NCT03378882

Brief Summary

Hospitals in the French West Indies (Fort-de-France (Martinique); Basse-Terre and Pointe-à-Pitre (Guadeloupe); and French Guiana (Cayenne, Saint-Laurent du Maroni)) have noted the emergence of eosinophilic meningitis cases in recent years. This finding is part os eosinophilic meningitis cases emergence and meningoencephalitis caused by the parasite Angiostrongylus cantonensis on the American continent and in the Greater Antilles. In 2013, the investigation of an eosinophilic meningitis case by the Basse-Terre hospital team with a positive specific PCR in the CSF (CDC, Atlanta, USA) showed the first case of neuromeningeal angiostrongylosis in Guadeloupe. A similar case was diagnosed by serology at Pointe-à-Pitre University Hospital a few years earlier without having been published, and another serious case diagnosed also at Pointe-à-Pitre University Hospital Center in January 2017. The team at the Martinique University Hospital Center also reported several cases of eosinophilic meningitis with positive serologies for A. cantonensis carried out in laboratories outside Martinique (Laboratory of Parasitology, Gonesse, France; Thailand; and Tropical Institute and Public Health, Switzerland) in recent years. The emergence of this parasitosis is related to the introduction of the intermediate host Achatina fulica on the American continent and the geographical evolution of the angiostrongylosis cases is intrinsically linked to that of the Achatins. To date, only two studies report the environmental presence of Angiostrongylus cantonensis in the Lesser Antilles. One proved the presence in rats (23.4%) on the island of Grenada, and the other in Guadeloupe, showing that 32.4% of Achatina fulica collected carried the parasite by specific PCR. In Martinique, where the number of cases is increasing, and in French Guiana, where there is an increase in the number of cases in neighboring countries, especially Brazil, no study has been conducted on this parasite. In parallel with this finding, several serious digestive tables associated with strong hypereosinophilia were reported in Martinique and Guadeloupe in the 90s but also in recent years, the last case in December 2016. Etiological diagnoses were established by the discovery of Angiostrongylus costaricensis parasite in ileal pathological specimens. However, these cases could never be investigated by serology or specific PCR due to lack of diagnostic tools available in the French West Indies and Guiana region, and more broadly in metropolitan France.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

December 7, 2017

Last Update Submit

December 10, 2020

Conditions

Keywords

AngiostrongylosisHypereosinophiliaEosinophilic meningitisMeningoencephalitisAchatina fulicaAngiostrongylus cantonensisAngiostrongylus costaricensis

Outcome Measures

Primary Outcomes (2)

  • Number of participants with angiostrongylosis A. cantonensis

    The crude incidence will be calculated: Reported number of cases of angiostrongylosis A. cantonensis diagnosed during the study inclusion period (3 years) on the total population (population census data). The number of human cases of angiostrongylosis A. cantonensis diagnosed since the emergence of the parasite in the West Indies and Guiana will be calculated. The standardized incidence (on age and sex) of this infection will be calculated.

    36 months

  • Number of participants with angiostrongylosis A. costaricensis

    The crude incidence will be calculated: Reported number of cases of angiostrongylosis A. costaricensis diagnosed during the study inclusion period (3 years) on the total population (population census data). The number of human cases of angiostrongylosis A. costaricensis diagnosed since the emergence of the parasite in the West Indies and Guiana will be calculated. The standardized incidence (on age and sex) of this infection will be calculated.

    36 months

Interventions

Suspected angiostrongylosis - Angiostrongylus cantonensis: * An aliquot of CSF and an aliquot of serum will be sent to the laboratory of tropical medicine in Switzerland for research of specific antibodies. * A CSF aliquot will be sent to the CDC for PCR. Suspected angiostrongylosis- Angiostrongylus costaricensis: \- An aliquot of serum will be sent to the laboratory of tropical medicine in Switzerland for research of specific antibodies.

BiopsyPROCEDURE

Suspected angiostrongylosis - Angiostrongylus costaricensis: \- A piece of biopsy or intestinal resection will be sent to the pathology laboratory for parasitic elements suggestive of Angiostrongylus costaricensis infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All hospitalized patients, whatever their age, sex, weight, presenting hypereosinophilia. Suspicious cases may come from different hospital services (pediatrics, infectiology, resuscitation, neurology, emergencies, ...).

You may qualify if:

  • Hypereosinophilia associated with a meningeal table (= suspicion of neuromeningeal angiostrongylosis), or,
  • Hypereosinophilia associated with a severe gastrointestinal table(= suspicion of intestinal angiostrongylosis)

You may not qualify if:

  • Refusal of the patient to be included in the study
  • Angiostrongylosis of importation (contracted outside the French West Indies - French Guiana region)
  • Absence of hypereosinophilia
  • Hypereosinophilia in the context of an other parasitosis
  • Non-parasitic hypereosinophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Martinique

Fort-de-France, 97261, France

RECRUITING

MeSH Terms

Conditions

Strongylida InfectionsEosinophiliaMeningoencephalitisAngiostrongyliasis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Secernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesCentral Nervous System Viral DiseasesCentral Nervous System InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesMeningitis

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nicole DESBOIS, MD

    CHU of Martinique

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline DARD, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 20, 2017

Study Start

April 3, 2018

Primary Completion

April 3, 2021

Study Completion

August 1, 2021

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations