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CompletedNCT05436756LEPTONICUpdated Aug 6, 2026

Chronic Post-leptospirosis Manifestations in Reunion

An interventional study of Biological sampling and collection in Leptospirosis, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 4 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Not applicable
Sex
All
01

Study summary

Leptospirosis is a zoonosis caused by spirochetes, pathogenic bacteria of the genus Leptospira. It is transmitted to humans through mucocutaneous lesions by contact with water or soil contaminated by the urine of animal reservoirs (rats, dogs, pigs, cattle, etc.). Exposure to fresh water, contact with water or soil contaminated with animal waste are the main risk factors.

This disease is an important public health problem in humans and animals. The annual global incidence is estimated at nearly one million cases with a mortality of 5 to 10% for all cases combined and up to 50% in the event of multi-organ failure. The number of cases is growing and the disease is probably more widespread because it is underdiagnosed. The incidence could increase further in the coming decades due to climate change and rapid urbanization.

In the Overseas Departments and Regions (DROM), it is an endemic condition and its incidence is 10 to 100 times higher than that of mainland France, mainly for climatic reasons. In Réunion, the disease is notifiable with a number of notified cases ranging from 70 to more than 100 cases per year in recent years. Nearly 90% of confirmed cases were hospitalized and more than a third of patients stayed in intensive care.

Recently, a multicenter cohort of patients hospitalized with leptospirosis in La Réunion (COLEPT) was funded by Inserm to identify the severity factors of the disease in patients hospitalized in one of the 4 hospitals on the island. A community of hospital practitioners active on this theme has been identified and constitutes the core of this project. The main objective of the study, the inclusions of which began in January 2020, is to identify the severity factors of leptospirosis in Reunion. Patient follow-up is planned for up to 1 year with 2 medical visits at 1 month and 1 year and 2 telephone interviews on quality of life.

The disease is generally perceived as a purely acute condition with a rapid ad integrum recovery. Nevertheless, the evolution at a distance has been little evaluated. A few publications report complications and elements of chronicity in the medium/long term (>1 year) which would require monitoring these patients over a longer period. Regarding these potential chronic manifestations, they may be chronic fatigue, uveitis, renal failure, chronic renal carriage with urinary excretion of leptospires, myalgia and muscle weakness, headaches, malaise but also cardiac or neurological manifestations. A Dutch study conducted on subjects with confirmed diagnosis reported 30% of patients with chronic post-leptospirosis symptoms which persisted in 21% of subjects more than 24 months after infection, but very few data are available on the chronic forms.

The objective will be to study the future of patients beyond 1 year of infection in clinical and serological terms, but also in terms of quality of life, use of alternative medicines and complementary and health literacy profiles.

02

Conditions studied

  • Leptospirosis

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03

In context

Leptospirosis

25 studies on the registry are indexed under Leptospirosis; 11 are open to participants now.

This study's enrollment of 198 is below the median of 260 across 14 interventional studies indexed under Leptospirosis.

Browse Leptospirosis studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult or child subjects having been included in the COLEPT cohort with confirmed leptospirosis Where
  • Adult subjects or children hospitalized for leptospirosis confirmed within 12-18 months before LEPTONIC inclusion;
  • Be resident in Reunion
  • Ability to answer a telephone questionnaire
  • Benefit from a social security scheme

Exclusion criteria

Exclusion Criteria:

  • Refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.).
  • Exclusion or premature termination of participation in the COLEPT cohort
  • Patient under judicial safeguard, guardianship or curatorship, under activated future protection mandate and family authorization
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
198 participants (actual)

Study arms

  • Other
    sampling and clinical data collection

    * Biological sampling and collection: * whole blood: 1 dry tube for IgG and IgM anti-leptospirosis serology (volume depending on the patient's weight) * urine: 1 bottle of 30ml * Freezing of serum after centrifugation * Storage at Biological Ressources Center * Collection of clinico-biological data on a dedicated eCRF

    Other: Biological sampling and collection

Interventions

  • OtherBiological sampling and collection

    * Biological sampling and collection: * whole blood: 1 dry tube for IgG and IgM anti-leptospirosis serology (volume depending on the patient's weight) * urine: 1 bottle of 30ml * Freezing of serum after centrifugation * Storage * Collection of clinico-biological data on a dedicated eCRF

06

What researchers measure

Primary outcomes

  1. Proportion of patients with chronic post-leptospirosis symptom(s) persisting 2 years after infection.

    Time frame: two years

07

Study locations

4 sites
  • CHOR
    Saint-Paul, France
  • DIALLO
    Saint-Pierre, 97410, France
  • GHER
    Saint-Benoît, 97470, Reunion
  • CHU de la Réunion
    Saint-Denis, 97400, Reunion
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Apr 2026, 45 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2022
First posted
Jun 29, 2022
StartActual
Jul 25, 2022
Primary completionActual
Apr 28, 2026
CompletionActual
Apr 28, 2026
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05436756
Responsible party
Sponsor
First posted
Jun 29, 2022
Start date
Jul 25, 2022
Primary completion
Apr 28, 2026
Completion
Apr 28, 2026
Last update
Aug 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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