폐렴 치료약 개발 번역

폐렴 치료약 개발 번역(영어 원본)

Guidance for Industry
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment
I. INTRODUCTION
The purpose of this guidance is to assist sponsors and investigators in the clinical development of drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator associated bacterial pneumonia (VABP), which are typically caused by methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative Enterobacteriaceae such as Klebsiella pneumoniae, or Gram-negative non-Enterobacteriaceae such as Pseudomonas aeruginosa and Acinetobacter species. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of HABP and VABP.2 This draft guidance is intended to serve as a focus for continued discussions among the Division of Anti-Infective and Ophthalmology Drug Products and the Division of Special Pathogen and Transplant Drug Products, pharmaceutical sponsors, the academic community, and the public. This guidance revises and replaces the draft guidance for industry Nosocomial Pneumonia — Developing Antimicrobial Drugs for Treatment published in 1998. It also supersedes, with regard to the development of drugs to treat HABP/VABP, more general guidance issued many years ago (i.e., Clinical Evaluation of Anti-Infective Drugs (Systemic) and Clinical Development
and Labeling of Anti-Infective Drug Products,4 as well as the joint FDA/Infectious Disease Society of America’s General Guidelines for the Clinical Evaluation of Anti-Infective Drug Products.)5 For the purpose of this guidance, we assume that a majority of hospitalized patients will receive initial treatment with intravenous (IV) antibacterial drugs. However, this does not preclude the enrollment of hospitalized patients in oral drug trials of HABP/VABP. This guidance does not address the development of drugs for other purposes or populations, such as treatment of community-acquired bacterial pneumonia (CABP), viral infections, or atypical bacterial pathogens (e.g., Legionella pneumophila, Mycoplasma pneumoniae, Chlamydophila pneumoniae). This guidance does not address pneumonia that occurs in patients living in chronic health care facilities, because bacterial etiologies may differ from HABP/VABP. This guidance does not address the development of aerosolized antimicrobial drugs. This guidance does not contain discussion of the general issues of clinical trial design or statistical analysis. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials.6 FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. BACKGROUND HABP and VABP by definition occur in hospitalized patients. A hospital stay of 48 hours or more will place patients at risk for colonization and potential infection with a variety of Gram positive and Gram-negative facultative bacteria. Examples of etiologic pathogens of HABP/VABP include Gram-positive bacteria such as MRSA, Gram-negative Enterobacteriaceae such as K. pneumoniae, and Gram-negative non-Enterobacteriaceae such as P. aeruginosa and Acinetobacter species. These bacteria are often resistant to multiple antibacterial drugs, which is an increasing concern. It is also recognized that HABP/VABP may be polymicrobial.
A synonym for HABP and VABP is nosocomial pneumonia. Since the FDA published a draft guidance on the development of antimicrobial drugs for the treatment of nosocomial pneumonia in 1998, there have been public discussions regarding the design of clinical trials to study HABP and VABP, including a workshop on March 31 and April 1, 2009, co-sponsored by the FDA and professional societies.7 These discussions focused on clinical trial designs for HABP and VABP and other important issues such as the following: • Noninferiority versus superiority trial designs • Justification of an appropriate noninferiority margin • Classification of the severity of illness • Enrollment criteria • Application of appropriate diagnostic criteria • Use of appropriate definitions of clinical outcomes • Timing of outcome assessments • Use of prior antimicrobial drugs • Use of concomitant antimicrobial drugs • Differences and similarities between HABP and VABP These discussions and issues have been incorporated into this draft guidance in the appropriate sections below.

폐렴 치료약 개발 번역(한국어 번역본)