LeptospirosisCiné LEPTONCT02000635
Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
An observational study of Leptospirosis, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence (0,47/100 000). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptospirosis
- What is being tested?
- Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day
- How many people
- 50 participants
- Where
- 1 siteMartinique
- Study dates
- Dec 2014to Jul 2022
- 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: Patients with a diagnosis of leptospirosis confirmed
Who may be able to join
- Adults ( more than 18 years)
- Diagnosis of leptospirosis confirmed by PCR in the five first day
- Appeal to one of the hospital departments participating in the research: in emergency room, in complete hospitalization
- Affiliated patients or beneficiaries of a national insurance scheme
- Acceptance to participate in the study and in the proposed follow-up, and signature of the consent signed by the person or by his(her) representative
Who cannot join
- Test of negative PCR
- Children under age 18
- No possible follow-up after the first visit
- Pregnant patient
- Refusal of participation in the study
- Unaffiliated patients or beneficiaries of a national insurance scheme.
Trial locations and contacts
1 site in 1 country.
Martinique1 site, 1 recruiting
- Recruiting
Chu de Martinique
Fort-de-France, 97200
Janick JEAN-MARIE, Master, 0596592697 ext. +596, janick.jean-marie@chu-fortdefrance.fr
Patrick Hochedez, MD
About this study
The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are described as meningitis, uveitis and classical severe presentation such as lung bleedings and liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the disease.
Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic confirmation during the first week of development and before the appearance of the first antibody.
Read more
If the microagglutination test (MAT) is considered the gold standard test for diagnosis of leptospirosis. However it requires rending samples to the referent National center for the leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the second week of illness. A second sample is required 15 days after the first one, to confirm the diagnosis.
In clinical practice , the technique of real-time PCR for the detection and quantification of pathogenic Leptospira during the first week of illness . The technique of diagnosis of leptospirosis by real-time PCR has been implemented and tested in 2007 at the University Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days, regardless of the severity of the disease. The evolution of leptospiremia treated patients has not been studied to date.
- Conditions
- Leptospirosis
- Being tested
- Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th dayOther
| Study group | Role | What they receive |
|---|---|---|
| Leptospirosis | Patient with a diagnosis of leptospirosis confirmed by PCR in the five first day Receives: Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of concentration of leptospires in the blood during the first 7 days after the recruitment.
For each patient, 5-6 quantitative PCR will be performed during the treatment at : The inclusion , 24 hours after the recruitment, 48 hours , 72 hours and the 7th day after the recruitment . In case of positive result of the quantitative PCR at the 7th day of treatment, late charge will be made around the 14th day.
Measured: At the recruitment, 24 hours, 48 hours 72 hours and the 7th day after the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2014
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Antilles-Guyane
- Responsible party
- Sponsor
- Investigators
- Patrick Hochedez, MD, Principal investigator, CHU de Fort de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000635
- Sponsor's protocol ID
- 13/B/16
- Other IDs
- 2013-A01128-37
- Acronym
- Ciné LEPTO
- Status last verified
- Mar 2022
- First submitted
- 20 Nov 2013
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
- ClinicalTrials.gov ID
- NCT02000635
- Acronym / sponsor ID
- Ciné LEPTO / 13/B/16
- Conditions
- Leptospirosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Clinique Antilles-Guyane
- Study start
- Dec 2014
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 4 Dec 2013 (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.
The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are described as meningitis, uveitis and classical severe presentation such as lung bleedings and liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the disease.
Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic confirmation during the first week of development and before the appearance of the first antibody.
If the microagglutination test (MAT) is considered the gold standard test for diagnosis of leptospirosis. However it requires rending samples to the referent National center for the leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the second week of illness. A second sample is required 15 days after the first one, to confirm the diagnosis.
In clinical practice , the technique of real-time PCR for the detection and quantification of pathogenic Leptospira during the first week of illness . The technique of diagnosis of leptospirosis by real-time PCR has been implemented and tested in 2007 at the University Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days, regardless of the severity of the disease. The evolution of leptospiremia treated patients has not been studied to date.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leptospirosis | – | Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th dayPatient with a diagnosis of leptospirosis confirmed by PCR in the five first day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of leptospirosis confirmed
Key inclusion criteria (5 listed)
- Adults ( more than 18 years)
- Diagnosis of leptospirosis confirmed by PCR in the five first day
- Appeal to one of the hospital departments participating in the research: in emergency room, in complete hospitalization
- Affiliated patients or beneficiaries of a national insurance scheme
- Acceptance to participate in the study and in the proposed follow-up, and signature of the consent signed by the person or by his(her) representative
Key exclusion criteria (6 listed)
- Test of negative PCR
- Children under age 18
- No possible follow-up after the first visit
- Pregnant patient
- Refusal of participation in the study
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 |
|---|---|---|
| Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day | Other | Leptospirosis |
Primary outcome
Change of concentration of leptospires in the blood during the first 7 days after the recruitment.
Time frame: At the recruitment, 24 hours, 48 hours 72 hours and the 7th day after the recruitment
For each patient, 5-6 quantitative PCR will be performed during the treatment at : The inclusion , 24 hours after the recruitment, 48 hours , 72 hours and the 7th day after the recruitment . In case of positive result of the quantitative PCR at the 7th day of treatment, late charge will be made around the 14th day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
Patrick Hochedez, MD principal investigator
CHU de Fort de France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptospirosis, run by University Hospital Center of Martinique at 1 site in Martinique.
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 5 inclusion and 6 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. 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 Janick JEAN-MARIE, Master (0596592697 ext. +596, janick.jean-marie@chu-fortdefrance.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of concentration of leptospires in the blood during the first 7 days after the recruitment. (time frame: At the recruitment, 24 hours, 48 hours 72 hours and the 7th day after the recruitment). 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 9 Mar 2022.