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RecruitingNCT07251049EMAI-NGSUpdated Nov 26, 2025

Acute Infectious Encephalitis and Myelitis in Guadeloupe by New Generation Sequencing

An observational study in Acute Encephalitis and Acute Myelitis, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 28 Days and older. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
28 Days and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Acute Encephalitis
  • Acute Myelitis

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Keywords

  • Acute Infectious encephalitis
  • myelitis
  • next generation sequencing
  • French West Indies
03

In context

Myelitis

13 studies on the registry are indexed under Myelitis; 3 are open to participants now.

Browse Myelitis studies →

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Primary vasculitis of the central nervous system or a documented specific impairment in an 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. neurotropic pathogen

    The detection of a neurotropic pathogen in the cerebrospinal fluid

    Time frame: baseline, 3 month (if necessary)

Secondary outcomes

  1. Neuro radiological

    Neuro radiological observations

    Time frame: baseline, 3 month, 12 month

  2. Bacteriological

    Bacteriological observations

    Time frame: baseline, 15 days , 3 months

  3. biochimical

    biochimical observations

    Time frame: baseline, 15 days, 3 months

  4. Clinical neurological

    Clinical neurological examination

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

  5. • Neuropsychological

    • Neuropsychological assessment

    Time frame: 3 months, 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for Nov 2028, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2025
First posted
Nov 26, 2025
StartActual
Nov 16, 2023
Primary completionEst.
Nov 16, 2028
CompletionEst.
Nov 16, 2028
Last update
Nov 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07251049
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Nov 16, 2023
Primary completion
Nov 16, 2028 (estimated)
Completion
Nov 16, 2028 (estimated)
Last update
Nov 26, 2025

Study contacts

Val"érie HAMONY-SOTER
Contact
valerie.soter@chu-guadeloupe.fr
+590 590 93 46 77
Eunice NUBRET
Contact
eunice.nubret@chu-guadeloupe.fr
0590934686
Hugo CHAUMONT, Doctor
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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