Durata Therapeutics (NASDAQ: DRTX) today announced data from a multicenter, observational study related to the clinical development program of its lead product candidate, dalbavancin. The results demonstrate the reliability of the measurement tools deployed by Durata Therapeutics in its two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.
The data are being presented at the Novel Antimicrobial Agents session of IDWeek in San Diego. IDWeek is the first-ever combined meeting of four prestigious societies: the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
A Study to Assess Skin Lesion Measurement Techniques Related to Acute Bacterial Skin and Skin Structure Infections (Dunne, et al). Poster Number 1624.
The U.S. Food and Drug Administration (FDA) issued Draft Guidance in August 2010 that redefines the primary endpoint to be used in clinical trials to support an indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The endpoint requires documentation of both cessation of spread of any cellulitis (skin infection) 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 (skin redness) associated with these lesions.
In this study, 42 patients meeting criteria for an ABSSSI were enrolled and 39 were evaluated. 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 lesions taken from the transparency grid. Lesions measured by digital camera and transparency were 35% and 31% smaller than the ruler, respectively.