Registration trials of antibacterial drugs for the treatment of nosocomial pneumonia

Clinical Infectious Diseases

Volumn 51, Issue SUPPL. 1, 2010, Pages

  Sorbello, Alfred ^a   Komo, Scott ^a   Valappil, Thamban ^a   Nambiar, Sumati ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

AMIKACIN; ANTIINFECTIVE AGENT; AZTREONAM; CEFTAZIDIME; CILASTATIN PLUS IMIPENEM; CIPROFLOXACIN; GENTAMICIN; PIPERACILLIN PLUS TAZOBACTAM; TOBRAMYCIN; VANCOMYCIN;

ACINETOBACTER; BACTERIAL PNEUMONIA; CLINICAL TRIAL; CONFERENCE PAPER; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; HOSPITAL INFECTION; HUMAN; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; NONHUMAN; PATHOGENESIS; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; REGISTRATION; VENTILATOR ASSOCIATED PNEUMONIA; ADOLESCENT; ADULT; AGED; APACHE; CLINICAL TRIAL (TOPIC); CROSS INFECTION; FEMALE; ISOLATION AND PURIFICATION; MALE; METHODOLOGY; MICROBIOLOGY; MIDDLE AGED; MORTALITY; PATHOLOGY; PNEUMONIA, BACTERIAL; PNEUMONIA, VENTILATOR-ASSOCIATED; STAPHYLOCOCCUS AUREUS; TREATMENT OUTCOME; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ACINETOBACTER; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; APACHE; CLINICAL TRIALS AS TOPIC; CROSS INFECTION; FEMALE; HUMANS; MALE; MIDDLE AGED; PNEUMONIA, BACTERIAL; PNEUMONIA, VENTILATOR-ASSOCIATED; PSEUDOMONAS AERUGINOSA; RESEARCH DESIGN; STAPHYLOCOCCUS AUREUS; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

EID: 77955696252     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/653038     Document Type: Conference Paper

References (15)

1. Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and deaths in US hospitals, 2002. Public Health Rep 2007; 122:160.
2. Ostendorf U, Ewig S, Torres A. Nosocomial pneumonia. Curr Opin Infect Dis 2006; 19:327-338.
3. American Thoracic Society, Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 2005; 171:388-416.
4. Hidron AI, Edwards JR, Patel J, et al. Antimicrobial-resistant pathogens associated with healthcare-associated infections: annual summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2006-2007. Infect Control Hosp Epidemiol 2008; 29:996-1011.
5. Nordmann P, Cuzon G, Naas T. The real threat of Klebsiella pneumoniae carbapenemase-producing bacteria. Lancet Infect Dis 2009; 9:228-236.
6. Munoz-Price LS, Quinn JP. The spread of Klebsiella pneumoniae car-bapenemases: a tale of strains, plasmids, and transposons. Clin Infect Dis 2009; 49:1739-1741.
7. US Food and Drug Administration. Points to consider: clinical development and labeling of anti-infective drug products. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070975.pdf. Accessed 4 November 2009.
8. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985; 13(10): 818-829.
9. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. I. Ethical and scientific issues. Ann Intern Med 2000; 133:455-463.
10. Hung HMJ, Wang SJ, O'Neill R. A regulatory perspective on choice of margin and statistical inference in non-inferiority trials. Biometrical J 2005; 47(1):28-36.
11. Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med 2006; 145:62-69.
12. US Food and Drug Administration. Guidance for industry: E 10 choice of control group and related issues in clinical trials, 2001. http://www.fda.gov/ RegulatoryInformation/Guidances/ucm125802.htm. Accessed 26 October 2009.
13. US Food and Drug Administration (2007). Guidance for industry\ antimicrobial drug products: use of noninferiority studies to support approval (draft guidance). http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070951.pdf. Accessed 26 October 2009.
14. Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in medical intensive care units in the United States. Crit Care Med 1999; 27(5):887-892.
15. McDonald LC. Trends in antimicrobial resistance in health care-associated pathogens and effect on treatment. Clin Infect Dis 2006; 42(suppl 1):S65-S71.