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Communicable Diseases clinical trials

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NCT ID: NCT04803435 Not yet recruiting - Clinical trials for Gastrointestinal Infection

Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Gastrointestinal Infection Patients

Start date: February 20, 2022
Phase: N/A
Study type: Interventional

Acute gastroenterocolitis (GECA) in healthy adults is a frequent cause of looking for medical care in emergency care units and most cases are aimed at etiology viral infection or food toxin, being generally self-limited with good prognosis and only need for treatment with behavioral measures and use of medications for relief symptomatic. Anamnesis is the main resource for the diagnosis and stratification of GECA severity and is infrequent alterations of physical examination and complementary examinations without association with symptoms of alert. Telemedicine has become a resource that allows easier and faster access to medical evaluation, with low cost and rational use of resources. Virtual emergency care is part of Hospital Israelita Albert Einstein (HIAE) institutional routine and there is a large number of consultations whose final diagnosis was GECA. It is not known whether the accuracy of diagnosis of GECA by telemedicine is not inferior to the diagnosis by face-to-face evaluation, considered the Golden pattern. The aim of the study is compare the diagnostic accuracy of GECA by telemedicine with that of face-to-face care. It is a prospective randomized study with a population of adult patients who sought in person the screening of the Morumbi Emergency Care Unit of HIAE with symptoms suggestive of GECA (diarrhea with or without other symptoms of the digestive tract and infectious). Patients whose screening will be excluded of nursing directed for immediate evaluation in the emergency room and patients with dysfunctions organisms or immunosuppression. Patients who accept and sign the informed consent form will be randomized into 2 groups: A) immediate face-to-face evaluation; B) evaluation initially by telemedicine and sequentially at face-to-face evaluation. In both cases, the ICD diagnostics will be compiled and grouped according to clinical significance and will be the primary outcome of the study. Service time, exams requested, guidelines, prescription and destination will also be analyzed. Patients and doctors who undergoing group B assessment will be blinded to the telemedicine assessment data.

NCT ID: NCT04802837 Terminated - Clinical trials for Clostridioides Difficile Infection

Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Ri-CoDIFy 3
Start date: May 19, 2021
Phase: Phase 3
Study type: Interventional

Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

NCT ID: NCT04802382 Active, not recruiting - Covid19 Clinical Trials

Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19

CimetrA
Start date: June 11, 2021
Phase: Phase 3
Study type: Interventional

A preparation of CimertrA, comprising Artemisinin, Curcumin, and Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel coronavirus SARS-CoV-2. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. The severe acute respiratory syndrome-associated coronavirus disease 2019 (COVID-19) illness results from the immediate response to the viral infection as well as from a subsequent host inflammatory response. Systemic proinflammatory cytokines and biomarkers are elevated as the disease progresses towards its advanced stages, and correlate with worse chances of survival. Serum cytokine levels that are elevated in patients with Covid-19-associated cytokine storm include interleukin-1β, interleukin-6, IP-10, TNF, interferon-γ, macrophage inflammatory protein (MIP) 1α and 1β, and VEGF. Higher interleukin-6 levels are strongly associated with shorter survival. The relative frequencies of circulating activated CD4+ and CD8+ T cells and plasmablasts are increased in Covid-19. In addition to the elevated systemic cytokine levels and activated immune cells, several clinical and laboratory abnormalities, such as elevated CRP and d-dimer levels, hypoalbuminemia, renal dysfunction, and effusions, are also observed in Covid-19. Laboratory test results reflecting hyper inflammation and tissue damage were found to predict worsening outcomes in Covid-19. CimetrA, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, has been studied on patients with COVID-19 in a randomized double-blind control Phase II study (MGC-006 - under a previous product name - ArtemiC). The study product demonstrated excellent safety and efficacy profiles. Experiments performed in vitro with CimetrA demonstrated the ability to reduce cytokine elevation in response to stimulation of human PBMC preparations. The currently proposed Multi-center multinational-controlled study is designed to include 252 adult patients who suffer from moderate COVID-19 infection. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments, and vital signs. After the screening visit, the study drug will be administrated twice a day morning and evening (every 12 hours) during (day 1 and day 2) The patients will be randomized in 1:1:1 ratio to study drug (CimetrA) in addition to Standard of Care (Arm 1 (CimetrA-1) or Arm 2 (CimetrA-2)) or Placebo in addition to Standard of Care (Arm 3).

NCT ID: NCT04801862 Recruiting - Clinical trials for Clostridium Difficile Infection

Natural History of Clostridioides Difficile Infection

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Aim: To investigate if host factors, such as composition and diversity of intestinal microbiota and/or genetic determinants, are associated with a higher risk of recurrence of Clostridioides difficile infection (CDI). To generate a predictive tool based on epidemiological, clinical, genetic and microbiologic variables aimed to identify patients at a higher risk of CDI recurrence in a context of optimized ICD management. Design: Multicenter prospective cohort study. Patients: Older than 18 years patients with CDI diagnosis, made by IDSA criteria, in the participant centers. Follow-up: A stewarship program aimed to improve CDI management, including early detection of CDI recurrence, will be implemented in the participant centers. Blood samples for genetic testing and stool samples for intestinal microbiome studies will be collected. Variables and data analysis: The primary outcome variable will be the emergence of CDI recurrence. Potential independent predictors of recurrence, including genetic and microbiological factors, will be assessed. A predictive tool based on independent predictors of recurrence will be built in a development subpopulation. The performance of the model will be assessed by ROC curves, and sensititvity, especificity, as well as negative and positive predictive values will be calculated, both in the development subpopulation and in a validation subset.

