Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05436756
Other study ID # 2022/CHU/16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 25, 2022
Est. completion date July 24, 2026

Study information

Verified date August 2023
Source Centre Hospitalier Universitaire de la Réunion
Contact Loic RAFFRAY, Dr
Phone +262 262 90 50 50
Email loic.raffray@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 198
Est. completion date July 24, 2026
Est. primary completion date July 24, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biological 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

Locations

Country Name City State
France CHOR Saint-Paul
France DIALLO Saint-Pierre
Réunion GHER Saint-Benoît
Réunion CHU de la Réunion Saint-Denis

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Countries where clinical trial is conducted

France,  Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with chronic post-leptospirosis symptom(s) persisting 2 years after infection. two years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02898519 - Immune Response After Leptospirosis Infection N/A
Recruiting NCT05425524 - Leptospirosis Care Bundle Study N/A
Completed NCT03912506 - Severe Leptospirosis in Non-tropical Areas
Recruiting NCT04288674 - Leptospirosis Registry - LeptoScope
Recruiting NCT05300425 - Seroprevalence of Leptospirosis in Val Müstair, Switzerland
Completed NCT01080989 - The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands N/A
Recruiting NCT04882046 - Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia N/A
Terminated NCT00592566 - Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis Phase 2/Phase 3
Recruiting NCT04034550 - Cohort of Hospitalized Patients Suspected of Leptospirosis N/A
Completed NCT05413720 - Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO N/A
Completed NCT01766830 - Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever) N/A
Recruiting NCT02000635 - Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
Active, not recruiting NCT01607047 - French West Indies Leptospirosis Study
Completed NCT03497572 - Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine