Treatment
toxicity
Fluconazole provided by Pfizer, was adjusted for body weight-below 60kg: 20mg/kg for 1200mg, 26mg/kg for 1600mg, and 33mg/kg for 2000mg cohorts. The induction phase of FCZ was continued until the CSF culture was negative or to week 10, whichever was earlier. Amphoterecin B was prescribed between 0ˑ7-1mg/kg/day for 2 weeks. Participants who experienced AMB treatment limiting toxicity prior to day 14 or a total of 8.4 mg/kg AMB either remained in Step-1 and were allowed to receive an alternative treatment, such as liposomal AMB, if available, or entered Step-2 and received study-provided FCZ 800 mg daily or the maximum locally approved daily dose. Participants who failed protocol treatment were transitioned to local standard of care. No participant actually received liposomal AMB. Pharmacokinetic (PK) samples were obtained at specified time points from all participants enrolled in FCZ induction cohorts. Whilst it was permitted across the study, only the USA site had access to flucytosine. None of the participants received flucytosine.The initial FCZ dose was administered as specified, independent of the screening creatinine clearance. Subsequently, FCZ doses were adjusted for clearance rates below 50mL/min, rates between 20-49mL/min, 50% and below 20mL/min 25% of the dose was administered. Participants were followed up for 24 weeks.