A study published in the New England Journal of Medicine on January 13, 2016, shows that intensifying antituberculosis treatment did not improve the survival rate in patients with tuberculous meningitis. Dorothee Heemskirk, MD of the Oxford University Clinical Research Unit at the Centre for Tropical Medicine in Ho Chi Minh City, Vietnam, and colleagues completed the study.
Nearly half of patients with tuberculous meningitis die from the disease, even with early antituberculosis chemotherapy and treatment with glucocorticoids. This study was undertaken to “test the hypothesis that intensified antituberculosis treatment -- with higher-dose rifampin and the addition of levofloxacin for the first 8 weeks of treatment -- would result in lower rates of death and disability from tuberculous meningitis than the rates with the currently recommended regimen.”
Study participants were recruited from Pham Ngoc Thach Hospital for Tuberculosis and Lung Disease and the Hospital for Tropical Diseases, which are both located in Ho Chi Minh City in Vietnam. There were a total of 817 participants, who were randomly assigned to receive standard treatment plus a placebo, or to receive additional rifampin and levofloxacin. There were 409 in the standard treatment group and 408 in the intensified treatment group, but a total of 53 did not complete follow up.
According to the study design, “the primary outcome was death by 9 months after randomization. The secondary outcomes included neurologic disability at 9 months, time to first new neurologic event or death, and serious adverse events.” A total of 227 patients died during the 9 month follow up period, of those, 113 were in the intensified treatment group, and 114 were in the standard treatment group.
As for secondary outcomes, the researchers found “there was no significant difference between the treatment groups with regard to clinical adverse events, apart from a higher frequency of seizures in the intensified-treatment group.” Patients in the intensified treatment group also had a higher frequency of vision impairment, and signs drug allergy occurred more often in that group.
The researchers concluded, “In this pragmatic, randomized, double-blind, placebo-controlled trial involving adults with tuberculous meningitis, intensified antituberculosis treatment was not associated with a higher rate of survival than the rate with standard treatments.”
Source: MD Magazine