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

November 18, 2025 updated by: Centre Hospitalier Universitaire de la Guadeloupe

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Guadeloupe
    • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe, Guadeloupe, 97159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
neurotropic pathogen
Time Frame: baseline, 3 month (if necessary)
The detection of a neurotropic pathogen in the cerebrospinal fluid
baseline, 3 month (if necessary)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuro radiological
Time Frame: baseline, 3 month, 12 month
Neuro radiological observations
baseline, 3 month, 12 month
Bacteriological
Time Frame: baseline, 15 days , 3 months
Bacteriological observations
baseline, 15 days , 3 months
biochimical
Time Frame: baseline, 15 days, 3 months
biochimical observations
baseline, 15 days, 3 months
Clinical neurological
Time Frame: at day 0, at hospital discharge or maximum on the 15th day (+/- 30 days), and 3 months, 12 months
Clinical neurological examination
at day 0, at hospital discharge or maximum on the 15th day (+/- 30 days), and 3 months, 12 months
• Neuropsychological
Time Frame: 3 months, 12 months
• Neuropsychological assessment
3 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de la Guadeloupe

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hugo CHAUMONT, Doctor, CHU de la Guadeloupe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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