LeptospirosisCOLEPTNCT04034550
Cohort of Hospitalized Patients Suspected of Leptospirosis
A study testing Blood and urine sampling and blood banking in people with Leptospirosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Leptospirosis
- What is being tested?
- Blood and urine sampling and blood banking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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))
Trial locations and contacts
4 sites in 1 country.
France4 sites
Groupe Hospitalier Est Réunion (GHER)
Saint-Benoît, Reunion, 97470
CHU de La Réunion site Nord
Saint-Denis, Reunion, 97400
Centre Hospitalier Ouest Réunion (CHOR)
Saint-Paul, Reunion, 97460
CHU de La Réunion site Sud (GHSR)
Saint-Pierre, Reunion, 97410
About this study
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
- Being tested
- Blood and urine sampling and blood banking
- Keywords
- leptospirosis, hospitalization
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine sampling and blood bankingOther
In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.
| Study group | Role | What they receive |
|---|---|---|
| hospitalized patients diagnosed with leptospirosis | Experimental | hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection Receives: Other: Blood and urine sampling and blood banking |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease severity
Rate of death or severe organ insuffisiency
Measured: 0 to 21 days after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start6 Jan 2021
- Primary completion6 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Loïc RAFFRAY, MD, PhD, Principal investigator, CHU Reunion, INSERM, CNRS, IRD UMR PIMIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034550
- Sponsor's protocol ID
- C17-47
- Acronym
- COLEPT
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Hospitalized Patients Suspected of Leptospirosis
- ClinicalTrials.gov ID
- NCT04034550
- Acronym / sponsor ID
- COLEPT / C17-47
- Conditions
- Leptospirosis
- Keywords
- leptospirosis, hospitalization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 6 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalized patients diagnosed with leptospirosis | Experimental | Other: Blood and urine sampling and blood bankinghospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine sampling and blood bankingIn routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked. | Other | hospitalized patients diagnosed with leptospirosis |
Primary outcome
disease severity
Time frame: 0 to 21 days after onset of symptoms
Rate of death or severe organ insuffisiency
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for Leptospirosis
Not yet recruitingObservational study
Ex Vivo Study of Leukocyte Responses in the Blood of Patients With Leptospirosis and ex Vivo Testing of a New Host-targeted Therapeutic Strategy to Restore Phagocytosis of Leptospira
Leptospirosis, Jarisch Herxheimer Reaction
Not yet recruitingObservational study
Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
Q Fever, Leptospirosis
Not yet recruitingPhase 4
These Studies That Evaluated the Efficacy of Antibiotics for Leptospirosis Treatment.
Leptospirosis, Chemoprophylaxis
Recruiting
Leptospirosis Care Bundle Study
Leptospirosis
RecruitingPhase 2
Preventive Strategies for Early and Late Complications of Leptospirosis
Leptospirosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc RAFFRAY, MD, PhD principal investigator
CHU Reunion, INSERM, CNRS, IRD UMR PIMIT
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and urine sampling and blood banking in people with Leptospirosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease severity (time frame: 0 to 21 days after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.