CryptoDex: A randomised, double-blind, placebo-controlled phase III trial of adjunctive dexamethasone in HIV-infected adults with cryptococcal meningitis: Study protocol for a randomised control trial

Jeremy Day, Darma Imran, Ahmed Rizal Ganiem, Natriana Tjahjani, Retno Wahyuningsih, Robiatul Adawiyah, David Dance, Mayfong Mayxay, Paul Newton, Rattanaphone Phetsouvanh, Sayaphet Rattanavong, Adrienne K. Chan, Robert Heyderman, Joep J. van Oosterhout, Wirongrong Chierakul, Nick Day, Anatoli Kamali, Freddie Kibengo, Eugene Ruzagira, Alastair GrayDavid G. Lalloo, Justin Beardsley, Tran Quang Binh, Tran Thi Hong Chau, Nguyen Van Vinh Chau, Ngo Thi Kim Cuc, Jeremy Farrar, Tran Tinh Hien, Nguyen Van Kinh, Laura Merson, Lan Phuong, Loc Truong Tho, Pham Thanh Thuy, Guy Thwaites, Heiman Wertheim, Marcel Wolbers

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15 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number441
JournalTrials
Volume15
Issue number1
DOIs
Publication statusPublished - 12 Nov 2014

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