Acute bacterial skin and skin structure infection trials: The bad is the enemy of the good

Clinical Infectious Diseases

Volumn 53, Issue 12, 2011, Pages 1308-1309

  Spellberg, Brad ^a,b  

^a HARBOR UCLA MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA LACTAM; PENICILLIN G; SULFAMIDOCHRYSOIDINE; SULFANILAMIDE;

CELLULITIS; DRUG EFFICACY; HUMAN; LETTER; MORTALITY; PRIORITY JOURNAL; SKIN INFECTION; TREATMENT FAILURE;

CLINICAL TRIALS AS TOPIC; HUMANS; SKIN DISEASES, BACTERIAL;

EID: 81855205236     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cir741     Document Type: Letter

References (5)

1. Corey GR. Stryjewski ME. New rules for clinical trials of patients with acute bacterial skin and skin-structure infections: do not let the perfect be the enemy of the good. Clin Infect Dis 2011; 52(Suppl 7):S469-76.
2. US Food and Drug Administration. Guidance for industry. Acute bacterial skin and skin structure infections: developing drugs for treatment. Tables 2, 3. 2011. Available at: http://www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/ucm071185.pdf. Accessed 5 July 2011.
3. Madsen ST. Scarlet fever and erysipelas in Norway during the last hundred years. Infection 1973; 1:76-81.
4. Spellberg B, Talbot GH, Boucher HW, et al. Antimicrobial agents for complicated skin and skin-structure infections: justification of noninferiority margins in the absence of placebocontrolled trials. Clin Infect Dis 2009; 49: 383-91.
5. Spellberg B. The tribulations of trials for antibacterial drugs: interview with Brad Spellberg. Clin Invest 2011; 1:925-31.