View clinical trials related to Infections.
Filter by:Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.
Approximately 2 billion people worldwide are infected with Mycobacterium tuberculosis (TB), with 90% of individuals having latent infection (LTBI). The control of TB requires clearly delineated helper T cell (Th) 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and in the prevention of active disease, as seen in LTBI. During latency, M. tuberculosis is contained in localized granulomas. Mycobacteria specific T cells mediate delayed type hypersensitivity reactions to purified protein derivative (PPD), and this reaction is generally considered to indicate an LTBI status in the absence of demonstrable active infection. Among the various risk factors that are known to play a role in promoting active TB, HIV is the most well studied and described. However, in low-HIV-endemic countries like India, other risk factors might play a more prominent role in active TB pathogenesis. These include malnutrition, diabetes mellitus (DM), and helminth infections. LTBI individuals with these comorbidities or coinfections could be at a higher risk for developing active TB than their "healthy" LTBI counterparts without these comorbidities. Thus, it is imperative to study the pathogenesis of TB infection and disease in these "at risk" populations. In this study, we will estimate the prevalence of severe to moderate malnutrition, uncontrolled DM, and helminth infections in LTBI-positive individuals. We will collect samples from a cohort of individuals with LTBI, those with LTBI and coexistent malnutrition, DM, or helminth coinfection, and those without any of these conditions. Individual participation may last up to 6 months. The main objective of the study is to estimate the prevalence of malnutrition, DM, and helminth infections in LTBI individuals. Simultaneously, we will perform transcriptomic, proteomic, and metabolomic assays, including profiles in serum and urine, to determine the biosignature portfolio of these individuals. In addition, immunological assays examining cytokine/chemokine signatures as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross talk between LTBI and malnutrition, DM, and helminth infections.
This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine the safety and the optimal dose of the GEO-CM04S1 vaccine. The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel, study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single booster shot to assess the immune response measured by the fold-increase in antibody against SARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.
Since 1996, HAART based on 3-drug regimens (3DR) in people living with HIV (PLHIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term antiretroviral therapy (ART). Two-drug regimens (2DRs) have been investigated as a means for reducing the number of antiretroviral agents (ARVs) taken by individuals who need lifelong ART. Dovato® (Dolutegravir/lamivudine) has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US Food and Drug Administration (FDA) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato ® as an initial treatment in HIV-naÏve patients. However there is no real- life cohort data. Our aim is to provide information related to effectiveness and tolerability/safety in naïve patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients. Our results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with dolutegravir (DTG) + lamivudine (3TC), to verify efficacy and tolerance in real life. Our hypothesis is that the data will be similar to those reported in clinical trials.
Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1. To explore HBsAg loss and kinetics during the study period 2. To assess the anti-viral effect during the study period 3. To evaluate the rate of ALT normalization
2.1. Study Objectives - Primary Objective(s) - Identify the incidence and risk of CDI within one year after kidney, liver, and/or pancreas transplant - Secondary Objective(s) - Identify the risk factors for recurrent CDI post-transplant in patients who were diagnosed with a CDI within one year prior to Solid Organ Transplant - Evaluate the impact of CDI on graft survival following Solid Organ Transplant
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
Introduction. Some issues remain to be elucidated about SARS-CoV-2 infection to plan prevention interventions based on scientific evidence, such as the actual prevalence of infection including subclinical and seroconverted cases, the reasons for the different spread and severity of the infection in different subjects and geographical areas as well as the impact of the COVID-19 crisis on the health of healthcare professionals and in the general population. The aims of this project are: (i) to estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection,in Lombardia region and Molise region, respectively; focusing on subgroups at higher risk such as healthcare workers (HCWs); (ii) to estimate the incidence of burnout and post-traumatic stress disorder in HCWs; (iii) to identify factors associated with SARS-CoV-2 infection positivity and to follow up its mid-term effects on health. Methods. Participants will be randomly selected from the general population of both territories and from the HCWs list of the two healthcare facilities involved. SARS-CoV-2 IgG and IgM blood levels will be measured and anamnestic data will be collected through computerized tools. Prevalence of currently or previously infected subjects and their disease status and severity will be estimated and the association with potential risk factors will be analyzed through multivariable regression analyses. Expected results. The study will identify the burden of the infection in the general and HCWs populations. It will also identify the determinants of differences in the spread and severity of the infection, to hypothesize new preventive or therapeutic interventions. This study will provide a basis for monitoring the progress of the infection and its medium-term health consequences, Finally it will allow planning future studies, through analyses in biological samples which will be collected in dedicated biobanks.
SAINT-PERU is a triple-blinded, randomized placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.
The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.