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NCT ID: NCT04211649 Recruiting - Mild Leptospirosis Clinical Trials

Comparing Two Antibiotic Therapy Periods (3 Versus 7 Days) in Patients With Mild Leptospirosis and Seen at the Hospital in 5 French Overseas Departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte)

LEPTO3
Start date: September 29, 2023
Phase: Phase 4
Study type: Interventional

Leptospirosis is a globally distributed neglected tropical disease affecting subtropical and tropical areas, such as the Caribbean and the Indian Ocean, with favorable climatic conditions for disease transmission. It shows a strong seasonality, with epidemic potential especially after heavy rainfall. A recent systematic review by Costa et al. (2015) places leptospirosis among the leading zoonotic causes of morbidity and mortality worldwide, with 1.03 million cases and 58,900 deaths each year. Leptospirosis is an important public health problem, particularly within economically vulnerable populations. It is also emerging as a health threat in new settings due to globalization and climate change. Disasters and extreme weather events are recognized to precipitate epidemics. Clinical manifestations are highly polymorphic, ranging from an anicteric, influenza-like form to severe forms with hepato-renal or pulmonary failures which are associated with high mortality. Antibiotic therapy should be prescribed early, as soon as leptospirosis is suspected and preferably within the first 5 days, before leptospira spread to the tissues. In the treatment of mild forms, usual antibiotics are oral amoxicillin or doxycycline for a standard treatment duration of 7 days. In hospitalized cases of leptospirosis, parenteral antibiotic therapy with ceftriaxone is often favored as first-line therapy. The most widely used antibiotics in the French Caribbean and Indian Ocean regions are amoxicillin, doxycyclin and third generation cephalosporins such as ceftriaxone. Research hypothesis: The effects of shorter antibiotic therapy periods for other infectious diseases have been explored by several authors. The efficacy of short ceftriaxone treatment has been highlighted for typhoid fever or meningococcal meningitis. In a retrospective series of 21 cases, the interest of short treatment periods (3-6 days) for mild and severe leptospirosis has also been described. A minimal 3-day therapy period would seem necessary in order to biologically confirm leptospirosis diagnosis and to rule out other community-acquired infections. Our study proposal is the conduct of a non-inferiority trial comparing a shortened antibiotic therapy period of 3 days with the standard treatment period of 7 days in patients with mild leptospirosis and seen at the hospital in 5 French overseas departments (Martinique, Guadeloupe, French Guiana, Reunion, Mayotte). Originality and innovative aspects: To our knowledge, the efficacy of a 3-day antibiotic therapy for mild leptospirosis, as compared to the standard 7 day period, has not yet been explored. In addition, the LEPTO3 study will be among the first clinical trials to focus on the endemic public health problem, which is leptospirosis, at a large geographical level (Caribbean and Indian Ocean regions) and to involve a high level of collaboration between medical and scientific teams of these territories.

NCT ID: NCT04076748 Recruiting - Sickle Cell Crisis Clinical Trials

Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.

DREPSUFINDOL
Start date: July 20, 2021
Phase: Phase 3
Study type: Interventional

The analgesic treatment for vaso-occlusive crisis (VOC) in sickle-cell patients is an emergency. The reference treatment is morphine, which requires a venous way sometimes difficult to obtain in these patients. Sufentanil intranasal has been shown to be effective in traumatology. The objective is to evaluate, in VOC, the efficacy of intranasal sufentanil relayed by morphine IV compared to the usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO) relayed by morphine intravenous (IV).

NCT ID: NCT03806452 Recruiting - Sickle Cell Disease Clinical Trials

SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

SIKAMIC
Start date: May 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this phase IIb, international, multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 6 months of treatment in SCD adult patients.

NCT ID: NCT03795376 Recruiting - HIV Prevention Clinical Trials

Dat'Aids Prevention

Start date: January 1, 2019
Phase:
Study type: Observational

DatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France including overseas, aiming to describe HIV prevention in every aspect including HIV screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure prophylaxis

NCT ID: NCT03367650 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Epidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West Indies

SLA-DOM
Start date: May 13, 2014
Phase: N/A
Study type: Interventional

The diagnosis and the follow-up of the patients reached of SLA is centralized, since a few years, at the the Caribbean Reference center of the rare neurological diseases (CERCA labélisé in 2006) in Martinique and at the Unity of coverage of the neuromuscular Diseases, SLA and the rare neurological diseases (create in 2010) in Guadeloupe. Several phenotypic characteristics seemed to us to take out again data collected during the follow-up of the patients (26 in Guadeloupe, since the creation of the unity) in particular patients' high proportion of exceptionally long evolution (more than 10 years). Besides, we diagnosed several cases (10 cases in Guadeloupe since 2000) of association SLA- Parkinsonien Syndrome. This association, considered as exceptional could establish a particular phenotypic entity which we would like to describe. We are interested also originally geographical of the patients, with the hypothesis that he could exist in the Antilles one or several geographical isolates of the disease allowing to lead a étiologique investigation in search of a possible genetic or environmental cause.

NCT ID: NCT03306251 Recruiting - Clinical trials for Mother to Child Transmission of HIV

National Cohort of Children Born to HIV-positive Mothers

EPF
Start date: June 2005
Phase:
Study type: Observational

The purpose of this study is to provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

NCT ID: NCT02898987 Recruiting - HIV Clinical Trials

Quality of Care in French HIV Infected Patients

Dataids_PEC
Start date: January 2016
Phase:
Study type: Observational

The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order : 1. to provide and develop a surveillance system to describe clinical practice and temporal changes in the clinical course of HIV and HIV-related co-infections and co-morbidities in France. 2. to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities The specific objectives are as follows - To continue surveillance of HIV infection in France to describe temporal changes - To evaluate the efficacy of ART and factors associated with ART efficacy - To monitor the uptake and outcome of HCV therapy

NCT ID: NCT02883725 Recruiting - Esophageal Atresia Clinical Trials

National Register of Oesophageal Atresia

REGATE
Start date: January 2008
Phase:
Study type: Observational

The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...). The current prognosis for this ailment is good. However he persists a mortality (<10%) and significant morbidity, firstly related malformations (heart, kidney, for example), and secondly with particularly difficult anatomical forms (Forms long defect) . The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an estimated ± 2,500 new cases over to 10 years in France. The current project aims to set up a national registry (Metropolitan France and Dom Tom) to measure the prevalence of esophageal atresia among live births, phenotypic characteristics, the circumstances of their diagnosis, and their initial future at short-term during the first year of life, at which time occurs the vast majority of deaths and complications in this disease.

NCT ID: NCT01939080 Recruiting - Clinical trials for Cardiovascular Disease

Variation of Aortic Compliance Related to Exercise Training With or Without Supervised Sessions

ACT
Start date: April 2013
Phase: N/A
Study type: Interventional

Many conditions and cardiovascular diseases (including stroke) are better managed with regular exercise training. The expected effects are partial reversal of adverse effects on heart and blood vessel structure and function, improved glycemic, tension and weight control. Physiologically, the aorta maintains low left ventricular after-load, promotes optimal sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow. Increased aortic stiffness may ultimately contribute to left ventricular dysfunction. Regular exercise training is likely to decrease the pulse wave velocity (a measure of the aortic compliance). Some subjects seem more responsive than others, and they may not expect the same benefit of exercise training. To the best of our knowledge, this has not been explained yet.

NCT ID: NCT01689584 Recruiting - Clinical trials for Genetic Predisposition

COsegregation of VARiants in Panel of Genes

COVAR
Start date: July 2, 2012
Phase: N/A
Study type: Interventional

The aim of the COVAR project is to classify reliably a maximum of VUS of the French database in order to use them for the genetic counseling. The results obtained through this study will have a major impact on clinical management of the patients and their families conducting in some cases to propose a prophylactic surgery.