Cohort of Hospitalized Patients Suspected of Leptospirosis (COLEPT)

July 29, 2024 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Reunion
      • Saint Benoît, Reunion, France, 97470
        • Groupe Hospitalier Est Réunion (GHER)
      • Saint Pierre, Reunion, France, 97410
        • CHU de La Réunion site Sud (GHSR)
      • Saint-Denis, Reunion, France, 97400
        • CHU de La Réunion site nord
      • Saint-Paul, Reunion, France, 97460
        • Centre Hospitalier Ouest Réunion (CHOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hospitalized patients diagnosed with leptospirosis
hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease severity
Time Frame: 0 to 21 days after onset of symptoms
Rate of death or severe organ insuffisiency
0 to 21 days after onset of symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Loïc RAFFRAY, MD, PhD, CHU Reunion, INSERM, CNRS, IRD UMR PIMIT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Estimated)

January 6, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C17-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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