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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 March 2022
Main ID:  NCT02000635
Date of registration: 20/11/2013
Prospective Registration: Yes
Primary sponsor: University Hospital Center of Martinique
Public title: Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique Ciné LEPTO
Scientific title: Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
Date of first enrolment: December 2014
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02000635
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Martinique
Contacts
Name:     Janick JEAN-MARIE, Master
Address: 
Telephone: 0596592697
Email: janick.jean-marie@chu-fortdefrance.fr
Affiliation: 
Name:     Janick JEAN-MARIE, Master
Address: 
Telephone: 0596592697
Email: janick.jean-marie@chu-fortdefrance.fr
Affiliation: 
Name:     Patrick Hochedez, MD
Address: 
Telephone:
Email:
Affiliation:  CHU de Fort de France
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Leptospirosis
Intervention(s)
Other: Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day
Primary Outcome(s)
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]
Secondary Outcome(s)
Secondary ID(s)
2013-A01128-37
13/B/16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Clinique Antilles-Guyane
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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