End points in hospital-acquired pneumonia and/or ventilator-associated pneumonia clinical trials: Food and drug administration perspective

Clinical Infectious Diseases

Volumn 51, Issue SUPPL. 1, 2010, Pages

  Laessig, Katherine A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CEFTAZIDIME; CIPROFLOXACIN; LEVOFLOXACIN; LINEZOLID; PIPERACILLIN PLUS TAZOBACTAM; PLACEBO; ANTIINFECTIVE AGENT;

ANTIMICROBIAL THERAPY; CLINICAL TRIAL; CONFERENCE PAPER; EVALUATION; FOOD AND DRUG ADMINISTRATION; HOSPITAL ACQUIRED PNEUMONIA; HOSPITAL INFECTION; HUMAN; PATIENT ASSESSMENT; PRIORITY JOURNAL; TREATMENT RESPONSE; VENTILATOR ASSOCIATED PNEUMONIA; BIOASSAY; CLINICAL TRIAL (TOPIC); CROSS INFECTION; HOSPITAL; PNEUMONIA, BACTERIAL; PNEUMONIA, VENTILATOR-ASSOCIATED; TREATMENT OUTCOME; UNITED STATES;

ANTI-BACTERIAL AGENTS; CLINICAL TRIALS AS TOPIC; CROSS INFECTION; ENDPOINT DETERMINATION; HOSPITALS; HUMANS; PNEUMONIA, BACTERIAL; PNEUMONIA, VENTILATOR-ASSOCIATED; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77955698627     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/653059     Document Type: Conference Paper

References (8)

1. Centers for Disease Control and Prevention. Guideline for prevention of healthcare-associated pneumonia, 2003. MMWR Morb Mortal Wkly Rep 2004; 53: 1-36.
2. Chastre J, Fagon J-Y. Ventilator-associated pneumonia. Am J Respir Crit Care Med 2002; 165:867-903.
3. Trouillet JL, Chastre J, Vuagnat A, et al. Ventilator-associated pneumonia caused by potentially drug-resistant bacteria. Am J Respir Crit Care Med 1998; 157:531-539.
4. US Food and Drug Administration. Draft guidance for industry: nos-ocomial pneumonia-developing drugs for treatment. Silver Spring, MD: US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, July 1998. http://www.fda.gov/downloads/Drugs/ GuidanceCompliance-RegulatoryInformation/Guidance/ucm071170.pdfAccessed 12 March 2009.
5. Sorbello A, Komo S, Valappil T, et al. Registration trials of antibacterial drugs for the treatment of nosocomial pneumonia. Clin Infect Dis 2010; 51(Suppl 1):S36-S41 (in this supplement).
6. Sorbello A, Komo S, Valappil T. Noninferiority margin for clinical trials of antibacterial drugs for nosocomial pneumonia. Drug Information Journal 2010; 44:165-176.
7. Pugin J, Auckenthaler R, Mili N, et al. Diagnosis of ventilator- associated pneumonia by bacteriologic analysis of bronchoscopic and non-bron-choscopic "blind" bronchoalveolar lavage fluid. Am Rev Respir Dis 1991; 143:1121-1129.
8. Luna CM, Blanzaco D, Niederman MS, et al. Resolution of ventilator associated pneumonia: prospective evaluation of the clinical pulmonary infection score as an early predictor of outcome. Crit Care Med 2003; 31(3):676-682.