Trial record 2 of 5 for:    "Leptospirosis"

French West Indies Leptospirosis Study (LEPTO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Clinique Antilles-Guyane
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01607047
First received: May 24, 2012
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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
Leptospirosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • Complicated forms of leptospirosis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607047

Contacts
Contact: Patrick Hochedez, MD 596 55 23 01 ext 00596 patrick.hochedez@chu-fortdefrance.fr

Locations
France
CHU Pointe-à-Pitre Abymes Recruiting
Pointe-à-Pitre, Guadeloupe, France, 972
Contact: Isabelle Lamaury, MD    5 90 89 15 45 ext 00590      
CHU Martinique Recruiting
Fort de France, Martinique, France, 97261
Contact: Patrick Hochedez, MD    596 55 23 01 ext 00596    patrick.hochedez@chu-fortdefrance.fr   
Principal Investigator: Patrick Hochedez, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier: NCT01607047     History of Changes
Other Study ID Numbers: CHU FDF 10/B/13
Study First Received: May 24, 2012
Last Updated: May 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
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

ClinicalTrials.gov processed this record on August 21, 2014