A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis...
Staphylococcus Aureus InfectionThis is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.
The Benefit of FDG PET CT in the Treatment Algorithm of Staphylococcus Aureus Bacteremia
Staphylococcus Aureus BacteremiaBackground: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals, with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB, other than in cases of Infective endocarditis (IE), recommended by different guidelines relies on risk stratification for relapse of infection rather than definite diagnosis of septic foci that eventually determine the relapse rate. In recently published studies fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying metastatic infectious foci in Gram-positive bacteremia, including SAB. Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE SAB compared to standard treatment recommendations on treatment duration and clinical outcomes. Methods: A prospective interventional non-comparative cohort study conducted at Rambam Health Care Campus. Patients with SAB, defined as microbiologically and clinically, will undergo FDG PET CT 10-14 days following the first positive blood culture for diagnosis of septic extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks) versus long treatment (4-6 weeks) will be recommended for negative and positive PET CT tests, respectively. Patients will be followed-up for 1 year for relapse of infection and mortality. We will document the sensitivity and specificity of PET CT for detection of complications among patients with SAB. We will examine the percentage of patients in whom the use of PET CT changed treatment duration compared to standard recommendations. We will compare also, the relapse rate and 1 year mortality rate with data from previous studies and local data. Assuming a 15% rate of management changes compared to consensus recommendations, a sample of 150 patients will achieve the required 95% CI. Significance: Our trial will serve for improving decision making in patients with non-IE SAB, shortening treatment duration in unnecessary cases and decreasing relapse rate by giving prolonged appropriate treatment for metastatic infection not identified by standard management algorithms. PET CT is assuming an increasingly important role in infection diagnosis and management. The current study will be the first to examine the role of PET CT in directing management of patients with SAB.
Photodisinfection for the Decolonization of Staphylococcus Aureus in Hemodialysis Patients
Staphylococcus Aureus InfectionMSSA ColonizationThe purpose of the study is to evaluate whether PDT (MRSAid™) is effective in eradicating SA from hemodialysis patients who are known to harbor this organism inside their nose.
A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
Staphylococcus Aureus InfectionThis is an open-label, dose-escalation pilot study with a total of 30 participants with 10 per dosage group. The aim of the pilot study is to explore the preliminary safety of an experimental recombinant staphylococcus aureus vaccine.
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
Cross InfectionStaphylococcal InfectionsIn order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent Staphylococcus aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections.
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates...
Staphylococcal InfectionsThe main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.
Targeted Gown and Glove Intervention in Nursing Homes
Staphylococcus AureusCarbapenem Resistant Gram Negative BacteriaThis project will assess the feasibility of a cluster-randomized trial with crossover of our intervention, targeted gown and glove use, among high-risk residents of community nursing homes to prevent Staphylococcus aureus and carbapenem gram negative bacteria acquisition and infection.
Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine...
Staphylococcus AureusS. aureus is a leading cause of severe infections notably in haemodialysis patients. These patients have a high risk of S. aureus nasal carriage, with a rate of persistent carriage near 30%. These carriers are particularly at risk of S. aureus infections as we previously shown. High risk of S. aureus infections such as bacteremia occurred notably in patients with dialysis catheters. Decolonization of carriers may prevent such infections however this approach has limits. Development of an effective S. aureus vaccine is crucial. To date, past vaccines tested (phase III) failed to achieve their end points. Target of only one or few antigens, absence of cellular response induction and possibly no impact on carriage are probably the reasons of the failures.
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia
Staphylococcus Aureus BacteraemiaSafety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia. The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus bacteremia.
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy...
Staphylococcus AureusThis is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.