Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection
Helicobacter Pylori InfectionThis study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)
Novel Experimental COVID-19 Therapies Affecting Host Response
COVID-19SARS-CoV-2 Infection1 moreThe overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
Infections and InfestationsPulmonary TuberculosisThis trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose Bedaquiline, Delamanid and Moxifloxacin alone
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
PneumonitisSARS-CoV InfectionThis clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens...
Urinary Tract InfectionAcute Pyelonephritis4 moreThis is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection...
Chronic HBV InfectionThe primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection.
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
Clostridium Difficile InfectionInfection1 moreThis is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell...
Viral InfectionsBone Marrow Transplant InfectionThis Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors. In this trial, we will utilize a rapid generation protocol for broad spectrum multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3, or with PCR/culture confirmed active infection(s) of EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). These cells will be derived from HSCT donors, and the study agent will be assessed at each dose for evidence of dose-limiting toxicities (DLT). This study will have two arms: Arm A will include patients who receive prophylactic treatment, and Arm B will include patients who receive VSTs for one or more active infections with targeted viruses. Determination of the study arm will be determined by the patient's clinical status. Study arms will each be analyzed for safety endpoints and secondary endpoints.
Motivational Intervention on the Gut Microbiota of Obese Children
Microbial ColonizationAnimal models and studies on small samples of obese adults have shown that gut microbial diversity and certain types of bacteria could predict the efficacy of the dietetic treatment to improve body mass index (BMI) and the components of metabolic syndrome (MetS). Gut microbiota could distinguish the obese with metabolic syndrome patient than that metabolically healthy. Dietetic therapy could induce changes in the microbiota that could lead to improvement of BMI and the components of the MetS. The aim of MICROBEkids is to test whether the motivational intervention a motivational intervention (OBEMAT2.0) (PI15/00970) is more effective than the conventional intervention to increase the gut microbial diversity and, as a consequence, to improve BMI and MetS components. The role of gut microbiota (through modulation of the short chain fatty acids) will be analyzed as cardiovascular risk factor and as predictor of treatment success. These objectives will be achieved through a clustered clinical trial design with an intervention group that will receive a motivational therapy compared to a control group that will receive a conventional intervention, both during 12 months. The study sample are 319 children (n= 167 in the intervention group) that were enrolled in the clinical trial OBEMAT2.0 (PI15/00970), have had a comprehensive clinical assessment before the intervention (ages 8 to 14) and after 12 months (+3) of therapy (ages 9 to 15) and furthermore have participated in a biological samples collection for the investigation on childhood obesity (COLOBEPED, reference C.0004585).
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem...
Cytomegalovirus InfectionsAdenovirus Infection1 moreThe purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.