NCT07251049

Brief Summary

: 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Nov 2023Nov 2028

Study Start

First participant enrolled

November 16, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2028

Last Updated

November 26, 2025

Status Verified

October 1, 2025

Enrollment Period

5 years

First QC Date

November 14, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Acute Infectious encephalitismyelitisnext generation sequencingFrench West Indies

Outcome Measures

Primary Outcomes (1)

  • neurotropic pathogen

    The detection of a neurotropic pathogen in the cerebrospinal fluid

    baseline, 3 month (if necessary)

Secondary Outcomes (5)

  • Neuro radiological

    baseline, 3 month, 12 month

  • Bacteriological

    baseline, 15 days , 3 months

  • biochimical

    baseline, 15 days, 3 months

  • Clinical neurological

    at day 0, at hospital discharge or maximum on the 15th day (+/- 30 days), and 3 months, 12 months

  • • Neuropsychological

    3 months, 12 months

Study Arms (1)

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.

Eligibility Criteria

Age28 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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
  • +10 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloupe

Pointe-à-Pitre, Guadeloupe, 97159, Guadeloupe

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid, blood, urinary

MeSH Terms

Conditions

Myelitis

Condition Hierarchy (Ancestors)

Central Nervous System InfectionsInfectionsCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Officials

  • Hugo CHAUMONT, Doctor

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 26, 2025

Study Start

November 16, 2023

Primary Completion (Estimated)

November 16, 2028

Study Completion (Estimated)

November 16, 2028

Last Updated

November 26, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations