Actively Recruiting

Phase Not Applicable
All Genders
ID05436756

Chronic Post-leptospirosis Manifestations in Reunion

Led by Centre Hospitalier Universitaire de la Réunion · Updated on 2023-08-31

198

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Leptospirosis is a bacterial infection transmitted to humans through contact with water or soil contaminated by animal urine, posing a significant public health concern. This research focuses on patients in Reunion, where leptospirosis is more common due to climate factors. The study aims to identify factors linked to the severity of leptospirosis and investigate long-term effects, including symptoms persisting beyond one year after infection. The study involves biological sampling including blood and urine collection for serology tests, freezing and storage of serum samples, and collecting clinical and biological data. Patients previously hospitalized with confirmed leptospirosis within 12 to 18 months are followed up. Two medical visits and two telephone interviews will assess quality of life and other health aspects over a year, with plans to monitor outcomes up to two years. Participants will have blood and urine samples collected and will be asked to complete telephone questionnaires. The study measures the proportion of patients experiencing chronic symptoms two years after infection, tracking clinical, serological, and quality of life outcomes. Data collection occurs through dedicated electronic forms, with participant follow-up lasting up to two years to better understand chronic manifestations of leptospirosis.

CONDITIONS

Brief Title

Chronic Post-leptospirosis Manifestations in Reunion

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult or child subjects having been included in the COLEPT cohort with confirmed leptospirosis
  • Hospitalized for leptospirosis confirmed within 12-18 months before inclusion
  • Resident of Reunion
  • Ability to answer a telephone questionnaire
  • Covered by a social security scheme
Not Eligible

You will not qualify if you...

  • Refusal to participate by patient or representative if patient cannot give opinion
  • Exclusion or early termination from the COLEPT cohort
  • Under judicial safeguard, guardianship, curatorship, or family authorization under protection mandate

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Sampling and Clinical Data Collection

Duration - Single visit

Participants provide biological samples including whole blood and urine for serology and other analyses, and clinical data are collected.

1 visit (in-person)

Trial Site Locations

Total: 4 locations

1

CHOR

Saint-Paul, France

Actively Recruiting

2

DIALLO

Saint-Pierre, France, 97410

Actively Recruiting

3

GHER

Saint-Benoît, Reunion, 97470

Actively Recruiting

4

CHU de la Réunion

Saint-Denis, Reunion, 97400

Actively Recruiting

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Research Team

L

Loic RAFFRAY, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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