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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

Tracking Information
First Submitted Date November 20, 2013
First Posted Date December 4, 2013
Last Update Posted Date March 20, 2018
Study Start Date December 2014
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02000635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
Official Title Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Patients with a diagnosis of leptospirosis confirmed
Condition Leptospirosis
Intervention Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day
Study Groups/Cohorts Leptospirosis
Patient with a diagnosis of leptospirosis confirmed by PCR in the five first day
Intervention: Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 27, 2013)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Janick JEAN-MARIE, Master 0596592697 ext +596 janick.jean-marie@chu-fortdefrance.fr
Listed Location Countries Martinique
Removed Location Countries  
 
Administrative Information
NCT Number NCT02000635
Other Study ID Numbers 13/B/16
2013-A01128-37 ( Registry Identifier: ID RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital Center of Martinique
Study Sponsor University Hospital Center of Martinique
Collaborators Clinique Antilles-Guyane
Investigators
Principal Investigator: Patrick Hochedez, MD CHU de Fort de France
PRS Account University Hospital Center of Martinique
Verification Date March 2018