LeptospirosisLEPJARNCNCT04882046
Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia
A study testing Blood collection and Data collection in people with Leptospirosis and Jarisch Herxheimer Reaction, run by Institut Pasteur at 5 sites in New Caledonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptospirosis, Jarisch Herxheimer Reaction
- What is being tested?
- Blood collection and Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 5 sitesNew Caledonia
- Study dates
- 23 Jul 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
New Caledonia5 sites, 5 recruiting
- Not yet recruiting
Centre Médico-Social Jeanne Boutin
Bourail, Nouvelle Calédonie
Leo Vincent, Dr
- Not yet recruiting
Centre hospitalier du Nord
Kone
Olivier Kesteman, Dr
- Recruiting
Centre hospitalier du Nord
Koumac
Patrick Lefevre, Dr
- Not yet recruiting
Centre hospitalier Territorial Gaston-Bourret
Noumea, Nouvelle Calédonie
Cecile CAZORLA, Dr
- Not yet recruiting
Centre hospitalier du Nord
Poindimié
Francois Baur, Dr
About this study
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.
Read more
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.
Read the 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 study are to describe the JHR during leptospirosis (describe clinical, haemodynamic and cytokine response parameters), to describe the effects of the progressive introduction of antibiotic (ATB) for the treatment of leptospirosis and to harmonise management practices for patients with leptospirosis in NC.
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 (NC) 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.
Blood samples will be collected at 3 points in the study: at baseline, three hours and six hours after antibiotic treatment.
Data will be collected at 4 points in the study: at baseline, three hours, six hours after antibiotic treatment and one day after treatment introduction (last point by phone call).
The data obtained will allow us to describe for the first time, in a prospective study, the JHR associated with leptospirosis in a significant number of patients.
The data obtained will also help to describe the impact of a therapeutic strategy on the evolution of the disease, which has not yet been evaluated. This study also aims to help harmonise the management of patients with leptospirosis in NC.
This study will allow better management of patients with leptospirosis.
- Conditions
- Leptospirosis, Jarisch Herxheimer Reaction
- Being tested
- Blood collection, Data collection
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood samples (8ml) at three times of the study: at baseline, 3 hours and 6 hours after treatment
Data collectionOther
collection of socio-demographic, clinical and biological data.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed by a clinician who suspects leptospirosis | Other | Not described Receives: Other: Blood collection; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
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.
Measured: 1 year
Description of inflammatory markers during JHR
Description of markers of inflammation (inflammatory cytokines as TNF-α (tumor necrosis factors alpha), IL-1β, IL-10, IL-8, IL-6 (interleukines) and CRP) on patients with leptospirosis
Measured: 1 year
Association of markers of inflammation with the onset of JHR.
Association of markers of inflammation (inflammatory cytokines as TNF-α, IL-1β, IL-10, IL-8, IL-6 and CRP) with the apparition of JHR on patients with leptospirosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start23 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie CAGLIERO, PhD, Study director, Institut Pasteur de Nouvelle-Calédonie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882046
- Sponsor's protocol ID
- 2020-072
- Acronym
- LEPJARNC
- Status last verified
- Aug 2022
- First submitted
- 28 Apr 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia
- ClinicalTrials.gov ID
- NCT04882046
- Acronym / sponsor ID
- LEPJARNC / 2020-072
- Conditions
- Leptospirosis, Jarisch Herxheimer Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 study are to describe the JHR during leptospirosis (describe clinical, haemodynamic and cytokine response parameters), to describe the effects of the progressive introduction of antibiotic (ATB) for the treatment of leptospirosis and to harmonise management practices for patients with leptospirosis in NC.
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 (NC) 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.
Blood samples will be collected at 3 points in the study: at baseline, three hours and six hours after antibiotic treatment.
Data will be collected at 4 points in the study: at baseline, three hours, six hours after antibiotic treatment and one day after treatment introduction (last point by phone call).
The data obtained will allow us to describe for the first time, in a prospective study, the JHR associated with leptospirosis in a significant number of patients.
The data obtained will also help to describe the impact of a therapeutic strategy on the evolution of the disease, which has not yet been evaluated. This study also aims to help harmonise the management of patients with leptospirosis in NC.
This study will allow better management of patients with leptospirosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed by a clinician who suspects leptospirosis | Other | Other: Blood collection, Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Under 18 years of age
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionBlood samples (8ml) at three times of the study: at baseline, 3 hours and 6 hours after treatment | Other | patients diagnosed by a clinician who suspects leptospirosis |
| Data collectioncollection of socio-demographic, clinical and biological data. | Other | patients diagnosed by a clinician who suspects leptospirosis |
Primary outcome
Incidence of JHR during follow-up of patients with leptospirosis at the initiation of antibiotic therapy.
Time frame: 1 year
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).
4 secondary outcomes
Description of JHR during leptospirosis
Time frame: 1 year
Description of the administration of antibiotic treatment used for leptospirosis.
Time frame: 1 year
Description of inflammatory markers during JHR
Time frame: 1 year
Association of markers of inflammation with the onset of JHR.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie CAGLIERO, PhD study director
Institut Pasteur de Nouvelle-Calédonie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection and Data collection in people with Leptospirosis and Jarisch Herxheimer Reaction, run by Institut Pasteur at 5 sites in New Caledonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in New Caledonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie CAGLIERO, PhD (+687 93 71 37, jcagliero@pasteur.nc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of JHR during follow-up of patients with leptospirosis at the initiation of antibiotic therapy. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.