Trial record 3 of 6 for: "Leptospirosis"

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Immune Response After Leptospirosis Infection (SERO7LEPTO)

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified September 2016 by Centre Hospitalier Universitaire de la Réunion

Sponsor:

Collaborator:

Institut Pasteur

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT02898519

First received: September 8, 2016

Last updated: NA

Last verified: September 2016

History: No changes posted

Purpose

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.

Condition	Intervention
Leptospirosis	Other: cohort


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Leptospirosis

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de la Réunion:

Primary Outcome Measures:

Leptospirosis immunization assessed by serum immunoglobulin [ Time Frame: 1-7 years after leptospirosis infection ]
Humoral immune response will be measured in serum cured-subjects using micro-agglutination test

Secondary Outcome Measures:

rate of still-immunized patients [ Time Frame: 1-7 years after leptospirosis infection ]
Seropositive subjects will be measured using the ELISA serion method and the ELISA recombinant protein method
comparison of 3 diagnosis method for leptospirosis [ Time Frame: 1-7 years after leptospirosis infection ]
Matched results of the 3 methods: micro-agglutination test, ELISA serion method and ELISA recombinant protein method will be compared

Biospecimen Retention: Samples Without DNA

Plasma


Estimated Enrollment:	175
Study Start Date:	October 2016
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Intervention Details:

Blood sampling

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Leptospirosis-cured subjects that have undergone leptospirosis

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02898519

Contacts


Contact: CHRISTINE JUHEL, PHD	+262262359949	christine.juhel@chu-reunion.fr

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Institut Pasteur

Investigators


Principal Investigator:	NICOLAS TRAVERSIER, MD	CHU DE LA REUNION

More Information


Responsible Party:	Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:	NCT02898519 History of Changes
Other Study ID Numbers:	2015/CHU/07
Study First Received:	September 8, 2016
Last Updated:	September 8, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Leptospirosis Weil Disease Gram-Negative Bacterial Infections Bacterial Infections Spirochaetales Infections

ClinicalTrials.gov processed this record on July 14, 2017

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