Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02000635
Other study ID # 13/B/16
Secondary ID 2013-A01128-37
Status Recruiting
Phase
First received
Last updated
Start date December 2014
Est. completion date July 2022

Study information

Verified date March 2022
Source University Hospital Center of Martinique
Contact Janick JEAN-MARIE, Master
Phone 0596592697
Email janick.jean-marie@chu-fortdefrance.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Martinique Chu de Martinique Fort de France

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Center of Martinique Clinique Antilles-Guyane

Country where clinical trial is conducted

Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of concentration of leptospires in the blood during the first 7 days after the recruitment. For each patient, 5-6 quantitative PCR will be performed during the treatment at : The inclusion , 24 hours after the recruitment, 48 hours , 72 hours and the 7th day after the recruitment . In case of positive result of the quantitative PCR at the 7th day of treatment, late charge will be made around the 14th day. At the recruitment, 24 hours, 48 hours 72 hours and the 7th day after the recruitment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02898519 - Immune Response After Leptospirosis Infection N/A
Recruiting NCT05425524 - Leptospirosis Care Bundle Study N/A
Completed NCT03912506 - Severe Leptospirosis in Non-tropical Areas
Recruiting NCT04288674 - Leptospirosis Registry - LeptoScope
Recruiting NCT05300425 - Seroprevalence of Leptospirosis in Val Müstair, Switzerland
Completed NCT01080989 - The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands N/A
Recruiting NCT05436756 - Chronic Post-leptospirosis Manifestations in Reunion N/A
Recruiting NCT04882046 - Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia N/A
Terminated NCT00592566 - Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis Phase 2/Phase 3
Recruiting NCT04034550 - Cohort of Hospitalized Patients Suspected of Leptospirosis N/A
Completed NCT05413720 - Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO N/A
Completed NCT01766830 - Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever) N/A
Active, not recruiting NCT01607047 - French West Indies Leptospirosis Study
Completed NCT03497572 - Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine