Infectious-diseases Clinical Trials

21:56 EDT 19th October 2018 | BioPortfolio

Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)

The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the treatment of acute infections or for prophylaxis of febrile neutropenia.

Immunization Schedule Alert Platform

The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.

Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending o...

Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019

• This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postc...

Reducing the Burden of Influenza After Solid-Organ Transplantation

Influenza is associated with significant morbidity and mortality in solid-organ transplant (SOT) recipients and it is mainly prevented by seasonal influenza vaccination. Unfortunately, the immunogenicity of standard influenza vaccine is suboptimal in this population. Vaccination with a high-dose (HD) influenza vaccine or an MF59-adjuvanted (MF59a) vaccine have significantly...

Immune Response to Influenza Vaccine in Adults With B-cell Malignancies Treated With Idelalisib

The primary objective of this study is to assess the immune response to an influenza vaccine in adults with B-cell malignancies who are currently receiving treatment with idelalisib in a Gilead-sponsored study (parent study).

Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response

The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant.

Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

The objectives of this study are: - To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study - To describe the antibody response induced by each dosage of QIV-HD use...

Triple Antimalarial Combination to Accelerate the Parasite Clearance and to Prevent the Selection of Resistant Parasites

The purpose of this study is to provide a new drug combination for a better treatment of P. falciparum for a faster parasite clearance and to counteract artemisinin resistance.

Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves

The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (1...

FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care

Adjuvanted flu vaccine, Fluad, is not immunologically inferior to HD influenza vaccine in older persons living in long-term care.

Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly

To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly

Study of Anti-PSMA CAR NK Cell in Castration-Resistant Prostate Cancer

This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-PSMA CAR NK cells in patients with castration-resistant prostate cancer.

Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years

The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it ...

Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety

The objective of this study is to assess whether intake of baked and then chilled potatoes over a 24-h period, compared to intake of isocaloric, carbohydrate (CHO)-matched foods low in fiber and resistant starch (RS), will increase insulin sensitivity, breath hydrogen and satiety, and decrease hunger and free fatty acid (FFA) levels in overweight or obese men and women at r...

Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in G...

The Impact of Imprinting and Repeated Influenza Vaccination on Adaptive Immunity, Transcriptomics, and Metabolomics

The goal of this study is to understand the impact on the human immune system's response to the 4 strain flu vaccine in individuals who have "imprinted" on specific influenza strains. It will also consider the effects of repeated prior annual influenza vaccination on the immune system.

Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children

to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants

Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study

This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP). This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.

Effect of Influenza Vaccination or Infection on the Development of Protective Immunity in Children

This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 160 subjects. 80 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 20 children greater than 12 months of age and born aft...

PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)

Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. pip...

CT18 Infant Influenza Priming Study in Vaccine Naive Infants

This study evaluates whether priming influenza naive infants, age six to 23 months, with a MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. All participants will receive a priming vaccine, either MF59-adjuvanted trivalent influenza vaccine (aTIV) or unadjuvanted quadrivalent influenza vacci...

Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study

This study will evaluate the safety and tolerability of a dietary fiber, resistant maltodextrin, in people with Parkinson's disease. It will also evaluate the fiber's effect on the gut microbiome and potential effects on motor function and non-motor functions. Half of the participants will receive resistant maltodextrin and the other half will receive a control substance, m...

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