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Trial record 64 of 256 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique (Ciné LEPTO)

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ClinicalTrials.gov Identifier: NCT02000635
Recruitment Status : Recruiting
First Posted : December 4, 2013
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Clinique Antilles-Guyane
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief 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). 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.


Condition or disease Intervention/treatment
Leptospirosis Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
Study Start Date : December 2014
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Leptospirosis
Patient with a diagnosis of leptospirosis confirmed by PCR in the five first day
Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of leptospirosis confirmed
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000635


Contacts
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Contact: Janick JEAN-MARIE, Master 0596592697 ext +596 janick.jean-marie@chu-fortdefrance.fr

Locations
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Martinique
Chu de Martinique Recruiting
Fort de France, Martinique, 97200
Contact: Janick JEAN-MARIE, Master    0596592697 ext +596    janick.jean-marie@chu-fortdefrance.fr   
Principal Investigator: Patrick Hochedez, MD         
Sponsors and Collaborators
University Hospital Center of Martinique
Clinique Antilles-Guyane
Investigators
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Principal Investigator: Patrick Hochedez, MD CHU de Fort de France

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT02000635     History of Changes
Other Study ID Numbers: 13/B/16
2013-A01128-37 ( Registry Identifier: ID RCB )
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Leptospirosis
Weil Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Anti-Bacterial Agents
Anti-Infective Agents