Chronic Post-leptospirosis Manifestations in Reunion (LEPTONIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Leptospirosis
• Intervention / Treatment: Other: Biological sampling and collection

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loic RAFFRAY, Dr; Phone Number: +262 262 90 50 50; Email: loic.raffray@chu-reunion.fr

Study Locations

• France
  • Saint-Paul, France
    • Recruiting
    • CHOR
    • Contact: Claire FRANCOIS, Dr; Phone Number: +262 262 45 30 30
    • Principal Investigator: Claire FRANCOIS, Dr
  • Saint-Pierre, France, 97410
    • Recruiting
    • DIALLO
    • Contact: Kevin DIALLO; Phone Number: 02.62.35.91.65; Email: kevin.diallo@chu-reunion.fr
• Réunion
  • Saint-Benoît, Réunion, 97470
    • Recruiting
    • GHER
    • Sub-Investigator: Stéphanie FAYEULLE, PH
    • Contact: Stéphanie FAYEULLE, dr
  • Saint-Denis, Réunion, 97400
    • Recruiting
    • CHU de la Réunion
    • Principal Investigator: Loic RAFFRAY, MD, PhD
    • Contact: Loic RAFFRAY; Phone Number: +262 0262350000; Email: LOIC.RAFFRAY@chu-reunion.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with chronic post-leptospirosis symptom(s) persisting 2 years after infection.	two years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Estimated): July 24, 2024
• Study Completion (Estimated): July 24, 2026

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spirochaetales Infections; Leptospirosis; Weil Disease
• Other Study ID Numbers: 2022/CHU/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No