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Communicable Diseases clinical trials

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NCT ID: NCT05121025 Recruiting - Clinical trials for Helicobacter Pylori Infection

Pathogen-microbiome Interaction During Helicobacter Pylori Infection

PREDICTHP
Start date: March 11, 2022
Phase:
Study type: Observational

Helicobacter pylori affects the gut microbiome in ways that are only partially understood. In which patients H. pylori causes severe disease and in whom it merely colonizes, possibly even with beneficial effects, is not understood. The investigators are pursuing the hypothesis that changes in the gut microbiome that can be easily measured in stool have such predictive value.

NCT ID: NCT05117398 Recruiting - Clinical trials for Staphylococcus Aureus Infection

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

DALICATH
Start date: June 23, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit). As the secondary objectives, the study aims to evaluate according to treatment group: 1. Cure rate at DAY 14 and DAY 90 (EOS); 2. Mortality rate within 90 days of follow-up; 3. Time to negativation of blood cultures; 4. Patient's quality of life; 5. Hospitalization length of stay; 6. Cost-utility analyses; 7. Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

NCT ID: NCT05116956 Recruiting - Clinical trials for Necrotizing Soft Tissue Infection

SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study

SKIN-ICU
Start date: November 8, 2021
Phase:
Study type: Observational [Patient Registry]

Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not. The objectives of the study are : 1. To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes 2. To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

NCT ID: NCT05103267 Recruiting - Heart Failure Clinical Trials

Tauropace to Prevent Cardiac Implantable Device Infections in Heart Failure Patients

TRICE-HF
Start date: June 6, 2022
Phase:
Study type: Observational [Patient Registry]

The main purpose of the study is to evaluate the ability of the Tauropace to reduce major cardiac implantable electronic device (CIED) infections through 12-months post-procedure following CIED in heart failure participants. The secondary endpoint is to prospectively characterize the performance of Tauropace in participants whose CIED system includes a transvenous RV defibrillation lead.

NCT ID: NCT05101213 Recruiting - Clinical trials for Malignant Solid Neoplasm

Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients

Start date: January 6, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.

NCT ID: NCT05100446 Recruiting - Gastric Cancer Clinical Trials

Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection

Start date: May 1, 2021
Phase: Early Phase 1
Study type: Interventional

Helicobacter pylori is a pathogenic bacteria transmitted from individual to individual, being scientifically recognized as an agent who causes persistent inflammatory activity on the gastric mucosa. This pathogen represents a Global Health problem, as shown in a systematic review by Hooi et al. Besides regional differences, more that half of the world population is expected to have already been infected by this bacteria. In Portugal, research studies estimate that more than 80% of the adult population has already contacted with H. pylori. H. pylori infection is associated with active chronic gastritis in every colonized patient, what may consequently lead to peptic ulcer disease, atrophic gastritis, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. For that reason, H. pylori infection is considered to be a disease, independently of the presence of gastrointestinal symptoms. Additionally, H. pylori has been classified as a confirmed carcinogen (class I) by the International Agency for Research, being responsible for carcinogenic pathways conducting to both gastric adenocarcinoma and lymphoma. This fact gains a particular relevance taking into account that gastric cancer is one of the most prevalent cancers worldwide. On other hand, more than 75% of the gastric cancers occur following H. pylori infection. Thus, H. pylori eradication constitutes an essential Public Health measurement, being inclusively considered a cost-effective method to decrease the gastric cancer burden, by promoting pre-malignant lesions regression, such as atrophic gastritis, and by delaying the disease progression in case of intestinal metaplasia or dysplasia. Maastricht V consensus is a document updated in 2016, including the major recommendations regarding H. pylori diagnosis, follow-up and treatment. It highlights the emergence of antibiotic resistances and how they must influence clinical practice, namely the choice of antibiotic regimens, as successful eradication has become less frequent with more prevalent antibiotic resistances. This is the case of clarithromycin and metronidazol, both currently recommended as first-line options by the Portuguese Society of Gastroenterology. In fact, a systematic review conducted in 2018, aiming to evaluate antibiotic resistances on the Portuguese population observed that clarithromycin, metronidazole and double resistance occurred in 42%, 25% and 20% of the individuals, respectively. Nowadays, Maastricht V guidelines recommend quadruple regimens containing bismuth, such as Pylera (r), as the first-line option in areas with significant double resistance to metronidazole and clarithromycin. Another option currently being investigated is the double therapy with amoxicillin in high doses and proton pump inhibitor. This has become a particularly attractive alternative due to its efficacy, good tolerability and significantly low resistance (<1%) among the European population. The aim of this clinical trial is to compare both regimens - pylera (r) and high-dose amoxycillin - in H. pylori eradication, regarding their efficacy, tolerability and side effects, in order to asses viable therapeutic options in a population with progressively increasing resistances to alternative regimens currently recommended.

NCT ID: NCT05097677 Recruiting - Covid19 Clinical Trials

Follow-up of Covid-19 Long Term Sequelae

Start date: April 16, 2021
Phase:
Study type: Observational [Patient Registry]

The protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management and prevention of COVID-19 sequelae. The follow-up will be organized in multiple levels of tests, according to the capability of each cohort, and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to the vaccination and to different treatment strategies, including monoclonal antibodies.

NCT ID: NCT05092074 Recruiting - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection

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

The investigators aim to assess the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks in hepatitis C virus (HCV)-infected patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen in Taiwan on a basis of a multicenter observational study.

NCT ID: NCT05090319 Recruiting - Clinical trials for Infection, Bacterial

Micro-hematology Analyzer for Viral/Bacterial Description

Start date: July 25, 2021
Phase:
Study type: Observational

The purpose of the study is to evaluate the reliability and accuracy of a newly developed point-of-care analyzer, theCytoTracker, to measure complete blood count (CBC) parameters and discriminate between viral and bacterial infections.

NCT ID: NCT05086887 Recruiting - Malaria Clinical Trials

Infections in Migrants in Sweden - the Importance of Malaria and Other Parasitic Infections

MMS
Start date: April 15, 2019
Phase:
Study type: Observational [Patient Registry]

Malaria is a parasitic disease causing substantial morbidity and mortality globally. Malaria is a potentially severe and fatal disease in non-immune individuals. In areas of intense transmission infections individuals acquired immunity that protect against clinical disease. Nonetheless, immunity is not regarding sterilizing and repeated infections often result in an asymptomatic carriage of malaria parasites. These chronic apparently asymptomatic infections have been associated with anemia, cognitive dysfunction and adverse events during pregnancy. Global migration has increased over the last decade and has resulted in an increasing number of migrants from malaria endemic regions arriving in non-endemic countries. Migrants from malaria endemic countries may carry asymptomatic infections with malaria parasites, as well as other parasitic infections such as strongyloides and schistosomiasis, with a possible negative impact on health in this group. The prevalence of asymptomatic malaria and other parasites is not fully elucidated in migrants from different regions. Moreover, the longevity of asymptomatic carriage of malaria parasites in absence of re-exposure is not known. The aim of this study is to assess the prevalence of malaria parasites and other parasitic infections in migrants in Sweden, both newly arrived and migrants with longer residency, and intend to evaluate the need for screening for various parasitic infections in migrants arriving in Sweden. Moreover, this study will also assess antibody responses to malaria and other parasitic diseases.