Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01607047
Study type Observational
Source University Hospital Center of Martinique
Contact
Status Active, not recruiting
Phase
Start date December 2010
Completion date August 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02898519 - Immune Response After Leptospirosis Infection N/A
Recruiting NCT05425524 - Leptospirosis Care Bundle Study N/A
Completed NCT03912506 - Severe Leptospirosis in Non-tropical Areas
Recruiting NCT04288674 - Leptospirosis Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Invasive Leptospirosis Disease
Recruiting NCT05300425 - Seroprevalence of Leptospirosis in Val Müstair, Switzerland
Completed NCT01080989 - The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands N/A
Recruiting NCT05436756 - Chronic Post-leptospirosis Manifestations in Reunion N/A
Recruiting NCT04882046 - Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia N/A
Terminated NCT00592566 - Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis Phase 2/Phase 3
Recruiting NCT04034550 - Cohort of Hospitalized Patients Suspected of Leptospirosis N/A
Completed NCT05413720 - Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO N/A
Completed NCT01766830 - Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever) N/A
Recruiting NCT02000635 - Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique
Completed NCT03497572 - Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine