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

NCT04882046 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2022-08-17

No results posted yet for this study

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.

Conditions

  • Leptospirosis
  • Jarisch Herxheimer Reaction

Interventions

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.

Sponsors & Collaborators

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Julie CAGLIERO, PhD · Institut Pasteur de Nouvelle-Calédonie

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • New Caledonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882046 on ClinicalTrials.gov