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Reference: Heemskerk, AD, Bang, ND, Mai, NTH et al., (2016). Intensified antituberculosis therapy in adults with tuberculous meningitis. New England Journal of Medicine, 374 (2), 124-134.Citable link to this page:


Intensified antituberculosis therapy in adults with tuberculous meningitis

Abstract: BackgroundTuberculous 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 tuberculosisorganisms and decrease the rate of death among patients.MethodsWe 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 levof loxacin (20 mg per kilogram per day) for the first 8 weeks of treatment. The primary outcome was death by 9 months after randomization.ResultsA 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 intensifiedtreatment 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).ConclusionsIntensified antituberculosis treatment was not associated with a higher rate of survival among patients with tuberculous meningitis than standard treatment.

Peer Review status:Peer reviewedPublication status:PublishedVersion:Publisher's version Funder: Wellcome Trust   Funder: Li Ka Shing Foundation   Notes:© 2016 Massachusetts Medical Society. All rights reserved.

Bibliographic Details

Publisher: Massachussetts Medical Society

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Journal: New England Journal of Medicinesee more from them

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Issue Date: 2016-01

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Urn: uuid:e4403a0e-23f0-43b6-84b7-f0248de99843

Source identifier: 598873


Issn: 0028-4793 Item Description

Type: Journal article;

Version: Publisher's versionKeywords: Humans Mycobacterium tuberculosis Tuberculosis, Meningeal AIDS-Related Opportunistic Infections HIV Infections Rifampin Antitubercular Agents Drug Therapy, Combination Proportional Hazards Models Double-Blind Method Drug Resistance, Bacterial Adult Middle Aged Female Male Kaplan-Meier Estimate Levofloxacin Tiny URL: pubs:598873


Autor: Heemskerk, AD - institutionUniversity of Oxford Oxford, MSD, NDM, Experimental Medicine - - - Bang, ND - - - Mai, NTH - - - Chau,



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