Cohort of Hospitalized Patients Suspected of Leptospirosis

Leptospirosis Clinical Trial

— COLEPT  

Official title:

Cohort of Hospitalized Patients Suspected of Leptospirosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034550
• Other study ID #: C17-47
• Status: Recruiting
• Phase: N/A
• 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
• 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))

Related Conditions & MeSH terms

• Leptospirosis

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