Leptospirosis Clinical Trial
— LEPJARNCOfficial title:
Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia
NCT number | NCT04882046 |
Other study ID # | 2020-072 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 23, 2021 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | December 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
New Caledonia | Centre Médico-Social Jeanne Boutin | Bourail | Nouvelle Calédonie |
New Caledonia | Centre hospitalier du Nord | Koné | |
New Caledonia | Centre hospitalier du Nord | Koumac | |
New Caledonia | Centre hospitalier Territorial Gaston-Bourret | Nouméa | Nouvelle Calédonie |
New Caledonia | Centre hospitalier du Nord | Poindimié |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur |
New Caledonia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Description of JHR during leptospirosis | The description of the groups of patient with JHR will be compared to the group without JHR in terms of clinical and haemodynamic parameters Any occurrence of other unexpected clinical symptoms will be described. | 1 year | |
Secondary | Description of the administration of antibiotic treatment used for leptospirosis. | The incidence of JHR will be described on a case-by-case basis according to the antibiotic treatment (type of antibiotics, dose and mode of administration) implemented by the clinician. | 1 year | |
Secondary | Description of inflammatory markers during JHR | Description of markers of inflammation (inflammatory cytokines as TNF-a (tumor necrosis factors alpha), IL-1ß, IL-10, IL-8, IL-6 (interleukines) and CRP) on patients with leptospirosis | 1 year | |
Secondary | Association of markers of inflammation with the onset of JHR. | Association of markers of inflammation (inflammatory cytokines as TNF-a, IL-1ß, IL-10, IL-8, IL-6 and CRP) with the apparition of JHR on patients with leptospirosis | 1 year |
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