French West Indies Leptospirosis Study

Leptospirosis Clinical Trial

— LEPTO  

Official title:

Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01607047
• Other study ID #: CHU FDF 10/B/13
• Status: Active, not recruiting
• First received: May 24, 2012
• Last updated: March 19, 2018
• Start date: December 2010
• Est. completion date: August 2018

Study information

• Verified date: March 2018
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2018
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leptospirosis

Locations

Country	Name	City	State
France	CHU Martinique	Fort De France	Martinique
France	CHU Pointe-à-Pitre Abymes	Pointe-à-Pitre	Guadeloupe

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	Clinique Antilles-Guyane, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complicated forms of leptospirosis	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.	12 weeks
Secondary	quality of life	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.	12 weeks