Challenges in anti-infective development in the era of bad bugs, no drugs: A regulatory perspective using the example of bloodstream infection as an indication

Clinical Infectious Diseases

Volumn 50, Issue SUPP.1, 2010, Pages

  Boucher, Helen W ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; DALFOPRISTIN PLUS QUINUPRISTIN; LINEZOLID; TIGECYCLINE;

ANTIBIOTIC RESISTANCE; BACTEREMIA; BLOOD CULTURE; BLOODSTREAM INFECTION; CONFERENCE PAPER; DRUG APPROVAL; ESCHERICHIA COLI; FOOD AND DRUG ADMINISTRATION; HUMAN; KLEBSIELLA; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; NONHUMAN; PRACTICE GUIDELINE; PREDICTIVE VALIDITY; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; RISK BENEFIT ANALYSIS; SEPTICEMIA; SERRATIA; SKIN INFECTION; URINARY TRACT INFECTION; VANCOMYCIN RESISTANT ENTEROCOCCUS;

ANTI-BACTERIAL AGENTS; BACTEREMIA; DRUG APPROVAL; DRUG DESIGN; DRUG LABELING; ENTEROCOCCUS FAECIUM; GRAM-POSITIVE BACTERIAL INFECTIONS; HUMANS; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VANCOMYCIN RESISTANCE;

EID: 75749109772     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/647937     Document Type: Conference Paper

References (34)

1. National Nosocomial Infections Surveillance System. National Nosocomial Infections Surveillance (NNIS) System report: data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control 2004;32:470-485
2. Klevens RM, Edwards JR, Gaynes RP. The impact of antimicrobialresistant, health care-associated infections on mortality in the United States. Clin Infect Dis 2008;47:927-930
3. Boucher HW, Corey GR. Epidemiology of methicillin-resistant Staphylococcus aureus. Clin Infect Dis 2008;46(Suppl 5):S344-9.
4. Chopra I, Schofield C, Everett M, et al. Treatment of health-careassociated infections caused by gram-negative bacteria: a consensus statement. Lancet Infect Dis 2008;8:133-139
5. Spellberg B, Guidos R, Gilbert D, et al. The epidemic of antibioticresistant infections: a call to action for the medical community from the Infectious Diseases Society of America. Clin Infect Dis 2008;46: 155-164 (Pubitemid 351269151)
6. Talbot GH, Bradley J, Edwards JE Jr, Gilbert D, Scheld M, Bartlett JG. Bad bugs need drugs: an update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America. Clin Infect Dis 2006;42:657-668 (Pubitemid 43271379)
7. Boucher HW, Talbot GH, Bradley JS, et al. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis 2009;48:1-12.
8. Rice LB. Federal funding for the study of antimicrobial resistance in nosocomial pathogens: no ESKAPE. J Infect Dis 2008;197:1079-1081
9. US Food and Drug Administration. Guidance for industry: clinical development and labeling of anti-infective drug products. No.2. US Department of Health and Human Services. 1992. Available at: http://www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/guidances/ucm070975.pdf. Accessed 19 January 2009.
10. Sorbello A. Bacteremia and CRBSI as labeled BSI indications: a regulatory history. Vol.2008. Silver Spring, MD: US Food and Drug Administration, Center for Drug Evaluation and Research, 2004.
11. US Food and Drug Administration. Guidance for industry: catheter-related bloodstream infections-developing antimicrobial drugs for treatment. US Department of Health and Human Services, Center for Drug Evaluation and Research. 1999. Available at: http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinfbrmation/guidances/ucm070972.pdf. Accessed 19 January 2009.
12. Toivonen M. How bacteraemia is reviewed by medicines licensing authorities in Europe. Int J Antimicrob Agents 2007;30(Suppl l):S103-7.
13. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 1992;20:864-874
14. Juan-Torres A, Harbarth S. Prevention of primary bacteraemia. Int J Antimicrob Agents 2007;30(Suppl l):S80-7.
15. Soreth J. Bacteremia and endocarditis: products and guidance. Silver Spring, MD: US Food and Drug Administration, 2006.
16. Bryan CS. Clinical implications of positive blood cultures. Clin Microbiol Rev 1989;2:329-353 (Pubitemid 19249265)
17. Eliopoulos GM. Antimicrobial agents for treatment of serious infections caused by resistant Staphylococcus aureus and enterococci. Eur J Clin Microbiol Infect Dis 2005;24:826-831
18. Drees M, Boucher H. New agents for Staphylococcus aureus endocarditis. Curr Opin Infect Dis 2006;19:544-550
19. Noskin GA. Tigecycline: a new glycylcycline for treatment of serious infections. Clin Infect Dis 2005;41(Suppl 5):S303-14.
20. Pankey GA. Tigecycline. J Antimicrob Chemother 2005;56:470-480
21. Spellberg B, Powers JH, Brass EP, Miller LG, Edwards JE Jr. Trends in antimicrobial drug development: implications for the future. Clin Infect Dis 2004;38:1279-1286 (Pubitemid 38608571)
22. US Food and Drug Administration. Antimicrobial resistance and drug development FDA/IDSA/ISAP working group presentations and transcripts April 15-16, 2004. Available at: http://www.fda.gov/drugs/drugsafety/ informationbydrugclass/ucm187253.htm. Accessed 9 November 2009.
23. Infectious Diseases Society of America. Bad bugs, no drugs: as antibiotic discovery stagnates...a public health crisis brews. Alexandria, VA: Infectious Diseases Society of America, 2004. Available at: http://www.idsociety.org/ badbugsnodrugs.html. Accessed 9 November 2009.
24. Fowler VG Jr, Miro JM, Hoen B, et al. Staphylococcus aureus endocarditis: a consequence of medical progress. JAMA 2005;293:3012-3021
25. Chu VH, Crosslin DR, Friedman JY, et al. Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes. Am J Med 2005;118:1416.
26. Klevens RM, Morrison MA, Nadle J, et al. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA 2007;298: 1763-1771
27. Lowy FD. Staphylococcus aureus infections. N Engl J Med 1998;339: 520-532
28. Cosgrove SE, Fowler VG Jr. Management of methicillin-resistant Staphylococcus aureas bacteremia. Clin Infect Dis 2008;46(Suppl 5):S386-93.
29. Weinstein MP, Towns ML, Quartey SM, et al. The clinical significance of positive blood cultures in the 1990s: a prospective comprehensive evaluation of the microbiology, epidemiology, and outcome of bacteremia and fungemia in adults. Clin Infect Dis 1997;24:584-602.
30. Fowler VG Jr, Olsen MK, Corey GR, et al. Clinical identifiers of complicated Staphylococcus aureus bacteremia. Arch Intern Med 2003;163: 2066-2072
31. Libman H, Arbeit RD. Complications associated with Staphylococcus aureus bacteremia. Arch Intern Med 1984;144:541-545
32. Fowler VG Jr, Boucher HW, Corey R, et al. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med 2006;355:653-665
33. US Food and Drug Administration. Daptomycin anti-infective drugs advisory committee transcript. Silver Spring, MD: Food and Drug Administration, 2006. Available at: http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4209T1. pdf'. Accessed 9 November 2009.
34. European Medicines Agency. Cubicin European Public Assessment Report for authorised medicinal products for human use. No. H-C-637. 2007. Available at: http://www.emea.europa.eu/humandocs/Humans/EPAR/cubicin/cubicin.htm. Accessed 19 January 2009.