July 28, 2003
Micrologix and Fujisawa Healthcare reported negative results from a phase III trial investigating MBI 226 for the prevention of central venous catheter-related bloodstream infections. Results showed that the rate of bloodstream infections treated with MBI 226 (2.2%) failed to decrease significantly compared with standard iodine (2.6%). The primary objective of the trial was to demonstrate that MBI 226, administered at central venous catheter insertion sites, was superior to povidone iodine in preventing bloodstream infections. However, MBI 226 did demonstrate statistically significant superiority in preventing catheter colonization, one of the secondary endpoints in the study. Data confirmed a catheter colonization rate of 31% in the MBI 226 group as compared with 40% in the povidone iodine group. The multicenter, randomized study enrolled 1452 subjects. No serious adverse events related to the use of MBI 226 were reported.