Archive for January 30, 2014

Methicillin-Resistant Staphylococcus aureus – An Evolving Pathogen

Clinical Infectious Diseases January 2014 V.58 Suppl.1 P.10-19

Martin E. Stryjewski1 and G. Ralph Corey2,3

1Department of Medicine and Division of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno” (CEMIC), Buenos Aires, Argentina

2Division of Infectious Diseases, Duke Clinical Research Institute

3Duke University Medical Center, Durham, North Carolina

Correspondence: Martin E. Stryjewski, MD, MHS, Department of Internal Medicine and Division of Infectious Diseases, CEMIC, Las Heras 2939, 3rd floor, Department of Medicine, Ciudad Autonoma de Buenos Aires (1425) Buenos Aires, Argentina (stryj001@fibertel.com.ar).

Abstract

The horizontal transmission of methicillin resistance to Staphylococcus aureus (MRSA) in hospital and community settings, and growing prevalence of these strains, presents a significant clinical challenge to the management of serious infections worldwide.

While infection control initiatives have stemmed the rising prevalence, MRSA remains a significant pathogen.  More recently, evidence that MRSA is becoming resistant to glycopeptides and newer therapies raises concern about the use of these therapies in clinical practice.

Vancomycin resistance has become evident in select clinical settings through rising MICs, growing awareness of heteroresistance, and emergence of intermediate-resistant and fully resistant strains.

While resistance to linezolid and daptomycin remains low overall, point mutations leading to resistance have been described for linezolid, and horizontal transmission of cfr-mediated resistance to linezolid has been reported in clinical isolates.

These resistance trends for newer therapies highlight the ongoing need for new and more potent antimicrobial therapies.

PDF

http://cid.oxfordjournals.org/content/58/suppl_1/S10.full.pdf+html

January 30, 2014 at 8:58 pm

FDA Guidance for ABSSSI Trials – Implications for Conducting and Interpreting Clinical Trials

Clinical Infectious Diseases January 2014 V.58 Suppl.1 P.4-9

Kamal M. F. Itani1 and Andrew F. Shorr2

1Department of Surgery, VA Boston Healthcare System, Boston University and Harvard University Schools of Medicine, Boston, Massachusetts

2Department of Pulmonary and Critical Care, Washington Hospital Center, Washington, District of Columbia

Correspondence: Kamal M. F. Itani, MD, VA Boston Healthcare System, West Roxbury Campus, 1400 VFW Parkway, West Roxbury, MA 02132 (kitani@va.gov).

Recent guidance from the US Food and Drug Administration (FDA) on the conduct of clinical trials for acute bacterial skin and skin structure infection (ABSSSI) has changed the framework for clinical trial design and conduct. Notable changes included new disease state definitions, new primary endpoint definitions and the timing of assessments at these endpoints, and updated guidance on patient inclusion/exclusion criteria.

Supportive evidence and statistical justification for the proposed noninferiority margins were described in detail. Although the updated guidelines are still considered drafts and have been adopted in some trials, they serve as the basis for study protocol discussions between pharmaceutical companies and the FDA in advancing the development of promising new agents.

Not only will the new trial designs impact researchers and sponsors responsible for drug development programs, but they will also affect healthcare providers participating in clinical trials and the ways in which clinicians develop patient treatment plans based on the results of those trials.

This review provides a summary of key changes that will impact future clinical trial design and outcomes.

PDF

http://cid.oxfordjournals.org/content/58/suppl_1/S4.full.pdf+html

 

January 30, 2014 at 8:55 pm

Tedizolid – A Novel Oxazolidinone for Gram-Positive Infections

Clinical Infectious Diseases January 2014 V.58 Suppl.1 P.1-3

Robert C. Moellering Jr1,2

1Harvard Medical School

2Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts

Correspondence: Robert C. Moellering Jr, MD, Department of Medicine, Beth Israel Deaconess Medical Center, 110 Francis St, Ste 6A, Boston, MA 02215 (rmoeller@bidmc.harvard.edu).

Despite the concerted efforts of modern medicine, infections due to gram-positive bacteria, such as skin and soft tissue infections, pneumonia, bacteremia, and endocarditis, continue to pose many challenges to achieving successful treatment outcomes. A good case in point is found in the emergence and spread of methicillin resistance in Staphylococcus aureus. The first strains of methicillin-resistant S. aureus (MRSA) were discovered a half-century ago in a hospital in London, just 2 years after the first clinical use of methicillin …

PDF

http://cid.oxfordjournals.org/content/58/suppl_1/S1.full.pdf+html

January 30, 2014 at 8:53 pm


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