Methods: Adult patients with ABSSSI were enrolled in a randomized, double-blind trial of DLX vs. VAN with aztreonam. Measurements of lesion size were performed at baseline, at 48-72 hr after start of treatment and at other defined time-points including End of Treatment (EOT). A disposable ruler was used for the MM of the longest length and the perpendicular width of the lesion. DM were performed by digital planimetry of the photographed lesion, which had been contoured by the investigator with a disposable marker. Analysis compared the MM and DM.
Results: 660 patients enrolled in the study. At baseline, the mean lesion size from DM and MM was 306.98 cm2 and 510.70 cm2 respectively. Using all corresponding DM and MM at all timepoints, the two methods correlated well, with correlation coefficient of 0.933. At 48-72h after the initiation of therapy, the DM method and MM showed similar percentages of subjects in which treatment stopped the spread of lesion (94.4% vs. 94.2%, respectively) as well as at least 20% reduction in lesion size (85.7% vs. 87.8%, respectively). At EOT, the DM and MM showed similar percentages of subjects in which treatment resulted in at least 70% reduction in lesion size (86.4% vs. 88.1%, respectively) as well as at least 90% reduction in lesion size (61.3% vs. 64.6%, respectively).
Conclusion: Manual measurements consistently exceeded digital measurements as expected, given manual surface areas were calculated as a rectangle. The two methods correlated well, with comparable assessments of percent change from baseline over time. Either manual or digital measurement methods could serve as the primary source of data on lesion size and response to therapy by showing percent change in lesion size.
Melinta Therapeutics, Inc.:
L. Lawrence, Melinta Therapeutics, Inc.: Employee , Salary
M. Quintas, Melinta Therapeutics, Inc.: Employee , Salary
C. Tseng, H2O Clinical LLC: Consultant , Consulting fee
S. K. Cammarata, Melinta Therapeutics, Inc.: Employee , Salary
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