Study of Decreasing Kinetics of the Leptospiremia During Antibiotic Treatment of Leptospirosis in Martinique

NCT ID: NCT02000635

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2022-07-31

Brief Summary

The leptospirosis evolves on an endemic mode in French West Indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan France's incidence (0,47/100 000). If cases can arise all year long, periods of heavy rainfall are associated with the arisen of epidemic peaks Clinical presentation of leptospirosis include a wide range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are described as meningitis, uveitis and classical severe presentation such as lung bleedings and liver-kidneys infringement (syndrome of Weil) which constitute the most severe forms of the disease.

Currently , Polymerase chain reaction (PCR) is the only test who can provide a diagnostic confirmation during the first week of development and before the appearance of the first antibody.

If the microagglutination test (MAT) is considered the gold standard test for diagnosis of leptospirosis. However it requires rending samples to the referent National center for the leptospirosis at Pasteur Institute in Paris while the antibodies do not appears until the second week of illness. A second sample is required 15 days after the first one, to confirm the diagnosis.

In clinical practice , the technique of real-time PCR for the detection and quantification of pathogenic Leptospira during the first week of illness . The technique of diagnosis of leptospirosis by real-time PCR has been implemented and tested in 2007 at the University Hospital of Martinique and providing to the clinicians from 2008. The optimal duration of antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days, regardless of the severity of the disease. The evolution of leptospiremia treated patients has not been studied to date.

Conditions

Leptospirosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Leptospirosis

Patient with a diagnosis of leptospirosis confirmed by PCR in the five first day

Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day

Intervention Type: OTHER

Interventions

Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults ( more than 18 years)
• Diagnosis of leptospirosis confirmed by PCR in the five first day
• Appeal to one of the hospital departments participating in the research: in emergency room, in complete hospitalization
• Affiliated patients or beneficiaries of a national insurance scheme
• Acceptance to participate in the study and in the proposed follow-up, and signature of the consent signed by the person or by his(her) representative

Exclusion Criteria

• Test of negative PCR
• Children under age 18
• No possible follow-up after the first visit
• Pregnant patient
• Refusal of participation in the study
• Unaffiliated patients or beneficiaries of a national insurance scheme.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Antilles-Guyane

OTHER

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Hochedez, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Fort de France

Locations

Chu de Martinique

Fort-de-France, , Martinique

Site Status: RECRUITING

Countries

Martinique

Central Contacts

Janick JEAN-MARIE, Master

Role: CONTACT

janick.jean-marie@chu-fortdefrance.fr

0596592697 ext. +596

Facility Contacts

Janick JEAN-MARIE, Master

Role: primary

janick.jean-marie@chu-fortdefrance.fr

0596592697 ext. +596

Other Identifiers

2013-A01128-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

13/B/16

Identifier Type: -

Identifier Source: org_study_id