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Staphylococcal Infections clinical trials

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NCT ID: NCT01447407 Completed - Candidiasis Clinical Trials

Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This 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.

NCT ID: NCT01438515 Completed - Clinical trials for Methicillin-resistant Staphylococcus Aureus

Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

Start date: August 2008
Phase: N/A
Study type: Interventional

MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population. Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.

NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01419184 Completed - Clinical trials for Staphylococcal Skin Infections

Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

DAPHEOR1006
Start date: September 9, 2011
Phase: Phase 4
Study type: Interventional

This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.

NCT ID: NCT01379053 Completed - Clinical trials for Staphylococcus Aureus

Volatile Organic Compounds in Staphylococcus Aureus Patients

MRSAVOC
Start date: August 2009
Phase: N/A
Study type: Observational

The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists of: - A collection apparatus for collection of volatile compounds from suspected infection sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate sample of room air. - Analysis of the volatile organic compounds from suspected infection sites and room air by short acoustic wave gas chromatography. - Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of Staphylococcus aureus infection and colonization. This study will test the hypothesis that we can identify the presence of MRSA by sampling the "head space" above culture media of anterior nare samples provided by patients with MRSA. Additionally, this study will test the hypothesis that we can identify the presence of MRSA by sampling air exhaled through the nostrils (nasal exhalant).

NCT ID: NCT01375621 Completed - Clinical trials for Staphylococcus Aureus Infection

Livestock Contact and MRSA in Rural Areas

Start date: June 1, 2011
Phase:
Study type: Observational

Background: - MRSA is a type of bacteria that causes serious health problems. It can cause severe infections and is difficult to treat. MRSA has been found in a high number of people who work with some kinds of livestock, such as pigs. Researchers want to study people in rural areas, where more people work with or around livestock. They want to see if MRSA is more common or causes more serious infections in these areas. Objectives: - To look at the relationship between livestock handling (especially pigs) and MRSA bacteria in people in rural areas. Eligibility: - Participants in the Agricultural Health Study in Iowa, including those who are exposed to livestock. - Healthy volunteers who are not exposed to livestock. Design: - This study requires an initial visit and monthly follow-up surveys for 18 months. - At the first visit, participants will have throat and nose swabs to collect cell and bacteria samples. They will also complete a questionnaire about their health habits. Other questions will ask about any work that brings them into contact with livestock like cows, pigs, or chickens. - Every month for the next 17 months, participants will complete another questionnaire to record any changes in their health and livestock contact information. They will also collect throat and nose swabs. They will send the questionnaires and the swabs to the study researchers. - Participants will be paid for the first visit and for every monthly survey and swab collection they return. - No treatment will be given as part of this protocol.

NCT ID: NCT01364571 Completed - Clinical trials for Staphylococcal Infections

Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to <65 years.

NCT ID: NCT01350479 Completed - Clinical trials for Methicillin-Resistant Staphylococcus Aureus

Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

Start date: October 1, 2012
Phase: N/A
Study type: Observational

Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized Veterans in community living centers.

NCT ID: NCT01349192 Completed - Cystic Fibrosis Clinical Trials

Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)

STAR-Too
Start date: April 2011
Phase: Phase 2
Study type: Interventional

Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA. Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit. Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.

NCT ID: NCT01324440 Completed - Clinical trials for Staphylococcal Infections

Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)

Start date: September 2006
Phase: Phase 1
Study type: Interventional

The 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).