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

Tracking Information

• First Submitted Date: May 24, 2012
• First Posted Date: May 28, 2012
• Last Update Posted Date: March 20, 2018
• Study Start Date: December 2010
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2012)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2012)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: French West Indies Leptospirosis Study
• Official Title: Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies

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).

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

whole blood, serum, white cells, plasma, DNA

• Sampling Method: Non-Probability Sample
• Study Population: Adults with a leptospirosis diagnosis confirmed by qPCR
• Condition: Leptospirosis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: May 25, 2012): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2018
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01607047
• Other Study ID Numbers: CHU FDF 10/B/13
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital Center of Martinique
• Study Sponsor: University Hospital Center of Martinique

Collaborators

• Clinique Antilles-Guyane
• Institut National de la Santé Et de la Recherche Médicale, France

Investigators

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

• PRS Account: University Hospital Center of Martinique
• Verification Date: March 2018