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Infectious Disease clinical trials

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NCT ID: NCT06159270 Recruiting - Infectious Disease Clinical Trials

Infectious Prospective Collection for Biological Analysis

Infectieux1
Start date: May 18, 2019
Phase:
Study type: Observational

The increase in activity within medical biology laboratories linked to the arrival of new markers (in cardiology, oncology, infectious diseases, etc.) and the acceleration of technical progress have created a prominent place for automated systems and their reagent kits within these establishments. It is in this context that CerbaXpert took the initiative to set up this research project for the collection of prospective biological samples and their analysis. It transcribes both a process of continuous improvement but also scientific development, making it possible to provide new and/or complementary data in order to improve the operation of automated systems and their reagents within medical biology laboratories. These data obtained in current practice via this study will also be compared with the technical information provided by the manufacturers of the reagents and their automatic devices.

NCT ID: NCT06024421 Recruiting - Infectious Disease Clinical Trials

Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers

FAVIDOSE
Start date: April 2024
Phase: Phase 1
Study type: Interventional

FAVIDOSE trial is a Phase I randomized, double blind controlled, monocentric, dose escalation clinical trial. The primary purpose of this trial is to evaluate tolerance of high doses of favipiravir for 14 days in healthy volunteers. This trial also looks to characterize favipiravir pharmacokinetics in blood and favipiravir levels in sperm. A pharmacogenetics analysis will be conducted in an attempt to identify genetic variants of metabolism and transport enzymes of favipiravir to explain the inter-individual variability of pharmacokinetic parameters of favipiravir. Three sequential dose levels including distinctive participants: - level 1: D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning; - level 2: D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning; - level 3: D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning. Three study groups of maximum of 8 participants, 6 receiving favipiravir and 2 receiving placebo per dose level, three dose levels proposed. Seven additional participants with the same follow up will be included and randomized (6:1 ratio) at the maximum tolerated dose level to allow a satisfactory accurate characterization of pharmacokinetics and pharmacogenetics of favipiravir and their determinants (maximum 39 participants in total, taking into account 8 participants - 2 per dose level - replaced because loss of follow-up before the end of treatment).

NCT ID: NCT06004739 Recruiting - Infectious Disease Clinical Trials

Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection

A-DONUT
Start date: April 2024
Phase: N/A
Study type: Interventional

Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.

NCT ID: NCT05780099 Recruiting - Clinical trials for Cardiovascular Diseases

Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

MED-Cli
Start date: June 24, 2022
Phase:
Study type: Observational

Patients referred to internal medicine wards are becoming increasingly complex and fragile. Despite deep knowledge of their specific disorders, steps are required to improve overall management of their acute and chronic conditions. The main objective of the study is to identify demographic, clinical, laboratory and radiological markers of disease severity and activity in patients with diseases treated at general medicine wards (respiratory disease, immune-mediated disease, sepsis, metabolic disease, rare disease, frailty, pregnancy pathology) in order to improve their diagnosis, monitoring and treatment processes.

NCT ID: NCT05743335 Recruiting - COVID-19 Clinical Trials

A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine

Start date: March 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about, test, and compare JCXH-221 in healthy volunteers. The main aims to answer are: - To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects - To identify an optimal dose for the JCXH-221 vaccine in healthy adult subjects - To assess the humoral immunogenicity of the JCXH-221 vaccine in healthy adult subjects - To characterize the cellular immunogenicity of the JCXH-221 vaccine in healthy adult subjects Participants for Phase I will be randomized to either JCXH-221 or placebo. In Phase 2, participants will be randomized to either JCXH-221 or a FDA approved Active comparator.

NCT ID: NCT05568953 Recruiting - Infectious Disease Clinical Trials

An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity

Start date: September 28, 2022
Phase: Phase 2
Study type: Interventional

We hypothesize that a high CD4+ and CD8+ T cell count will reduce viremia upon challenge with a structurally heterologous virus, and correspondingly result in reduced magnitude of host response to challenge infection. Primary Objective: To compare, after challenge with a structurally heterologous vaccine, the differences in levels of viremia between healthy adults who received primary vaccination with either YF17D vaccine, chimeric JE-YF17D vaccine, or inactivated JE vaccine. 58 subjects will be randomised into 1 of 2 arms (Arm B1 and Arm B2) in a 1:1 ratio, in a double-blind fashion. Subjects in Arm B1 will receive JE-YF17D vaccine (Imojev, Sanofi Pasteur) on Day 0 followed by YF17D vaccine (Stamaril, Sanofi Pasteur) on Day 28. Subjects in Arm B2 will receive Stamaril on Day 0 followed by Imojev on Day 28. Arm B3 will be conducted as a separate single-arm open label design in 14 subjects. Subjects in Arm B3 will receive inactivated JE vaccine (Ixiaro, Valneva) on Day 0 followed by Stamaril on Day 28. The rationale for these three study arms is as follows: Arm B1 will show the impact low levels of viremia, and the resultant low levels of virus-specific CD4+ and CD8+ T cells, would have on YF17D infection. In contrast, YF17D vaccination in Arm B2 would produce high levels of viremia, and in turn high levels virus-specific T cells, thus likely ameliorating JE-YF17D infection. Arm B3 will serve as the control arm, as vaccination with inactivated JE vaccine would not produce any YF17D-specific T cell response. Notably, the first vaccination in Arms B1 and B2 would also provide the viremia response in the absence of virus-specific T cells, which would serve as a reference point to interpret the outcome of the second vaccination.

NCT ID: NCT05507086 Recruiting - Infectious Disease Clinical Trials

Infectious Pseudochromdrosis Caused by Bacillus Cereus

Blue sweat
Start date: January 1, 2020
Phase:
Study type: Observational

Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus.

NCT ID: NCT05400824 Recruiting - Clinical trials for Cardiovascular Diseases

Metabolic and Infectious Diseases in La Réunion (the REUNION Population-based Study)

Start date: May 1, 2022
Phase:
Study type: Observational

The aim of the present study is to determine the prevalence of cardiometabolic and infectious disease in La Reunion (french oversea department and region of France). Known or suspected risk factor for these diseases will also be assessed, such as microbiota, cognitive impairement, social inequalities, and genetics.

NCT ID: NCT05388747 Recruiting - Infectious Disease Clinical Trials

Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Start date: May 16, 2022
Phase:
Study type: Observational

Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic,effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.

NCT ID: NCT05350995 Recruiting - Emergencies Clinical Trials

Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

EVAPAUR
Start date: May 13, 2022
Phase:
Study type: Observational

French health insurance data indicate that approximately 15% of ambulatory antibiotic consumption is generated by hospital prescriptions. This extra-hospital consumption represents a greater volume than intra-hospital consumption. To date, hospital indicators of good antibiotic use do not include this outpatient dimension. This study will provide a snapshot of the proportion of ambulatory antibiotics generated by emergencies and analyze compliance with management recommendations.This study will serve as a basis for developing indicators of outpatient antibiotic consumption generated by hospital activity and for identifying specific intervention targets aimed at the misuse situations that have been highlighted. This study will be carried out in the form of a repeated survey on a given day (4 days, one across each season), carried out by the local mobile antibiotic therapy team, using a standardized grid. The survey will concern all the medical records of the patients visiting any emergency department on the days of the survey. The evaluation of antibiotic therapies prescribed in discharge orders will be carried out in accordance with local management recommendations by the site investigator (infectious disease and/or emergency medicine specialist), who will assess whether the prescription is in accordance with the recommendations or not.