Study history
EVENT
The study was opened to Accrual on February 19, 2010 and the first participant enrolled on April 16, 2010. The first international participant, was enrolled on December 22, 2010. Stage 1 closed to accrual on September 5, 2013. Stage 2 opened to accrual on September 15, 2014 under A5225 Version 3.0 and the first participant enrolled on February 2, 2015.On April 2, 2015, the A5225 team leadership informed the sites of a supply problem with the study-provided FCZ. Due to the limited supply of FCZ that was available for distribution, and in best interest of the study, the A5225 team leadership imposed site-specific screening limits for the sites registered or in the process of registering for Version 3 of the protocol. Additional FCZ became available in June 2015. However, there was not enough FCZ on hand to complete the study and the team reviewed FCZ drug supply and enrollment, with screening limits adjusted on a site by site basis until additional Fluconazole became available. Stage 2 closed to accrual on August 19, 2016.Letter of Amendment (LOA) 1 under Version 3 was released on April 20, 2015. A clarification memo under protocol version 3.0 was released on October 12, 2015 in order to clarify treatment options after week 10 treatment failure to help address progression of symptoms. Letter of Amendment 2 for Version 3 was released on October 7, 2016. The LOA was issued to correct the amount of flucytosine allowable prior to study entry; clarify the importance of exercising care in the review and administration of concomitant medications; and to revise the instructions about the follow-up in the event of an abnormal QTc.The protocol may be accessed at 