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Virus Diseases clinical trials

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NCT ID: NCT06155266 Recruiting - Clinical trials for Bacterial and Viral Infections

Combination of Leukocyte Cell Surface Biomarkers Measured by Cytometry, to Differentiate Bacterial From Viral Infections in Emergency Department: a Multicentric Cohort for the Validation of Diagnostic Performances

CYTOBACT
Start date: May 14, 2024
Phase:
Study type: Observational

The characterization of the bacterial or viral etiology of an infectious event is required for both isolation decisions and rationale use of antibiotics. In emergency room (ER), the direct identification of the causal pathogen is rarely available in real-time. Alternative is the identification of the host-response to either a bacterial or viral infection. One of this host-response is the expression of peripheral leukocytes cell surface markers, measured by flow cytometry. Investigators and others have reported the high diagnostic performances of combination of cell surface biomarkers to differentiate bacterial from viral infection. The CYTOBACT study aims to confirm on a 500 patients multicentric cohort (200 having already been collected during another study: SEPTIMET), the best combinations for this diagnostic issue. The study will be conducted in 3 emergency departments of APHP hospitals network in Paris, France. Patients with a suspicion of infection will be proposed to participate. No intervention will be introduced during the routine care in the (ER) which will be let at the discretion of the treating emergency physician. During the routine blood sampling in the ER, an additional 30 ml volume of whole blood will be collected, centrifugated, aliquoted and stored at -80°C for further measurement of the expression of a panel of cell surface markers. The participants will be followed up during their hospitalization (if any) and no longer than 28 days. Clinical data at admission, usual blood tests and all microbiological investigations performed during the hospital stay will be recorded into an electronic case record form (eCRF). Based on all those recorded data (excepted the results of flow cytometry for cell surface biomarkers) 2 independent adjudicators will qualify the infectious episode into bacterial,viral or no infection, and (if any) into infection, sepsis or septic shock (according to Sepsis 3.0 definitions). Using different "machine learning" statistical tools, all the combination of the cell surface biomarkers will be tested to select those with the highest performance to differentiate bacterial from viral infection.

NCT ID: NCT06149494 Recruiting - Copd Clinical Trials

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection

Start date: November 20, 2023
Phase: Phase 2
Study type: Interventional

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.

NCT ID: NCT06143046 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

NCT ID: NCT06126822 Not yet recruiting - Ebola Virus Disease Clinical Trials

Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination With the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC

EBO-BOOST
Start date: March 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules. Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.

NCT ID: NCT06123936 Recruiting - Clinical trials for Influenza Viral Infections

Impact on Influenza Vaccination Rates of a Telephone Text Message Recall From the Attending Physician

GP-FluRecall
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

This study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their GP. Twenty-two GPs will be randomly selected in each arm (recall versus usual care, 1:1). Each GP will include a maximum of 210 patients by random selection from their patient list. A difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate.

NCT ID: NCT06113757 Recruiting - COVID-19 Clinical Trials

Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease

DoBiC-19
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Dr. Biolyse® is a device with artificial intelligence that works in sync with the immune system and can be integrated like an element of this system. It is designed to develop chemical immunity within the body against infections. It gives electrical signals to the body without causing any pain and suffering to the patient. The electric current it applies is of a type that is not used in homes, and it is the frequency feature of direct current. The aim of this study is to evaluate the safety and efficacy of the Biolyse device. for minimizing the use of drugs in COVID-19 patients and treating drug-related organ damage during treatment We hope that by conducting this study, we will obtain sufficient data to obtain approval (CE certification) for routine use and marketing of this medical device in patients. Once this happens, we will be able to ensure that this device is accessible/usable for patients suffering from similar diseases, especially COVID-19, regardless of any studies.

NCT ID: NCT06100913 Not yet recruiting - Ebola Virus Disease Clinical Trials

Immunology of Ebola Vaccine

Start date: July 2024
Phase: Phase 2
Study type: Interventional

In this study 30 healthy adult participants will receive a single dose of an Ebola vaccine. Blood samples, fine needle aspirates, core biopsies, and bone marrow aspirates will be collected prior to and following vaccination to assess immune responses in the blood, lymph nodes, and bone marrow over multiple time points.

NCT ID: NCT06099873 Not yet recruiting - Clinical trials for Respiratory Viral Infection

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents

ZX-7101A-207
Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents. The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents.

NCT ID: NCT06097299 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus

Start date: October 24, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years of age and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of age to inform the dose level selection for the next phase of development (Phase 3).

NCT ID: NCT06096571 Not yet recruiting - Clinical trials for Viral Infection COVID-19

Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

1. Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers, based on AE/SAE (adverse events/serious adverse event) analysis; 2. Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers. 3. To conclude on the bioequivalence of Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in healthy volunteers.