(NewsNation) — A new clinical trial seeks participants from countries where tuberculosis is common to test a new drug regimen that treats tuberculous meningitis.
The trial will test a new drug that treats tuberculous meningitis (TBM), comparing a six-month regimen of four drugs as compared to the standard nine-month treatment for TBM. Adults and adolescents are eligible for the study.
TBM occurs when mycobacterium tuberculosis infects the membranes surrounding the brain and spinal cord, called meninges. Mycobacterium tuberculosis typically affects the lungs, causing tuberculosis. When it attacks the meninges, TBM develops, which can cause neurological disabilities and even death. TBM is fatal in 25-50% of adults, with survivors often experiencing permanent disability.
While TB is rare in the U.S., about a quarter of the world’s population has latent TB, where the bacteria remain in the body but are inactive, and roughly 10% of those become ill from infection.
Participants will be either given the new treatment, which lasts six months and uses the drugs rifampicin, isoniazid, linezolid and pyrazinamide, or the standard nine-month treatment using rifampicin, isoniazid, ethambutol and pyrazinamide.
Researchers plan to include 330 subjects who are at least 15 years old and who have or are likely to have TBM based on signs and symptoms. The group will include those living with and without HIV, which increases the risk of dying from TBM. Pregnant women are eligible to enroll.
Researchers note the data from the trial could help improve treatment options for adolescents and pregnant women, where there is limited data on the high doses of rifampicin and linezolid used in treatment and how it affects those populations.