French West Indies Leptospirosis Study

NCT01607047 | Unknown

• 1 other identifier: CHU FDF 10/B/13
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Leptospirosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• quality of life

  12 weeks

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a leptospirosis diagnosis confirmed by qPCR

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Clinique Antilles-Guyane: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

CHU Pointe-à-Pitre Abymes

Pointe à Pitre, Guadeloupe, 972, France

Location

CHU Martinique

Fort de France, Martinique, 97261, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, plasma, DNA

MeSH Terms

Conditions

Leptospirosis; Disease

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Hochedez, MD

  CHU fort de france

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: December 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: August 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

FR (2)