging suggestive of encephalitis, with EEG abnormalities suggestive of encephalitis

  • And absence of alternative diagnosis (intoxication, metabolic encephalopathy)
  • Persons affiliated or benefiting from a social security scheme;
  • Having given free, informed, written and signed consent by the patient or his legal representative (no later than the day of inclusion and prior to any review required by the research);

• Eligibility criteria for Acute Transverse Myelitis Patients:

  • Patient of at least 28 days of life
  • Acute onset of symptoms for more than 24 hours
  • Medullary focal abnormality, responsible for motor, sensory or autonomic symptoms
  • contrast enhancement on bone marrow MRI and / or abnormal CSF (≥ 5GB / mm3, protein uptake ≥ 0.40 g / L)
  • Evolution between nadir and maximum symptoms, less than 4 weeks
  • Persons affiliated or benefiting from a social security scheme;
  • Having given free, informed, written and signed consent by the patient or his legal representative (no later than the day of inclusion and prior to any review required by the research);

Exclusion Criteria:

• Primary vasculitis of the central nervous system or a documented specific impairment in an autoimmune condition
• Cerebral thrombophlebitis if not associated with encephalitis
• Meningitis without clinical or paraclinical argument for cerebral parenchymal involvement
• Pyogenic abscess
• Cerebral or spinal abscess
• Tumoral or hematological pathology of the central nervous system
• Toxic or metabolic encephalopathy
• Transverse myelitis with vascular or traumatic origin
• Known chronic infection with HTLV virus

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Encephalitis or myelitis; Patients diagnosed with encephalitis or myelitis are defined as having an inflammatory or infectious involvement of the cerebral parenchyma or the spinal cord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurotropic pathogen	The detection of a neurotropic pathogen in the cerebrospinal fluid	baseline, 3 month (if necessary)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuro radiological	Neuro radiological observations	baseline, 3 month, 12 month
Bacteriological	Bacteriological observations	baseline, 15 days , 3 months
biochimical	biochimical observations	baseline, 15 days, 3 months
Clinical neurological	Clinical neurological examination	at day 0, at hospital discharge or maximum on the 15th day (+/- 30 days), and 3 months, 12 months
• Neuropsychological	• Neuropsychological assessment	3 months, 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe
• Investigators: Principal Investigator: Hugo CHAUMONT, Doctor, CHU de la Guadeloupe

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): November 16, 2028
• Study Completion (Estimated): November 16, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: next generation sequencing; French West Indies; myelitis; Acute Infectious encephalitis
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Spinal Cord Diseases; Central Nervous System Infections; Myelitis
• Other Study ID Numbers: PAP_RI2_2019/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No