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Acute EncephalitisEMAI-NGSNCT07251049

Acute Infectious Encephalitis and Myelitis in Guadeloupe by New Generation Sequencing

An observational study of Acute Encephalitis and Acute Myelitis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 days and older
Conditions the study is for
Acute Encephalitis, Acute Myelitis
How many people
100 participants
Where
1 siteGuadeloupe
Study dates
16 Nov 2023to 16 Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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
Show all 27Show fewer
  • 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);

Who cannot join

  • 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
Show all 9Show fewer
  • Toxic or metabolic encephalopathy
  • Transverse myelitis with vascular or traumatic origin
  • Known chronic infection with HTLV virus

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Val"érie HAMONY-SOTER contact

+590 590 93 46 77

valerie.soter@chu-guadeloupe.fr

Eunice NUBRET contact

0590934686

eunice.nubret@chu-guadeloupe.fr

Guadeloupe1 site, 1 recruiting

  • Centre Hospitalier Universitaire de la Guadeloupe

    Pointe-à-Pitre, Guadeloupe, 97159

    Valérie HAMONY-SOTER, +590590934686, valerie.soter@chu-guadeloupe.fr

    Eunice NUBRET, 0590934686, eunice.nubret@chu-guadeloupe.fr

    Recruiting

Other trials in Guadeloupe

About this study

Official title: 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.

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

Keywords
Acute Infectious encephalitis, myelitis, next generation sequencing, French West Indies
Medical subject headings
Myelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07251049
Study groupRoleWhat they receive
Encephalitis or myelitisPatients diagnosed with encephalitis or myelitis are defined as having an inflammatory or infectious involvement of the cerebral parenchyma or the spinal cord.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. neurotropic pathogen

    The detection of a neurotropic pathogen in the cerebrospinal fluid

    Measured: baseline, 3 month (if necessary)

Secondary outcomes (5)

  1. Neuro radiological

    Neuro radiological observations

    Measured: baseline, 3 month, 12 month

  2. Bacteriological

    Bacteriological observations

    Measured: baseline, 15 days , 3 months

  3. biochimical

    biochimical observations

    Measured: baseline, 15 days, 3 months

  4. Clinical neurological

    Clinical neurological examination

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

  5. • Neuropsychological

    • Neuropsychological assessment

    Measured: 3 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start16 Nov 2023
  3. Primary completion16 Nov 2028 (estimated)
  4. Study completion16 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07251049
Sponsor's protocol ID
PAP_RI2_2019/10
Acronym
EMAI-NGS
Status last verified
Oct 2025
First submitted
14 Nov 2025
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Encephalitis and Acute Myelitis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Val"érie HAMONY-SOTER (+590 590 93 46 77, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

neurotropic pathogen (time frame: baseline, 3 month (if necessary)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07251049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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