French West Indies Leptospirosis Study (LEPTO)

• ClinicalTrials.gov Identifier: NCT01607047
• Recruitment Status: Unknown
• First Posted: May 28, 2012
• Last Update Posted: March 20, 2018
• Sponsor: University Hospital Center of Martinique
• Collaborators: Clinique Antilles-Guyane; Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): University Hospital Center of Martinique

Study Description

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.

Condition or disease
Leptospirosis

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

whole blood, serum, white cells, plasma, DNA

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adults with a leptospirosis diagnosis confirmed by qPCR

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

Contacts and Locations

Locations

France

CHU Pointe-à-Pitre Abymes

Pointe-à-Pitre, Guadeloupe, France, 972

CHU Martinique

Fort De France, Martinique, France, 97261

Sponsors and Collaborators

University Hospital Center of Martinique

Clinique Antilles-Guyane

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

• Principal Investigator: Patrick Hochedez, MD; CHU fort de france

More Information

• Responsible Party: University Hospital Center of Martinique
• ClinicalTrials.gov Identifier: NCT01607047
• Other Study ID Numbers: CHU FDF 10/B/13
• First Posted: May 28, 2012
• Last Update Posted: March 20, 2018
• Last Verified: March 2018

Keywords provided by University Hospital Center of Martinique:

leptospirosis; qPCR; cohort; french west indies; blood sample collection; pronostic; diagnosis

Additional relevant MeSH terms:

Leptospirosis; Weil Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Spirochaetales Infections