Mycobacterium tuberculosis bacteria, the cause of TB. Credit: NIAID / National Institutes of Health.

The US National Institutes of Health (NIH) has commenced the Phase II IMAGINE-TBM clinical trial of a new drug combination regimen for the treatment of patients with tuberculous meningitis (TBM).

The NIH unit National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the study, designed to evaluate a six-month regimen comprising four drugs versus a nine-month standard-of-care regimen for TBM treatment.

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It is being executed through the NIAID-funded Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) network.

This open-label, randomised trial will enrol 330 adult and adolescent subjects aged 15 years and above from various countries with TB prevalence. 

Subjects in the trial will be given either the investigational six-month regimen comprising high-dose rifampicin and high-dose isoniazid plus linezolid and pyrazinamide or a nine-month standard regimen of rifampicin, isoniazid, ethambutol and pyrazinamide for eight weeks and subsequent treatment with rifampicin and isoniazid.

The trial outcomes will be measured by evaluating the clinical status of the subjects, including neurologic and functional abilities for 48 weeks.

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NIH noted that the treatment options for adolescent children and pregnant women who are at increased risk of poor outcomes following TBM are limited as there exists less data on the usage of high-dose rifampicin and linezolid in these people.

IMAGINE-TBM is anticipated to offer data to expand therapy options for these people.

In a press statement, NIH said: “The study will shed light on a potentially shorter, better treatment for TBM and could result in improved outcomes for patients with this dangerous disease, saving lives and reducing neurological disabilities.”

In October 2023, the NIH announced plans to fund three clinical trials to assess drugs to treat patients with amyotrophic lateral sclerosis (ALS).

The first trial will be led by Prilenia Therapeutics and Massachusetts General Hospital (MGH) researchers assessing pridopidine in 200 ALS patients in the US.

Clene Nanomedicine and Columbia University will evaluate CNM-Au8 in 100 ALS patients. Rapa Therapeutics and MGH researchers will analyse RAPA-501 in 40 ALS patients.