1. Adjunctive Dexamethasone in HIV-Associated Cryptococcal Meningitis
- Author
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Beardsley, J., Wolbers, M., Kibengo, F.M., Ggayi, A.B., Kamali, A., Cuc, N.T., Binh, T.Q., Chau, N.V., Farrar, J., Merson, L., Phuong, L., Thwaites, G., Kinh, N. Van, Thuy, P.T., Chierakul, W., Siriboon, S., Thiansukhon, E., Onsanit, S., Supphamongkholchaikul, W., Chan, A.K., Heyderman, R., Mwinjiwa, E., Oosterhout, J.J. van, Imran, D., Basri, H., Mayxay, M., Dance, D., Phimmasone, P., Rattanavong, S., Lalloo, D.G., Day, J.N., and Wertheim, H.F.L.
- Subjects
0301 basic medicine ,medicine.medical_specialty ,business.industry ,030106 microbiology ,Hazard ratio ,General Medicine ,Odds ratio ,medicine.disease ,Placebo ,Tuberculous meningitis ,Article ,Surgery ,03 medical and health sciences ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Internal medicine ,medicine ,Cerebrospinal fluid pressure ,business ,Adverse effect ,Meningitis ,Dexamethasone ,medicine.drug - Abstract
Cryptococcal meningitis associated with human immunodeficiency virus (HIV) infection causes more than 600,000 deaths each year worldwide. Treatment has changed little in 20 years, and there are no imminent new anticryptococcal agents. The use of adjuvant glucocorticoids reduces mortality among patients with other forms of meningitis in some populations, but their use is untested in patients with cryptococcal meningitis.In this double-blind, randomized, placebo-controlled trial, we recruited adult patients with HIV-associated cryptococcal meningitis in Vietnam, Thailand, Indonesia, Laos, Uganda, and Malawi. All the patients received either dexamethasone or placebo for 6 weeks, along with combination antifungal therapy with amphotericin B and fluconazole.The trial was stopped for safety reasons after the enrollment of 451 patients. Mortality was 47% in the dexamethasone group and 41% in the placebo group by 10 weeks (hazard ratio in the dexamethasone group, 1.11; 95% confidence interval [CI], 0.84 to 1.47; P=0.45) and 57% and 49%, respectively, by 6 months (hazard ratio, 1.18; 95% CI, 0.91 to 1.53; P=0.20). The percentage of patients with disability at 10 weeks was higher in the dexamethasone group than in the placebo group, with 13% versus 25% having a prespecified good outcome (odds ratio, 0.42; 95% CI, 0.25 to 0.69; P
- Published
- 2016