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Newsletter Vol. 29 No. 2




APUA poster on African research at the 49th Annual Meeting of the IDSA

EU-U.S. workshop on the need for diagnostics to combat antimicrobial resistance
APUA and Massachusetts Department of Public Health sponsor antibiotic stewardship educational program
FDA workshop on antibacterial drugs for the treatment of acute otitis media (AOM)



APUA poster on African research at the 49th Annual Meeting of the IDSA

The 49th Annual Meeting of the Infectious Disease Society of America (IDSA) and the HIV Medicine Association will be held in Boston, Massachusetts on October 20-23, 2011. APUA will present a poster titled “Antibiotic resistance compromises treatment of pneumonia in Ugandan children,” showcasing Gates Foundation-supported research done by Dr. Susan Foster (APUA Director of Public Policy and Education), Dr. Aníbal Sosa (APUA Director of International Chapter Programs), and Dorothy Ochieng (APUA Project Manager). The project documented the rising occurrence, treatment, and impact of antibiotic resistance in the treatment of acute respiratory infections in Ugandan children under the age of 6. Project findings suggest that antibiotic therapy was often ineffective or absent, contributing to antibiotic resistance levels of almost 80% to the most commonly prescribed antibiotic, cotrimoxazole. The goal of this and other IDSA presentations is to increase awareness of rising levels of antibiotic resistance, and the global need for alternative antibiotics.
 



EU-U.S. workshop on the need for diagnostics to combat antimicrobial resistance

The U.S. and EU members of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) have called for a workshop on “Challenges and Solutions in the Development of New Diagnostic Tests to Combat Antimicrobial Resistance,” to be held in Brussels, Belgium on September 28-29, 2011. The workshop aims to recognize the potential of rapid diagnostic tests to guide and enable faster initiation of narrow-spectrum antimicrobial therapy, and to identify the factors that hinder the development, approval, introduction, and appropriate use of novel antimicrobials and new diagnostic tools.

Dr. Donald Low (Chief of Microbiology, Mount Sinai Hospital, and member of the APUA Scientific Advisory Board) will introduce the keynote session and speak on “Setting the Stage: Significance and Need for Rapid Diagnostic Tests for Invasive Bacterial Infections.” Dr. Rosanna Peeling (Professor and Chair of Diagnostic Research, London School of Hygiene and Tropical Medicine) will follow with “A Review of Candidate Technologies,” and Dr. John Rex (Associate Professor of Medicine, University of Texas) will address “The Importance of Rapid Diagnostics for Advancing Antibacterial Development.”

Four subsequent sessions and panel discussions will focus on 1) technical and scientific challenges in the development of rapid diagnostic tests, 2) regulatory challenges, 3) economic factors, and 4) challenges in the acceptance and adoption of new diagnostic tests. For more information, please contact Dr. Jane Knisely (Program Officer, DHHS/NIH/NIAID) at Jane.Knisely@nih.gov or Rachida Ghalouci (Project Officer, European Commission) at Rachida.Ghalouci@ec.europa.eu.
 



APUA and Massachusetts Department of Public Health sponsor antibiotic stewardship educational program

The Massachusetts Department of Public Health and Massachusetts Coalition for the Prevention of Medical Errors, in association with Tufts Medical Center, UMass Memorial Medical Center, Brigham and Women’s Hospital, and APUA, will sponsor an educational program on “Building Stewardship: A Team Approach” in Shrewsbury, Massachusetts on September 14, 2011 (with pre- and post-session audioconferences to be held in September and November). The program will focus on implementing and optimizing antibiotic stewardship in acute care hospitals, enhancing patient care and safety, and reducing antibiotic resistance and societal cost. Physicians, nurses, pharmacists, microbiologists, administrators in acute care facilities, and other experts will participate in the program as multi-disciplinary teams.

Dr. Kenneth Lawrence (Assistant Professor of Medicine, Tufts University) will speak on “Strategies for Stewardship and Tools for Implementation,” followed by Dr. Kristi Kuper (Cardinal Health Pharmacy Solutions) on “Building a Stewardship Program” and a panel discussion on best practices. Group sessions with experts will focus on problem pathogens, business plans, evaluation and IT metrics, and hospital team planning. Register here or visit the Massachusetts Coalition for the Prevention of Medical Errors website for more information.
 






 



FDA workshop on antibacterial drugs for the treatment of acute otitis media (AOM)

The FDA will sponsor a workshop on “Issues in the Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis Media” in Silver Spring, Maryland on September 7, 2011. The objective of the three-session workshop will be to discuss scientific issues in the design of clinical trials of antibacterial drugs for the treatment of AOM (middle ear infection), including appropriate endpoints, the role and effect of tympanocentesis (drainage of fluid from the middle chamber of the ear), the feasibility and acceptability of superiority trial designs, and available data that might support feasible non-inferiority trial designs.

Session 1 will provide a review of current guidelines for clinical care of AOM, previously conducted clinical trials, FDA draft guidance for industry, and regulatory and ethical considerations. Session 2 will discuss recently conducted placebo-controlled clinical trials of AOM, and Session 3 will discuss clinical endpoints and scientifically supported feasible trial designs.

The workshop will be held in the Crowne Plaza Hotel at 8777 Georgia Avenue in Silver Spring, Maryland. For more information see the notice on the Federal Register.
 




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