French West Indies Leptospirosis Study (LEPTO)
|ClinicalTrials.gov Identifier: NCT01607047|
Recruitment Status : Active, not recruiting
First Posted : May 28, 2012
Last Update Posted : March 20, 2018
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.
|Condition or disease|
To determine if leptospiral bacterial load is associated with severe evolution of the disease (organ failure, internal bleeding, death) in French West Indies.
- To identify demographic, clinical, biological, bacteriological, and genetic factors (HLA) associated with severe complications of leptospirosis (organ failure, internal bleeding, death).
- To identify demographic, clinical, biological, bacteriological, and genetic factors (HLA) associated with an altered quality of life after the acute phase of leptospirosis.
- To collect human biological samples to allow studies of the individual susceptibility to the infection (genetic polymorphisms, HLA).
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||August 2018|
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607047
|CHU Pointe-à-Pitre Abymes|
|Pointe-à-Pitre, Guadeloupe, France, 972|
|Fort De France, Martinique, France, 97261|
|Principal Investigator:||Patrick Hochedez, MD||CHU fort de france|