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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04034550
Other study ID # C17-47
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 6, 2021
Est. completion date July 2027

Study information

Verified date May 2022
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Olivier MAILLARD, PharmD, MPH
Phone +262262359492
Email olivier.maillard@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 2027
Est. primary completion date January 6, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Groupe Hospitalier Est Réunion (GHER) Saint Benoît Reunion
France CHU de La Réunion site Sud (GHSR) Saint Pierre Reunion
France CHU de La Réunion site Nord Saint-Denis Reunion
France Centre Hospitalier Ouest Réunion (CHOR) Saint-Paul Reunion

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease severity Rate of death or severe organ insuffisiency 0 to 21 days after onset of symptoms
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