Cohort of Hospitalized Patients Suspected of Leptospirosis | NCT04034550

Studies
Cohort of Hospitalized Patients Suspected of Leptospirosis

NCT04034550

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Status

Active, not recruiting

Last Update Posted

Jul 30, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Leptospirosis

Interventions

Blood and urine sampling and blood banking

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2021Actual

Primary Completion Date

Jan 6, 2027Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Jul 25, 2019

First Submission Date that Met QC Criteria

Jul 25, 2019

First Posted Date

Jul 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Jul 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease severity	Rate of death or severe organ insuffisiency	0 to 21 days after onset of symptoms

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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))

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Loïc RAFFRAY, MD, PhD	CHU Reunion, INSERM, CNRS, IRD UMR PIMIT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Est Réunion (GHER)		Saint-Benoît	Reunion	97470	France
CHU de La Réunion site Nord

Condition Browse Module

MeSH Terms

ID	Term
D007922	Leptospirosis

Ancestor Terms

ID	Term
D013145	Spirochaetales Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D000094902	Blood Banking

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided