AngiostrongylosisACCRAGNCT03378882
Research for Angiostrongylus Cantonensis and Costaricensis in French West Indies and French Guiana
An observational study of Angiostrongylosis and Hypereosinophilia, run by University Hospital Center of Martinique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angiostrongylosis, Hypereosinophilia
- What is being tested?
- Parasitic serologies and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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, ...).
Who may be able to join
- Hypereosinophilia associated with a meningeal table (= suspicion of neuromeningeal angiostrongylosis), or,
- Hypereosinophilia associated with a severe gastrointestinal table(= suspicion of intestinal angiostrongylosis)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Céline DARD, MD contact
France1 site, 1 recruiting
- Recruiting
CHU of Martinique
Fort-de-France, 97261
Nicole DESBOIS, MD
About this study
Official title: Research for Angiostrongylus Cantonensis and Costaricensis in French West Indies and French Guiana: a Clinical and Environmental Study
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.
Read more
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.
Read the detailed description
Angiostrongylosis is a parasitosis caused by the nematode Angiostrongylus sp. The adult parasite lives in the rat's arteries (Rattus norvegicus and Rattus rattus), its definitive host, where it breeds. Stage 1 immature larvae are released into the environment in rat droppings. Stage 3 larval maturation, which is essential for the re-contamination of final hosts, is mainly carried out in the Buyina fulica mollusc (common name: Achatine).
The mode of contamination in humans is by ingestion of stage 3 parasitic larvae according to various modes: accidental ingestion of molluscs or salads soiled by "molluscan slime" (example: by consumption of salad, vegetables, non-washed fruits), voluntary ingestion of molluscs, manipulation of molluscs (children or fishermen), use of drinking water drawn from natural and non-disinfected water bodies. Hand-carried transmission after handling of Achatines is most often reported in young children.
In humans, these larvae have a different preferential tropism depending on the species of Angiostrongylus. The two main pathogenic species for humans are Angiostrongylus cantonensis and Angiostrongylus costaricensis.
Angiostrongylus cantonensis:
After ingestion by man, the larvae of Angiostrongylus cantonensis migrate to the central nervous system. They cause eosinophilic angiostrongyl meningitis and meningoencephalitis, which can lead to severe neurological sequelae (paralysis) or even death.
These clinical features are associated with eosinophilic pleocytosis in CSF (eosinophilic meningitis) and blood eosinophilia.
Angiostrongylus cantonensis was first described in Canton, China in 1935. To date, it is present in the Pacific Islands, Australia, Africa and recently on the American continent.
Angiostrongylus costaricensis:
After ingestion, the larvae of Angiostrongylus costaricensis migrate intestines and into the abdominal cavity. They cause severe abdominal pain mimicking those of appendicitis, haemorrhage and perforation digestive that can lead to death (2 to 8% of cases).
A major eosinophilia usually accompanies these unspecific clinical pictures. Angiostrongylus costaricensis does not have the same geographical distribution as Angiostrongylus cantonensis. It was first described in Costa Rica in 1967 and is endemic on the American continent, where it is at the origin of many human cases.
