French West Indies Leptospirosis Study (LEPTO)
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ClinicalTrials.gov Identifier: NCT01607047 |
Recruitment Status : Unknown
Verified March 2018 by University Hospital Center of Martinique.
Recruitment status was: Active, not recruiting
First Posted : May 28, 2012
Last Update Posted : March 20, 2018
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Tracking Information | ||||
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First Submitted Date | May 24, 2012 | |||
First Posted Date | May 28, 2012 | |||
Last Update Posted Date | March 20, 2018 | |||
Study Start Date | December 2010 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Complicated forms of leptospirosis [ Time Frame: 12 weeks ] Occurrence, during follow-up (for 12 weeks following symptom onset), of shock, internal bleeding, failure of one or several organs or systems (brain, heart, lung, liver, kidney, clotting system), or death.
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
quality of life [ Time Frame: 12 weeks ] Changes in quality of life, measured with the EuroQol® questionnaire in the first 3 weeks and 12 weeks after the onset of dengue fever symptoms.
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | French West Indies Leptospirosis Study | |||
Official Title | Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies | |||
Brief Summary | Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the tropics, where conditions for transmissions are favorable. The disease is endemic in Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains and contaminate the environment by shedding the organisms in their urine. Humans are usually infected through abraded skin or mucous membrane contact with water contaminated by the urine of animal reservoirs, and less frequently by direct contact with animals or their urine. The mean incubation period is 10 days, with a usual range of 2-20 days. Clinical manifestations are protean and the spectrum of symptoms range from subclinical or mild anicteric febrile illness to acute renal failure and respiratory distress syndrome which are associated with high mortality rates. The microscopic agglutination test (MAT) and culture are the reference standard test for diagnosis of leptospirosis, but they are only available in reference laboratories and their conclusive results requires convalescent sample or prolonged incubation. At present, only direct detection methods using PCR might provide rapid diagnosis during the early acute stage of the illness, when treatment is likely to have the greatest benefit. Quantitative PCR also offers the ability to measure level of leptospiremia in clinical samples. Using qPCR based diagnosis, the investigators have the opportunity to study the association of level of leptospiremia and clinical manifestations in French West Indies. All qPCR-positive samples will be used for molecular typing. |
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Detailed Description | Principal objective To determine if leptospiral bacterial load is associated with severe evolution of the disease (organ failure, internal bleeding, death) in French West Indies. Secondary objective
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: whole blood, serum, white cells, plasma, DNA
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Sampling Method | Non-Probability Sample | |||
Study Population | Adults with a leptospirosis diagnosis confirmed by qPCR | |||
Condition | Leptospirosis | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Actual Enrollment |
150 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | August 2018 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 120 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01607047 | |||
Other Study ID Numbers | CHU FDF 10/B/13 | |||
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 |
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Investigators |
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PRS Account | University Hospital Center of Martinique | |||
Verification Date | March 2018 |