Cohort of Hospitalized Patients Suspected of Leptospirosis

NCT04034550 — Not applicable, Active not recruiting, 200 participants, Institut National de la Santé Et de la Recherche Médicale, France

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Registry	NCT04034550, acronym COLEPT
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	200 (Estimated)
Sponsor	Institut National de la Santé Et de la Recherche Médicale, France (Other gov)
Conditions	Leptospirosis
Interventions	Blood and urine sampling and blood banking (Other)
Dates	start 2021-01-06, primary completion 2026-09-06 (estimated), completion 2026-12-31 (estimated), first posted 2019-07-26, last updated 2026-08-20
Locations	4 sites in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
hospitalized patients diagnosed with leptospirosis	Experimental	Other: Blood and urine sampling and blood banking	hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection

Blood and urine sampling and blood banking (Other): In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.

+Outcome measures

Primary outcomes

disease severity [0 to 21 days after onset of symptoms]: Rate of death or severe organ insuffisiency

+Eligibility

Sex: All, ages: 1 Day to any, accepts healthy volunteers

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))

+Locations (4)

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

+Investigators

Loïc RAFFRAY, MD, PhD, Principal investigator, CHU Reunion, INSERM, CNRS, IRD UMR PIMIT