Cohort of Hospitalized Patients Suspected of Leptospirosis

NCT04034550 | Active Not Recruiting DMC

• 1 other identifier: C17-47
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Leptospirosis

Keywords

leptospirosis; hospitalization

Outcome Measures

Primary Outcomes (1)

• disease severity

  Rate of death or severe organ insuffisiency

  0 to 21 days after onset of symptoms

Study Arms (1)

hospitalized patients diagnosed with leptospirosis

EXPERIMENTAL

hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection

Other: Blood and urine sampling and blood banking

Interventions

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.

hospitalized patients diagnosed with leptospirosis

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (4)

Groupe Hospitalier Est Réunion (GHER)

Saint-Benoît, Reunion, 97470, France

Location

CHU de La Réunion site Nord

Saint-Denis, Reunion, 97400, France

Location

Centre Hospitalier Ouest Réunion (CHOR)

Saint-Paul, Reunion, 97460, France

Location

CHU de La Réunion site Sud (GHSR)

Saint-Pierre, Reunion, 97410, France

Location

MeSH Terms

Conditions

Leptospirosis

Interventions

Blood Specimen Collection; Blood Banking

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Blood Preservation; Tissue Preservation; Preservation, Biological; Therapeutics; Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Loïc RAFFRAY, MD, PhD

  CHU Reunion, INSERM, CNRS, IRD UMR PIMIT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 26, 2019
• Study Start: January 6, 2021
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (4)