NCT ID: NCT04801667 Active, not recruiting - Clinical trials for Coronavirus Infection

Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients

TXCoronavac
Start date: March 20, 2021
Phase: Phase 4
Study type: Interventional

Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reaching 53% among those over 70 years old. Among the survivors, there is also a high incidence of renal dysfunction with loss of the renal graft and definitive return to dialysis. Patients receiving pharmacological immunosuppression, including transplant recipients, have not been included in the studies carried out to date. In addition, kidney transplant recipients may have reduced vaccine responses compared to the general population. The severity, the high incidence of renal dysfunction and loss of renal graft, and the high lethality associated with COVD-19 justify the investigation of the epidemiological impact and immunogenicity of the vaccine against SARS-CoV-2 infection.

NCT ID: NCT04801615 Recruiting - Clinical trials for Necrotizing Soft Tissue Infection

Characteristics of Patients With Necrotizing Soft Tissue Infections

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

To study the demographic characteristic of patients with necrotizing soft tissue infections.

NCT ID: NCT04799223 Completed - Obesity Clinical Trials

Personalized Modulation of Microbiota

NUTRIBIOTA
Start date: November 15, 2020
Phase: N/A
Study type: Interventional

Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a symbiotic relationship with the human body. It is estimated that human beings have around 2,000 different bacteria species. The gut microbiota plays a key in many of the body's functions. Hence, the analysis of the gut microbiome provides insight into the state of the microbiota as an indicator of overall health due to its metabolic, protective and nutritional functions. A balanced diet promotes the formation and maintenance of a well-structured microbiota, in which the different species of microorganisms cohabit in a balanced and controlled system. The study is based on the hypothesis that the intake of certain plant-based foods rich in various active ingredients (especially non-digestible carbohydrates, certain types of fats and polyphenols) can modulate the microbiota and thus improve the health status of the human population. Taking into account this background, the objective of this study is to assess the effect of the inclusion of functional foods and ingredients within a balanced diet on the composition of the microbiota and also on health parameters associated with metabolic disease.

NCT ID: NCT04796285 Active, not recruiting - Sepsis Clinical Trials

A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The overall purpose of this study is to demonstrate the usability of a clinical-grade device in the form of a finger clasp similar to a pulse oximeter for monitoring lactate values, by comparing its performance in reading interstitial fluid lactate values against a known clinical standard in the form of venous lactate levels. Serum lactate measurements are used clinically as a measure of end-organ dysfunction and physiologic stress. Changes in lactate may indicate worsening infection in the setting of sepsis, drug toxicity for certain xenobiotics, or exercise tolerance in exercise physiology. Serum lactate cutoffs have been developed for various disease states and trigger a variety of medical decisions directed at managing the course of the disease. A common theme in the application of lactate measurements to understanding changes in physiology is the need to obtain venous blood to determine lactate. While point-of-care assays have been developed that improve the processing speed, there continues to be a need to obtain fingerstick blood or in most cases, venous blood. Obtaining venous blood for serum lactate requires an individual with phlebotomy skills, the processing capabilities of a laboratory to determine lactate concentrations, or the availability of point of care technology. An alternative method to measure lactate is to sample interstitial fluid which surrounds cells and tissues in the body. Obtaining interstitial fluid is potentially less invasive without the need for repeat phlebotomy or the presence of an indwelling intravenous catheter which can become complicated by infection. The analysis of interstitial fluid for glucose has been validated and is clinically utilized in continuous glucose monitors in individuals with diabetes. In this investigation, the investigators will utilize a novel device, the Lab Clasp to obtain interstitial fluid in a noninvasive method. The Lab Clasp is manufactured to resemble a finger pulse oximeter with additional onboard microfluidics channels that obtain a lactate concentration from interstitial fluid. This streamlined process of obtaining the point of care lactate measurements on demand allows for tasks like serial lactate measurements to be accomplished on a reliable schedule with less workload for nursing staff typically required to draw venous blood. Additionally, the portable and noninvasive nature of the Lab Clasp system may render it usable in facilities that lack skilled staff necessary to perform phlebotomy.

NCT ID: NCT04793997 Suspended - Clinical trials for Corona Virus Infection

Microbiome Therapy in Covid-19 Primary Care Support

MiCel
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This double-blind, randomized, placebo-controlled study aims to investigate whether a throat spray containing probiotic bacteria (i.e. microbiome spray) can reduce the symptoms and complaints of the SARS-CoV-2 virus in patients with mild to moderate symptoms. In addition, the aim is to investigate whether the microbiome spray can prevent transmission of the SARS-CoV-2 virus to household members.

NCT ID: NCT04791098 Recruiting - Clinical trials for Kidney Transplantation

Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

PREVAGREF
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.