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
|
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Published in |
Trials, November 2014
|
DOI | 10.1186/1745-6215-15-441 |
Pubmed ID | |
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 |
Abstract |
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.No major advance has been made in the treatment of CM since the 1970s. The mainstays of induction therapy are amphotericin B and flucytosine, but these are often poorly available where the disease burden is highest. Adjunctive treatments, such as dexamethasone, have had dramatic effects on mortality in other neurologic infections, but are untested in CM. Given the high death rates in patients receiving current optimal treatment, and the lack of new agents on the horizon, adjuvant treatments, which offer the potential to reduce mortality in CM, should be tested.The principal research question posed by this study is as follows: does adding dexamethasone to standard antifungal therapy for CM reduce mortality? Dexamethasone is a cheap, readily available, and practicable intervention. |
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