NCT04882046

Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to estimate the incidence of Jarisch-Herxheimer Reactions (JHR) during antibiotic treatment of human leptospirosis cases in New Caledonia. Participants are patients managed in one of the 5 centres participating in the study, in whom a clinical doctor suspected leptospirosis. The average number of leptospirosis cases in New Caledonia is 89 per year. Given the proportion of positive diagnostic tests (approximately 10%) 900 inclusions are planned for this study. Patients are included at the time of the consultation during which leptospirosis is suspected, before the initiation of their antibiotic therapy and independently of the clinical form they presented. Data (socio-demographic and health) and blood samples will be collected at 3 points in the study: at baseline, three hours and six hours after antibiotic treatment. This study will allow better management of patients with leptospirosis.

Detailed description

The objective of the study is to estimate the incidence of Jarisch-Herxheimer Reactions (JHR) during antibiotic treatment of human leptospirosis cases in New Caledonia. Secondary objectives of the study are to describe the JHR during leptospirosis (describe clinical, haemodynamic and cytokine response parameters), to describe the effects of the progressive introduction of antibiotic (ATB) for the treatment of leptospirosis and to harmonise management practices for patients with leptospirosis in NC. Participants are patients managed in one of the 5 centres participating in the study, in whom a clinical doctor suspected leptospirosis. The average number of leptospirosis cases in New Caledonia (NC) is 89 per year. Given the proportion of positive diagnostic tests (approximately 10%) 900 inclusions are planned for this study. Patients are included at the time of the consultation during which leptospirosis is suspected, before the initiation of their antibiotic therapy and independently of the clinical form they presented. Blood samples will be collected at 3 points in the study: at baseline, three hours and six hours after antibiotic treatment. Data will be collected at 4 points in the study: at baseline, three hours, six hours after antibiotic treatment and one day after treatment introduction (last point by phone call). The data obtained will allow us to describe for the first time, in a prospective study, the JHR associated with leptospirosis in a significant number of patients. The data obtained will also help to describe the impact of a therapeutic strategy on the evolution of the disease, which has not yet been evaluated. This study also aims to help harmonise the management of patients with leptospirosis in NC. This study will allow better management of patients with leptospirosis.

Conditions

• Leptospirosis
• Jarisch Herxheimer Reaction

Interventions

Type	Name	Description
OTHER	Blood collection	Blood samples (8ml) at three times of the study: at baseline, 3 hours and 6 hours after treatment
OTHER	Data collection	collection of socio-demographic, clinical and biological data.

Timeline

• Start date: 2021-07-23
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-05-11
• Last updated: 2022-08-17

Locations

5 sites across 1 country: New Caledonia