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Title: 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
Authors: 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 Gray
David 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
Oxford University Clinical Research Unit
Cipto Mangunkusum Hospital
Hasan Sadikin Hospital
RSKO Drug Dependence Hospital
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
University of Malawi College of Medicine
Mahidol University
MRC/UVRI Uganda Research Unit on AIDS
University of Oxford
Wellcome Trust
National Hospital for Tropical Diseases
Bach Mai Hospital
Cho Ray Hospital
Oxford University Clinical Research Unit
Indonesia Christian University
Universitas Indonesia
Dignitas International
Keywords: Medicine
Issue Date: 12-Nov-2014
Citation: Trials. Vol.15, No.1 (2014)
Abstract: © 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.
ISSN: 17456215
Appears in Collections:Scopus 2011-2015

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