Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia (NCT04882046) | Clinical Trial Compass
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Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia
New Caledonia900 participantsStarted 2021-07-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of JHR during follow-up of patients with leptospirosis at the initiation of antibiotic therapy.