TY - JOUR
T1 - CryptoDex
T2 - 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
AU - Day, Jeremy
AU - Imran, Darma
AU - Ganiem, Ahmed Rizal
AU - Tjahjani, Natriana
AU - Wahyuningsih, Retno
AU - Adawiyah, Robiatul
AU - Dance, David
AU - Mayxay, Mayfong
AU - Newton, Paul
AU - Phetsouvanh, Rattanaphone
AU - Rattanavong, Sayaphet
AU - Chan, Adrienne K.
AU - Heyderman, Robert
AU - van Oosterhout, Joep J.
AU - Chierakul, Wirongrong
AU - Day, Nick
AU - Kamali, Anatoli
AU - Kibengo, Freddie
AU - Ruzagira, Eugene
AU - Gray, Alastair
AU - Lalloo, David G.
AU - Beardsley, Justin
AU - Binh, Tran Quang
AU - Chau, Tran Thi Hong
AU - Chau, Nguyen Van Vinh
AU - Cuc, Ngo Thi Kim
AU - Farrar, Jeremy
AU - Hien, Tran Tinh
AU - Van Kinh, Nguyen
AU - Merson, Laura
AU - Phuong, Lan
AU - Tho, Loc Truong
AU - Thuy, Pham Thanh
AU - Thwaites, Guy
AU - Wertheim, Heiman
AU - Wolbers, Marcel
N1 - Publisher Copyright:
© 2014 Day et al.
PY - 2014/11/12
Y1 - 2014/11/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84928815239&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-15-441
DO - 10.1186/1745-6215-15-441
M3 - Article
C2 - 25391338
AN - SCOPUS:84928815239
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 441
ER -