Leptospirosis Clinical Trial
— SERO7LEPTOOfficial title:
Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier
Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira)
growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas
aera, and especially in Reunion Island, as compared to metropoly, it is considered as a
major public health issue.
An important inter-individual variability in humoral immune response suggests that
vaccination should be recommended in exposed subjects.
This cohort study aimed to determine if subjects that have been infected by leptospirosis
for 1 to 7 years still remain immunized, and then do not need vaccination.
Status | Not yet recruiting |
Enrollment | 175 |
Est. completion date | September 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015 - with social security issue Exclusion Criteria: - Leptospirosis diagnosis not confirmed by polymerase chain reaction - subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders) - under medication: corticoids, immunosuppressor, chemiotherapy |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de la Réunion | Institut Pasteur |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leptospirosis immunization assessed by serum immunoglobulin | Humoral immune response will be measured in serum cured-subjects using micro-agglutination test | 1-7 years after leptospirosis infection | No |
Secondary | rate of still-immunized patients | Seropositive subjects will be measured using the ELISA serion method and the ELISA recombinant protein method | 1-7 years after leptospirosis infection | No |
Secondary | comparison of 3 diagnosis method for leptospirosis | Matched results of the 3 methods: micro-agglutination test, ELISA serion method and ELISA recombinant protein method will be compared | 1-7 years after leptospirosis infection | No |
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