French West Indies Leptospirosis Study (LEPTO)

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Guadeloupe
    • Pointe-à-Pitre, Guadeloupe, France, 972
      • CHU Pointe-à-Pitre Abymes
  • Martinique
    • Fort De France, Martinique, France, 97261
      • CHU Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with a leptospirosis diagnosis confirmed by qPCR

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Clinique Antilles-Guyane
• Investigators: Principal Investigator: Patrick Hochedez, MD, CHU Fort de France

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 25, 2012
• First Posted (Estimate): May 28, 2012

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: diagnosis; cohort; qPCR; leptospirosis; pronostic; french west indies; blood sample collection
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spirochaetales Infections; Leptospirosis; Weil Disease
• Other Study ID Numbers: CHU FDF 10/B/13