Cohort of Hospitalized Patients Suspected of Leptospirosis

NCT ID: NCT04034550

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2027-07-31

Brief Summary

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COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.

Detailed Description

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Conditions

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Leptospirosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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hospitalized patients diagnosed with leptospirosis

hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection

Group Type EXPERIMENTAL

Blood and urine sampling and blood banking

Intervention Type OTHER

In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.

Interventions

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Blood and urine sampling and blood banking

In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* clinico-biological manifestations compatible with acute leptospirosis OR proven leptospirosis with serological testing or PCR
* onset of symptoms within 21 days
* participant benefits of health insurance

Exclusion Criteria

* participant's refusal, or refusal from his relatives in case of major incapacity of the eligible participant precluding expression of his will (coma, stay in intensive care unit))
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Loïc RAFFRAY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Reunion, INSERM, CNRS, IRD UMR PIMIT

Locations

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Groupe Hospitalier Est Réunion (GHER)

Saint-Benoît, Reunion, France

Site Status

CHU de La Réunion site Nord

Saint-Denis, Reunion, France

Site Status

Centre Hospitalier Ouest Réunion (CHOR)

Saint-Paul, Reunion, France

Site Status

CHU de La Réunion site Sud (GHSR)

Saint-Pierre, Reunion, France

Site Status

Countries

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France

Other Identifiers

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C17-47

Identifier Type: -

Identifier Source: org_study_id

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