- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04034550
Cohort of Hospitalized Patients Suspected of Leptospirosis (COLEPT)
May 17, 2022 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olivier MAILLARD, PharmD, MPH
- Phone Number: +262262359492
- Email: olivier.maillard@chu-reunion.fr
Study Locations
-
-
Reunion
-
Saint Benoît, Reunion, France, 97470
- Not yet recruiting
- Groupe Hospitalier Est Réunion (GHER)
-
Contact:
- Stéphanie Dr FAYEULLE
- Phone Number: 0262988202
- Email: s.fayeulle@gher.fr
-
Saint Pierre, Reunion, France, 97410
- Recruiting
- CHU de La Réunion site Sud (GHSR)
-
Contact:
- Yatrika Dr KOUMAR
- Phone Number: 0262359165
- Email: yatrika.koumar@chu-reunion.fr
-
Saint-Denis, Reunion, France, 97400
- Recruiting
- CHU de La Réunion site Nord
-
Contact:
- Loic Dr RAFFRAY
- Phone Number: 0262905450
- Email: loic.raffray@chu-reunion.fr
-
Saint-Paul, Reunion, France, 97460
- Not yet recruiting
- Centre Hospitalier Ouest Réunion (CHOR)
-
Contact:
- Claire FRANCOIS WATTRELOT
- Phone Number: 0262742121
- Email: cl.francois@chor.reunion.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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))
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
In routine management, blood and urine will be sampled for each patients and specific analyses carried out.
Only blood samples will be banked.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease severity
Time Frame: 0 to 21 days after onset of symptoms
|
Rate of death or severe organ insuffisiency
|
0 to 21 days after onset of symptoms
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Loïc RAFFRAY, MD, PhD, CHU Reunion, INSERM, CNRS, IRD UMR PIMIT
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 6, 2021
Primary Completion (ANTICIPATED)
January 6, 2027
Study Completion (ANTICIPATED)
July 1, 2027
Study Registration Dates
First Submitted
July 25, 2019
First Submitted That Met QC Criteria
July 25, 2019
First Posted (ACTUAL)
July 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C17-47
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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