Intensified Antituberculosis Therapy in Adults with Tuberculous Meningitis
| Autor: | Nguyen Duc Bang, Nguyen Phu Huong Lan, Tran Tinh Hien, Nguyen T. B. Yen, Nguyen Quoc Hien, Nguyen Huy Dung, Nguyen Hoan Phu, Nguyen Thi Ngoc Lan, A Dorothee Heemskerk, Pham Phu Loc, Nguyen Thi Hoang Mai, Tran Thi Hong Chau, Nguyen Van Vinh Chau, Guy E. Thwaites, Laura Merson, Jeremy N. Day, Marcel Wolbers, Jeremy Farrar, Nguyen Ngoc Lan, Le T Phong, Dang T M Ha, Tran Thi Van Thinh, Nguyen Nang Vien, Maxine Caws |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Pediatrics Tuberculosis 030106 microbiology wc_302 Tuberculous meningitis law.invention 03 medical and health sciences 0302 clinical medicine Pharmacotherapy Randomized controlled trial law Levofloxacin wl_200 medicine 030212 general & internal medicine business.industry General Medicine medicine.disease 3. Good health Surgery Regimen Adjunctive treatment wf_360 business Meningitis medicine.drug |
| ISSN: | 0028-4793 |
| Popis: | BACKGROUND: Tuberculous meningitis is often lethal. Early antituberculosis treatment and adjunctive treatment with glucocorticoids improve survival, but nearly one third of patients with the condition still die. We hypothesized that intensified antituberculosis treatment would enhance the killing of intracerebral Mycobacterium tuberculosis organisms and decrease the rate of death among patients. METHODS: We performed a randomized, double-blind, placebo-controlled trial involving human immunodeficiency virus (HIV)–infected adults and HIV-uninfected adults with a clinical diagnosis of tuberculous meningitis who were admitted to one of two Vietnamese hospitals. We compared a standard, 9-month antituberculosis regimen (which included 10 mg of rifampin per kilogram of body weight per day) with an intensified regimen that included higher-dose rifampin (15 mg per kilogram per day) and levofloxacin (20 mg per kilogram per day) for the first 8 weeks of treatment. The primary outcome was death by 9 months after randomization. RESULTS: A total of 817 patients (349 of whom were HIV-infected) were enrolled; 409 were randomly assigned to receive the standard regimen, and 408 were assigned to receive intensified treatment. During the 9 months of follow-up, 113 patients in the intensified-treatment group and 114 patients in the standard-treatment group died (hazard ratio, 0.94; 95% confidence interval, 0.73 to 1.22; P=0.66). There was no evidence of a significant differential effect of intensified treatment in the overall population or in any of the subgroups, with the possible exception of patients infected with isoniazid-resistant M. tuberculosis. There were also no significant differences in secondary outcomes between the treatment groups. The overall number of adverse events leading to treatment interruption did not differ significantly between the treatment groups (64 events in the standard-treatment group and 95 events in the intensified-treatment group, P=0.08). CONCLUSIONS: Intensified antituberculosis treatment was not associated with a higher rate of survival among patients with tuberculous meningitis than standard treatment. (Funded by the Wellcome Trust and the Li Ka Shing Foundation; Current Controlled Trials number, ISRCTN61649292. opens in new tab.) |
| Databáze: | OpenAIRE |
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