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Communicable Diseases clinical trials

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NCT ID: NCT05168709 Completed - COVID-19 Clinical Trials

Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction

COSI BAIR
Start date: January 20, 2022
Phase: Phase 4
Study type: Interventional

The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to investigate the specific and heterologous effects of COVID-19 vaccination on immunity in children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after their final Coronavirus Disease 2019 (COVID-19) vaccination. Venous blood samples will be collected at two study visits, at Murdoch Children's Research Institute (MCRI): 1. Day 0 - baseline (day of COVID-19 vaccination #1), and 2. Day 84 (28 days after COVID-19 vaccination #2).

NCT ID: NCT05166369 Completed - Clinical trials for Acute Respiratory Tract Infections

Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)

OptimAP
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

Background: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We will assess whether remotely delivered complex interventions including internet-based training for health care provider, and an educational intervention for parents could improve prescribing practices for respiratory tract infections (RTI) in Spain. Methods: We will develop and evaluate the feasibility of two interventions in a 16-months randomized controlled factorial trial. Primary care (PC) centres will be allocated to one of the following four groups: 1. Intervention targeting healthcare providers (paediatricians, nurses and pharmacists): i) Internet based training about communication skills and optimal antibiotic prescribing (including delayed prescribing); ii) bimonthly antibiotic prescription feedback. 2. Intervention targeting parents: PC centres allocated to this group will display posters and flyers presenting a mobile app that will include information about respiratory tract infections and optimal use of antibiotics. The app can be used before, during and after the consultation, providing condition specific and patient tailored information. 3. Intervention targeting both providers and parents 4. No intervention. During the trial duration we will conduct a process evaluation and a cost-effectiveness analysis. Our primary outcome will be change in the total antibiotic prescription rate. Our secondary outcomes will include: respiratory complications (e.g. pneumonia), antibiotic related adverse effects, repeated consultations, and antibiotic consumption in relation with antibiotic prescribing (delayed antibiotic prescribing). Assuming an average cluster size of 200 RTI consultations per centre, we will need to recruit 222 PC centres.

NCT ID: NCT05164692 Completed - Clinical trials for Acute Respiratory Tract Infections

Effects of Nasal-spraying LiveSpo Navax in Treatment of Acute Respiratory Infections in Children

Start date: August 29, 2020
Phase: N/A
Study type: Interventional

Rationals: Infection with the Respiratory Syncytial Virus (RSV) is one of the most common causes of respiratory tract diseases. However, treatment for pediatric RSV infection remains supportive to prevent co-infection bacteria and respiratory failure. In recent years, preventive and supportive probiotic therapies for respiratory tract infections (RTIs) have been increasingly strengthened, however, the use of oral administrative probiotics as functional foods is effective only for mild symptoms and not applicable for Acute RTIs (ARTIs). Here, we propose that direct spraying of probiotics into the nose can be a fast and effective symptomatic treatment for ARTIs. Objectives: Investigate symptomatic treatment effects of probiotic product LiveSpo Navax, as liquid-suspension form containing Bacillus spores of safe B. subtilis ANA4 and B. clausii ANA39 strains, in children having acute respiratory diseases caused by RSV: - Primary Objective: Evaluation of improved efficacy and reduced treatment time of LiveSpo Navax in children infected with RSV. - Secondary Objectives: Measurement of changes in RSV viral load, co-infectious bacterial concentrations, and major cytokine indicators in the nasopharyngeal mucosa before and after 3 days using LiveSpo Navax. Endpoints: Primary endpoint: LiveSpo Navax alleviates RSV-infection symptoms about 25% more effectively, as indicated by 90% of patients using LiveSpo Navax (Navax group) are symptom-free at day 3-6 of intervention depending on symptoms, compared to 65% of patients in Control group. Secondary endpoint: Patients in Navax group had more significant reductions in RSV load (>10 fold) than patients in Control group at day 3 of intervention. Study Population: Sample size is 100. Description of Sites: The study is carried out at Vietnam National Children's Hospital. Description of Study Intervention: Totally 100 eligible patients are divided randomly into 2 groups (n = 50/group each): Patients in Control group received the routine treatment and three times per day 0.9% NaCl physiological saline while the and patients in Navax group received three times per day LiveSpo Navax in addition to the same standard of care treatment. The standard treatment regimen is 3-6 days but can be extended further depending on the severity of the patients' respiratory failure. Study Duration: 12 months

NCT ID: NCT05156723 Completed - COVID-19 Clinical Trials

Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.

