1624. A Study to Assess Skin Lesion Measurement Techniques Related to Acute Bacterial Skin and Skin Structure Infections
Session: Poster Abstract Session: Novel Antimicrobial Agents
Saturday, October 20, 2012
Room: SDCC Poster Hall F-H
Posters
  • Poster 1624_IDSA 2012_FINAL.pdf (569.6 kB)
  • Background:

    The US Food and Drug Administration recently issued a Draft Guidance that redefines the primary endpoint to be used in registrational studies to support an indication of acute bacterial Skin and Skin Structure Infections (abSSSI). The endpoint requires documentation of both cessation of spread of any cellulitis associated with the infection as well as resolution of fever. This study was designed to provide evidence of reproducibility of the measurements of the erythema associated with these lesions.

    Methods:

    This was a multicenter, observational study in patients with an abSSSI enrolled sequentially. All measurement/procedures were performed at the baseline visit. At least two, and not more than three, observers measured the erythema associated with the abSSSI by ruler; correlation with other techniques such as digital imaging, planimetric assessment of transparencies and thermal imaging was also performed. The primary endpoint was assessment of the intra-observer and inter-observer variability of the erythema as measured by ruler and determined by the intraclass correlation coefficient (ICC).

    Results:

    42 patients meeting criteria for an abSSSI were enrolled; 39 were evaluated for efficacy. Overall, both the repeated (intra-) observer and between (inter-) observer ruler measurements showed almost perfect reliability with ICC's >0.9 for area, length and width. The percent differences in ruler measurements between different observers were slightly larger than between repeated measurements by the same individual (17.4% vs. 4.1%, respectively). Variability was higher in smaller lesions. There was almost perfect intra-observer reliability (ICC>0.9) comparing the longest and shortest lesion measurements by ruler compared to measurements derived programmatically from a computer-assisted planimetry assessment of lesion taken from the transparency grid. Lesions measured by digital camera and transparency were 35% and 31% smaller than the ruler, respectively.

    Conclusion:

    Measurement of the erythema associated with an abSSSI can be reliably performed using a ruler.

    Michael Dunne, MD, Durata Therapeutics, Inc., Morristown, NJ, Purvi Mehra, MD, Estudy, Chula Vista, CA, Sinikka Green, MD, Estudy, LaMesa, CA, Wade Sears, MD, Estudy, Las Vegas, NV, Robert Cockrell, Novellus Research Sites, Fountain Valley, CA, Paul Manos, DO, Estudy, Oceanside, CA, George Talbot, MD, Talbot Advisors LLC, Saint Davids, PA and Anita Das, PhD, Axistat Inc, San Francisco, CA

    Disclosures:

    M. Dunne, Durata Therapeutics: Employee, Salary

    P. Mehra, Durata Therapeutics: Investigator, Research support

    S. Green, Durata Therapeutics: Investigator, Research support

    W. Sears, Durata Therapeutics: Investigator, Research support

    R. Cockrell, Durata Therapeutics: Investigator, Research support

    P. Manos, Durata Therapeutics: Investigator, Research support

    G. Talbot, Durata Therapeutics: Consultant, Scientific Advisor and Shareholder, Consulting fee and equity

    A. Das, Durata Therapeutics: Consultant, Consulting fee

    Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 17th with the exception of research findings presented at the IDWeek press conferences.