Immune Response After Leptospirosis Infection

NCT02898519 | Unknown

• 1 other identifier: 2015/CHU/07
• Study Type: observational
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Leptospirosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• rate of still-immunized patients

  1-7 years after leptospirosis infection

• comparison of 3 diagnosis method for leptospirosis

  1-7 years after leptospirosis infection

Interventions

cohort OTHER

Blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Leptospirosis-cured subjects that have undergone leptospirosis

You may qualify if:

• Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015
• with social security issue

You may not qualify if:

• Leptospirosis diagnosis not confirmed by polymerase chain reaction
• subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders)
• under medication: corticoids, immunosuppressor, chemiotherapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead
• Institut Pasteur: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Leptospirosis

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• NICOLAS TRAVERSIER, MD

  CHU DE LA REUNION

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTINE JUHEL, PHD

CONTACT

+262262359949; christine.juhel@chu-reunion.fr

Study Design

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

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share