Jeremy DayDarma ImranAhmed Rizal GaniemNatriana TjahjaniRetno WahyuningsihRobiatul AdawiyahDavid DanceMayfong MayxayPaul NewtonRattanaphone PhetsouvanhSayaphet RattanavongAdrienne K. ChanRobert HeydermanJoep J. van OosterhoutWirongrong ChierakulNick DayAnatoli KamaliFreddie KibengoEugene RuzagiraAlastair GrayDavid G. LallooJustin BeardsleyTran Quang BinhTran Thi Hong ChauNguyen Van Vinh ChauNgo Thi Kim CucJeremy FarrarTran Tinh HienNguyen Van KinhLaura MersonLan PhuongLoc Truong ThoPham Thanh ThuyGuy ThwaitesHeiman WertheimMarcel WolbersOxford University Clinical Research UnitCipto Mangunkusum HospitalHasan Sadikin HospitalRSKO Drug Dependence HospitalLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)University of Malawi College of MedicineMahidol UniversityMRC/UVRI Uganda Research Unit on AIDSUniversity of OxfordWellcome TrustUCLNational Hospital for Tropical DiseasesBach Mai HospitalCho Ray HospitalOxford University Clinical Research UnitIndonesia Christian UniversityUniversitas IndonesiaDignitas International2018-11-092018-11-092014-11-12Trials. Vol.15, No.1 (2014)174562152-s2.0-84928815239https://repository.li.mahidol.ac.th/handle/20.500.14594/34165© 2014 Day et al. Background: Cryptococcal meningitis (CM) is a severe AIDS-defining illness with 90-day case mortality as high as 70% in sub-Saharan Africa, despite treatment. It is the leading cause of death in HIV patients in Asia and Africa. Method: A double-blind placebo-controlled trial with parallel arms in which patients are randomised to receive either dexamethasone or placebo, in addition to local standard of care. The study recruits patients in both Asia and Africa to ensure the relevance of its results to the populations in which the disease burden is highest. The 10-week mortality risk in the control group is expected to be between 30% and 50%, depending on location, and the target hazard ratio of 0.7 corresponds to absolute risk reductions in mortality from 30% to 22%, or from 50% to 38%. Assuming an overall 10-week mortality of at least 30% in our study population, recruitment of 824 patients will be sufficient to observe the expected number of deaths. Allowing for some loss to follow-up, the total sample size for this study is 880 patients. To generate robust evidence across both continents, we aim to recruit roughly similar numbers of patients from each continent. The primary end point is 10-week mortality. Ethical approval has been obtained from Oxford University's Tropical Research Ethics Committee (OxTREC), and as locally mandated at each site. Trial registration: International Standard Randomised Controlled Trial Number: ISRCTN59144167 26-July-2012.Mahidol UniversityMedicineArticleSCOPUS10.1186/1745-6215-15-441