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

NCT04882046 | Unknown

• 1 other identifier: 2020-072
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 5

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 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

Outcome Measures

Primary Outcomes (1)

• Incidence of JHR during follow-up of patients with leptospirosis at the initiation of antibiotic therapy.

  The incidence of JHR will be calculated on the total number of patients included by recording the number of participants who developed or showed an aggravation of at least one of the following clinical symptoms: Fever, tremor, chills, headache, muscle stiffness and/or pain and change in the patient's haemodynamic status (blood pressure, pulse, respiratory rate, oxygen saturation).

  1 year

Secondary Outcomes (4)

• Description of JHR during leptospirosis

  1 year

• Description of the administration of antibiotic treatment used for leptospirosis.

  1 year

• Description of inflammatory markers during JHR

  1 year

• Association of markers of inflammation with the onset of JHR.

  1 year

Study Arms (1)

patients diagnosed by a clinician who suspects leptospirosis

OTHER

Other: Blood collection; Other: Data collection

Interventions

Blood collection OTHER

Blood samples (8ml) at three times of the study: at baseline, 3 hours and 6 hours after treatment

patients diagnosed by a clinician who suspects leptospirosis

Data collection OTHER

collection of socio-demographic, clinical and biological data.

patients diagnosed by a clinician who suspects leptospirosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be suspected of developing leptospirosis by the clinician in one of the 5 participating centres
• Have expressed their oral consent to participate in this research project
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (5)

Centre Médico-Social Jeanne Boutin

Bourail, Nouvelle Calédonie, New Caledonia

NOT YET RECRUITING

Centre hospitalier Territorial Gaston-Bourret

Noumea, Nouvelle Calédonie, New Caledonia

NOT YET RECRUITING

Centre hospitalier du Nord

Koné, New Caledonia

NOT YET RECRUITING

Centre hospitalier du Nord

Koumac, New Caledonia

RECRUITING

Centre hospitalier du Nord

Poindimié, New Caledonia

NOT YET RECRUITING

MeSH Terms

Conditions

Leptospirosis

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julie CAGLIERO, PhD

  Institut Pasteur de Nouvelle-Calédonie

  STUDY DIRECTOR

Central Study Contacts

Julie CAGLIERO, PhD

CONTACT

+687 93 71 37; jcagliero@pasteur.nc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 11, 2021
• Study Start: July 23, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

NE (5)