Status:

UNKNOWN

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

Lead Sponsor:

Institut Pasteur

Conditions:

Leptospirosis

Jarisch Herxheimer Reaction

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 mana...

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 st...

Eligibility Criteria

Inclusion

  • Be over 18 years of age (at the time of inclusion);
  • Be suspected of developing leptospirosis by the clinician in one of the 5 participating centres
  • Have been informed of the use of their samples for non-therapeutic scientific research purposes by a note and information sheet established by the Institut Pasteur of New Caledonia (IPNC) and the Institut Pasteur Paris (IPP), provided and explained by the inclusion centre.
  • Have expressed their oral consent to participate in this research project
  • Non inclusion criteria:
  • Under 18 years of age
  • Have not given oral consent to participate
  • Have a chronic inflammatory disease.
  • Having concomitant antibiotic and/or anti-inflammatory treatment or medical management incompatible with the purpose of the study,
  • Pregnant or breastfeeding women.

Exclusion

  • \- Leptospirosis diagnostic is not confirmed by molecular biology. Complete destruction of the corresponding samples will be ensured. Clinical data and biological analyses will also be removed from the data associated with the research.

Key Trial Info

Start Date :

July 23 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

900 Patients enrolled

Trial Details

Trial ID

NCT04882046

Start Date

July 23 2021

End Date

December 1 2023

Last Update

August 17 2022

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Centre Médico-Social Jeanne Boutin

Bourail, Nouvelle Calédonie, New Caledonia

2

Centre hospitalier Territorial Gaston-Bourret

Noumea, Nouvelle Calédonie, New Caledonia

3

Centre hospitalier du Nord

Koné, New Caledonia

4

Centre hospitalier du Nord

Koumac, New Caledonia

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