COLEPT: Cohort of Hospitalized Patients Suspected of Leptospirosis

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04034550
• Collaborator: (none)
• Enrollment: 200
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 77.8
• Patients Per Site: 50
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Cohort of Hospitalized Patients Suspected of Leptospirosis
• Actual Study Start Date: Jan 6, 2021
• Anticipated Primary Completion Date: Jan 6, 2027
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. disease severity [0 to 21 days after onset of symptoms]

   Rate of death or severe organ insuffisiency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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))

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Est Réunion (GHER)	Saint Benoît	Reunion	France	97470
2	CHU de La Réunion site Sud (GHSR)	Saint Pierre	Reunion	France	97410
3	CHU de La Réunion site Nord	Saint-Denis	Reunion	France	97400
4	Centre Hospitalier Ouest Réunion (CHOR)	Saint-Paul	Reunion	France	97460

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT04034550
• Other Study ID Numbers: C17-47
• First Posted: Jul 26, 2019
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• 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: Leptospirosis; Weil Disease

Study Results

No Results Posted as of May 18, 2022