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Cohort of Hospitalized Patients Suspected of Leptospirosis (COLEPT)

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ClinicalTrials.gov Identifier: NCT04034550
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leptospirosis Other: Blood and urine sampling and blood banking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cohort of Hospitalized Patients Suspected of Leptospirosis
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. disease severity [ Time Frame: 0 to 21 days after onset of symptoms ]
    Rate of death or severe organ insuffisiency



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034550


Contacts
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Contact: Olivier MAILLARD, PharmD, MPH +262262359492 olivier.maillard@chu-reunion.fr

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Loïc RAFFRAY, MD, PhD CHU Reunion, INSERM, CNRS, IRD UMR PIMIT

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04034550     History of Changes
Other Study ID Numbers: C17-47
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
leptospirosis
hospitalization
Additional relevant MeSH terms:
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Leptospirosis
Weil Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections