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NCT ID: NCT04707235 Recruiting - Sickle Cell Disease Clinical Trials

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

Start date: August 21, 2020
Phase:
Study type: Observational

As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.

NCT ID: NCT04591613 Recruiting - Covid19 Clinical Trials

Late Clinical Events Associated With COVID-19 Infection

COCO-LATE
Start date: December 31, 2020
Phase: N/A
Study type: Interventional

Several publications document the occurrence of symptoms that persist or occur late. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients. Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.

NCT ID: NCT04490850 Recruiting - Covid19 Clinical Trials

COVID-19 Seroprevalence Study in French Guiana

EPI-COVID-POP
Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

NCT ID: NCT04476979 Recruiting - Clinical trials for Coronavirus Infection

Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

TOCIDEX
Start date: July 16, 2020
Phase: Phase 2
Study type: Interventional

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients

NCT ID: NCT04328129 Recruiting - SARS-CoV Infection Clinical Trials

Household Transmission Investigation Study for COVID-19 in Tropical Regions

EPI-COVID-19
Start date: March 23, 2020
Phase: N/A
Study type: Interventional

This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in tropical regions such as French Guiana, Guadeloupe and New-Caledonia.

NCT ID: NCT04322279 Recruiting - Coronavirus Clinical Trials

Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID19.

Start date: March 9, 2020
Phase:
Study type: Observational

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection. In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers. The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition. This include both children and adult subjects, subject without social security, and healthcare workers.

NCT ID: NCT04259892 Recruiting - Coronavirus Clinical Trials

Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection. COVID-19.

Cov-CONTACT
Start date: February 4, 2020
Phase:
Study type: Observational

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

NCT ID: NCT04211649 Not yet 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: April 1, 2020
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 Not yet 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: March 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: NCT03427190 Completed - Suicide Attempt Clinical Trials

Suicide Prevention Algorithm in the French Overseas Territories

APSOM
Start date: October 9, 2017
Phase: N/A
Study type: Interventional

In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.