A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Bacteremia Due to S....
Staphylococcal InfectionsBacteremiaThe purpose of this study is to establish the tolerability of treatment with human lactoferrin 1-11 peptide (hLF1-11) administered intravenously as a single dose given for 10 consecutive days, to patients with bacteremia due to staphylococcus epidermidis.
Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions
Methicillin-Resistant Staphylococcus AureusThe purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland.
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
Staphylococcus AureusThis study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.
A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by...
InfectionThe purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, Lactobacillus rhamnosus versus oral placebo for reducing colonization by MRSA.
Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus...
Staphylococcal InfectionsThe purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).
V710 First-In-Man (FIM) Study (V710-001)
Staphylococcal InfectionsThis is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled, dose-ranging study in healthy adults 18 to 55 years of age. It is the first in man (FIM) study evaluating the tolerability and immunogenicity of the 0657nI S. aureus vaccine. For this Phase I study, approximately 120 healthy adults will be enrolled in the study and randomized to receive a single 0.5 mL vaccination of either 0657nI S. aureus vaccine (3 different dosage levels of 5 μg, 30 μg or 90 μg of the 0657nI vaccine) or saline placebo. Vaccine/placebo will be administered intramuscularly (IM) in the deltoid muscle. Because this study will be the first study evaluating the tolerability and immunogenicity of 0657nI S. aureus vaccine in humans, a dose-escalation phase will be conducted in a small number of subjects randomized in a 3:1 ratio (n=36, consisting of 9 subjects for each of 3 vaccine dosage levels and 9 placebo subjects) to evaluate the vaccine safety at increasing dose levels of the 0657nI protein in Panel A, before expanding the enrollment to the remaining 84 subjects in Panel B.
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant...
MRSA ColonizationTrial Objectives: Primary objective: To evaluate the efficacy of Bio-K+CL1285® in patients with Methicillin-Resistant S. aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either Bio-K+CL1285® or placebo treatment. Secondary objective: To evaluate the safety profile of Bio-K+CL1285®.
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
Staphylococcal InfectionsYeast Infections1 moreThis partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.
Evaluation of Manufacturing Lot of StaphVAX
Staphylococcal InfectionsChronic Kidney FailureThis study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.
StaphVAX in Cardiovascular Surgery Patients
Staphylococcal InfectionsCardiovascular Diseases1 moreS. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.