Leptospirosis Clinical Trial
Official title:
Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies
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.
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
1. To identify demographic, clinical, biological, bacteriological, and genetic factors
(HLA) associated with severe complications of leptospirosis (organ failure, internal
bleeding, death).
2. To identify demographic, clinical, biological, bacteriological, and genetic factors
(HLA) associated with an altered quality of life after the acute phase of leptospirosis.
3. To collect human biological samples to allow studies of the individual susceptibility to
the infection (genetic polymorphisms, HLA).
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