Clinical trial NCT01607047: French West Indies Leptospirosis Study
Official title: Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leptospirosis
Keywords: leptospirosis
qPCR
cohort
french west indies
blood sample collection
pronostic
diagnosis
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: Clinique Antilles-Guyane
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a leptospirosis diagnosis confirmed by qPCR

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.

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

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).

Eligibility criteria: Inclusion Criteria:

* Adults (more than 18 years)
* Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit).
* Diagnosis of leptospirosis confirmed by qPCR
* Possibility of follow-up throughout the 12-week study period.
* Patient registered in the French medical social security national program
* Acceptance to participate in the study and in follow-up; informed consent of the patient or a legal representative (patients unable to sign the consent form).

Exclusion Criteria:

* Negativity of leptospirosis qPCR based diagnosis
* Children under 18 years old
* No possible follow-up after the first visit
* Refusal to participate in the study
* Patient not registered in the French medical social security national program

Primary outcomes:
measure: Complicated forms of leptospirosis
timeFrame: 12 weeks
Secondary outcomes:
measure: quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: France
facility: CHU Pointe-à-Pitre Abymes
state: Guadeloupe
city: Fort De France
country: France
facility: CHU Martinique
state: Martinique
Study officials:
affiliation: CHU fort de france
name: Patrick Hochedez, MD
role: PRINCIPAL_INVESTIGATOR
References: