LeptospirosisSERO7LEPTONCT02898519
Immune Response After Leptospirosis Infection
An observational study of Leptospirosis, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira) growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major public health issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptospirosis
- What is being tested?
- cohort
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2018
- Phase
- Observational
- 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
Study population: Leptospirosis-cured subjects that have undergone leptospirosis
Who may be able to join
- Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015
- with social security issue
Who cannot join
- Leptospirosis diagnosis not confirmed by polymerase chain reaction
- subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders)
- under medication: corticoids, immunosuppressor, chemiotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier
Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira) growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major public health issue.
An important inter-individual variability in humoral immune response suggests that vaccination should be recommended in exposed subjects.
This cohort study aimed to determine if subjects that have been infected by leptospirosis for 1 to 7 years still remain immunized, and then do not need vaccination.
Read the detailed description
Every year more than 500 000 severe forms of leptospirosis are diagnosed in Reunion Island. The risk of mucocutaneous contact with contaminated media remains important due to highly aqueous environment.
Cured subjects that have been infected for 1, 2, 3, 4, 5, 6 or 7 years will be enrolled. The qualitative and quantitative humoral immune response to leptospirosis infection will also be evaluated to determine whether they still get protective immunization. Leptospirosis immunization will be evaluated using micro-agglutination test.
Graded immune responses related to the severity and the length of the infection will also be investigated.
Finally, 3 methods used for leptospirosis diagnosis will be compared. It is expected from this study to evaluate the appropriate conditions in which new vaccination could be required to prevent further leptospirosis infection in cured subjects.
- Conditions
- Leptospirosis
- Being tested
- cohort
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cohortOther
Blood sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptospirosis immunization assessed by serum immunoglobulin
Humoral immune response will be measured in serum cured-subjects using micro-agglutination test
Measured: 1-7 years after leptospirosis infection
Secondary outcomes (2)
rate of still-immunized patients
Seropositive subjects will be measured using the ELISA serion method and the ELISA recombinant protein method
Measured: 1-7 years after leptospirosis infection
comparison of 3 diagnosis method for leptospirosis
Matched results of the 3 methods: micro-agglutination test, ELISA serion method and ELISA recombinant protein method will be compared
Measured: 1-7 years after leptospirosis infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionSep 2018 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- NICOLAS TRAVERSIER, MD, Principal investigator, CHU DE LA REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898519
- Sponsor's protocol ID
- 2015/CHU/07
- Acronym
- SERO7LEPTO
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier
- ClinicalTrials.gov ID
- NCT02898519
- Acronym / sponsor ID
- SERO7LEPTO / 2015/CHU/07
- Conditions
- Leptospirosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Institut Pasteur
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira) growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major public health issue.
An important inter-individual variability in humoral immune response suggests that vaccination should be recommended in exposed subjects.
This cohort study aimed to determine if subjects that have been infected by leptospirosis for 1 to 7 years still remain immunized, and then do not need vaccination.
Detailed description
Every year more than 500 000 severe forms of leptospirosis are diagnosed in Reunion Island. The risk of mucocutaneous contact with contaminated media remains important due to highly aqueous environment.
Cured subjects that have been infected for 1, 2, 3, 4, 5, 6 or 7 years will be enrolled. The qualitative and quantitative humoral immune response to leptospirosis infection will also be evaluated to determine whether they still get protective immunization. Leptospirosis immunization will be evaluated using micro-agglutination test.
Graded immune responses related to the severity and the length of the infection will also be investigated.
Finally, 3 methods used for leptospirosis diagnosis will be compared. It is expected from this study to evaluate the appropriate conditions in which new vaccination could be required to prevent further leptospirosis infection in cured subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Leptospirosis-cured subjects that have undergone leptospirosis
Key inclusion criteria (2 listed)
- Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015
- with social security issue
Key exclusion criteria (3 listed)
- Leptospirosis diagnosis not confirmed by polymerase chain reaction
- subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders)
- under medication: corticoids, immunosuppressor, chemiotherapy
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 |
|---|---|---|
| cohortBlood sampling | Other | – |
Primary outcome
Leptospirosis immunization assessed by serum immunoglobulin
Time frame: 1-7 years after leptospirosis infection
Humoral immune response will be measured in serum cured-subjects using micro-agglutination test
2 secondary outcomes
rate of still-immunized patients
Time frame: 1-7 years after leptospirosis infection
comparison of 3 diagnosis method for leptospirosis
Time frame: 1-7 years after leptospirosis infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Leptospirosis
Not yet recruitingObservational study
Ex Vivo Study of Leukocyte Responses in the Blood of Patients With Leptospirosis and ex Vivo Testing of a New Host-targeted Therapeutic Strategy to Restore Phagocytosis of Leptospira
Leptospirosis, Jarisch Herxheimer Reaction
Not yet recruitingObservational study
Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
Q Fever, Leptospirosis
Not yet recruitingPhase 4
These Studies That Evaluated the Efficacy of Antibiotics for Leptospirosis Treatment.
Leptospirosis, Chemoprophylaxis
Recruiting
Leptospirosis Care Bundle Study
Leptospirosis
Active, not recruiting
Cohort of Hospitalized Patients Suspected of Leptospirosis
Leptospirosis
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.
NICOLAS TRAVERSIER, MD principal investigator
CHU DE LA REUNION
Questions about this trial
What is this clinical trial studying?
An observational study of Leptospirosis, run by Centre Hospitalier Universitaire de la Réunion.
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 2 inclusion and 3 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 CHRISTINE JUHEL, PHD (+262262359949, christine.juhel@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptospirosis immunization assessed by serum immunoglobulin (time frame: 1-7 years after leptospirosis infection). 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 13 Sep 2016.