Immune Response After Leptospirosis Infection

Leptospirosis Clinical Trial

— SERO7LEPTO  

Official title:

Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02898519
• Other study ID #: 2015/CHU/07
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 8, 2016
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: CHRISTINE JUHEL, PHD
• Phone: +262262359949
• Email: christine.juhel[@]chu-reunion.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

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.

Description:

Every year more than 500 000 severe forms of leptospirosis are diagnosed in Reunion Island. The risk of mucocutaneous contact with contaminated media remains important due to highly aqueous environment.

Cured subjects that have been infected for 1, 2, 3, 4, 5, 6 or 7 years will be enrolled. The qualitative and quantitative humoral immune response to leptospirosis infection will also be evaluated to determine whether they still get protective immunization. Leptospirosis immunization will be evaluated using micro-agglutination test.

Graded immune responses related to the severity and the length of the infection will also be investigated.

Finally, 3 methods used for leptospirosis diagnosis will be compared. It is expected from this study to evaluate the appropriate conditions in which new vaccination could be required to prevent further leptospirosis infection in cured subjects.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leptospirosis

Intervention

Other:
• cohort
Blood sampling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	Institut Pasteur

Outcome

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