- Conditions
- Angiostrongylosis, Hypereosinophilia
- Being tested
- Parasitic serologies, Biopsy
- Keywords
- Angiostrongylosis, Hypereosinophilia, Eosinophilic meningitis, Meningoencephalitis, Achatina fulica, Angiostrongylus cantonensis, Angiostrongylus costaricensis
- Medical subject headings
- Strongylida Infections, Eosinophilia, Meningoencephalitis, Angiostrongyliasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasitic serologiesBiological
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 or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start3 Apr 2018
- Primary completion3 Apr 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiostrongylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center of Pointe-à-Pitre/Abymes (Guadeloupe), Hospital Center of Basse-Terre (Guadeloupe), Hospital Center of Cayenne (French Guiana), Hospital Center of Saint-Laurent du Maroni (French Guiana)
- Responsible party
- Sponsor
- Investigators
- Nicole DESBOIS, MD, Principal investigator, CHU of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378882
- Sponsor's protocol ID
- 17/E/05
- Acronym
- ACCRAG
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Angiostrongylus Cantonensis and Costaricensis in French West Indies and French Guiana: a Clinical and Environmental Study
- ClinicalTrials.gov ID
- NCT03378882
- Acronym / sponsor ID
- ACCRAG / 17/E/05
- Conditions
- Angiostrongylosis, Hypereosinophilia
- Keywords
- Angiostrongylosis, Hypereosinophilia, Eosinophilic meningitis, Meningoencephalitis, Achatina fulica, Angiostrongylus cantonensis, Angiostrongylus costaricensis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- University Hospital Center of Pointe-à-Pitre/Abymes (Guadeloupe), Hospital Center of Basse-Terre (Guadeloupe), Hospital Center of Cayenne (French Guiana), Hospital Center of Saint-Laurent du Maroni (French Guiana)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 3 Apr 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Angiostrongylosis is a parasitosis caused by the nematode Angiostrongylus sp. The adult parasite lives in the rat's arteries (Rattus norvegicus and Rattus rattus), its definitive host, where it breeds. Stage 1 immature larvae are released into the environment in rat droppings. Stage 3 larval maturation, which is essential for the re-contamination of final hosts, is mainly carried out in the Buyina fulica mollusc (common name: Achatine).
The mode of contamination in humans is by ingestion of stage 3 parasitic larvae according to various modes: accidental ingestion of molluscs or salads soiled by "molluscan slime" (example: by consumption of salad, vegetables, non-washed fruits), voluntary ingestion of molluscs, manipulation of molluscs (children or fishermen), use of drinking water drawn from natural and non-disinfected water bodies. Hand-carried transmission after handling of Achatines is most often reported in young children.
In humans, these larvae have a different preferential tropism depending on the species of Angiostrongylus. The two main pathogenic species for humans are Angiostrongylus cantonensis and Angiostrongylus costaricensis.
Angiostrongylus cantonensis:
After ingestion by man, the larvae of Angiostrongylus cantonensis migrate to the central nervous system. They cause eosinophilic angiostrongyl meningitis and meningoencephalitis, which can lead to severe neurological sequelae (paralysis) or even death.
These clinical features are associated with eosinophilic pleocytosis in CSF (eosinophilic meningitis) and blood eosinophilia.
Angiostrongylus cantonensis was first described in Canton, China in 1935. To date, it is present in the Pacific Islands, Australia, Africa and recently on the American continent.
Angiostrongylus costaricensis:
After ingestion, the larvae of Angiostrongylus costaricensis migrate intestines and into the abdominal cavity. They cause severe abdominal pain mimicking those of appendicitis, haemorrhage and perforation digestive that can lead to death (2 to 8% of cases).
A major eosinophilia usually accompanies these unspecific clinical pictures. Angiostrongylus costaricensis does not have the same geographical distribution as Angiostrongylus cantonensis. It was first described in Costa Rica in 1967 and is endemic on the American continent, where it is at the origin of many human cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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, ...).
Key inclusion criteria (2 listed)
- Hypereosinophilia associated with a meningeal table (= suspicion of neuromeningeal angiostrongylosis), or,
- Hypereosinophilia associated with a severe gastrointestinal table(= suspicion of intestinal angiostrongylosis)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasitic serologiesSuspected 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. | Biological | – |
| BiopsySuspected 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 | Procedure or surgery | – |
Primary outcome
Number of participants with angiostrongylosis A. cantonensis
Time frame: 36 months
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.
Number of participants with angiostrongylosis A. costaricensis
Time frame: 36 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline DARD, MD contact
Nicole DESBOIS, MD principal investigator
CHU of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angiostrongylosis and Hypereosinophilia, run by University Hospital Center of Martinique at 1 site in France.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Dec 2020. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole DESBOIS, MD (0596559665 ext. +33, nicole.desbois-nogard@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with angiostrongylosis A. cantonensis (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2020.