Start date: July 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A two-stage trial will involve healthy volunteers. The first stage is open trial, and the second stage is a double-blind trial with randomization of volunteers into three groups. At stage I of the trial, the maximum number of screened healthy volunteers will be 30 of which 20 men aged 18 to over 60 years. At stage II of the trial, the maximum number of screened healthy volunteers will be 150, of which 135 men and women aged 18 to over 60 years eligible according to the inclusion and exclusion criteria are planned to be included and randomized to collect data that will be used for the subsequent safety and immunogenicity assessment. The enrollment of volunteers at stage II will be competitive.

NCT ID: NCT05152849 Completed - Clinical trials for Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection

Efficacy, Safety, Tolerability of AXA1125 in Fatigue After COVID-19 Infection

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.

NCT ID: NCT05148780 Completed - Clinical trials for Acute Respiratory Infection

A Study of Acute Respiratory Infections in Global Outpatient Setting

ARGOS
Start date: December 20, 2021
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.

NCT ID: NCT05148676 Completed - COVID-19 Pandemic Clinical Trials

Residual Symptoms and the Quality of Life in Individuals Recovered From COVID-19 Infection: A Survey From Pakistan

Start date: November 1, 2020
Phase:
Study type: Observational

There remains scarcity of literature regarding the patient's health status post-COVID-19 infection. This study analyzes the prevalence of residual symptoms and quality of life (QoL) after COVID-19.

NCT ID: NCT05142748 Completed - Clinical trials for Kidney Transplant Infection

Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital

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

The investigators aimed to identify prognosis factors associated with in-hospital complications and assess the epidemiology, management, and outcomes of community-acquired pneumonia in a kidney transplant recipients' cohort. The investigators intend to identify each stay by a national database. Then they will be consulted by 2 clinicians to assert CAP clinical definition. After that radiographic evidence will be reviewed to validate CAP diagnoses. Then clinical data are collected in each center.

NCT ID: NCT05135455 Completed - Clinical trials for Prevention of Infectious Disease Caused by SARS-CoV-2

VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA

Start date: April 21, 2022
Phase:
Study type: Observational

This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination. The present study aims to collect information on serious adverse events or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

NCT ID: NCT05134766 Completed - Clinical trials for Acute Upper Respiratory Tract Infection

Retrospective Evaluation of Clinical, Virological and Serological Data in Patients With Mild Acute Upper Respiratory Tract Infections

Start date: January 1, 2021
Phase:
Study type: Observational

Retrospective analysis with subgroup evaluation Primary objectives of the data analysis study: 1 Retrospective analysis of the symptoms and quality of life data of patients with mild, acute (<96 hours) upper respiratory symptoms based on the results of standard health assessment questionnaires used at the institution, over a period of 10-15 days after the SARS CoV-2 PCR test. Secondary objectives 1 Retrospective assessment of the upper respiratory tract symptoms and quality of life and serological parameters of the contact persons with confirmed close exposure to SARS CoV-2 PCR positive patients (based on the results of the standard health assessment questionnaires used at the institution in the period of 10-15 days after the SARS CoV-2 PCR test) The retrospective analysis also includes an assessment of the pharmacological and supplementary therapies used in patients presenting with mild, acute (<96 hours) upper respiratory symptoms and SARS CoV-2 positive contacts, as well as the incidence of SARS CoV-2 virus infection in contacts confirmed by PCR test (based on values measured within 48 hours and 10-15 days later), and an analysis of patients' serological data.