Phase 2 Trial of Adding Doxycycline to Standard Treatment and Steroids for Central Nervous System Tuberculosis to Reduce Death and Severe Neurological Problems

What this Trial Is About

Tuberculosis affecting the central nervous system CNS-TB remains a serious condition with high death rates and severe neurological problems despite current standard treatments. Researchers are studying whether adding doxycycline, a drug that may reduce harmful enzymes contributing to tissue damage, to standard anti-tuberculous therapy and corticosteroids can improve survival and reduce brain injury in CNS-TB patients. This is a Phase 2 randomized controlled trial focusing on outcomes at 8 weeks. Participants receive either doxycycline twice daily or a placebo, along with daily standard anti-tuberculosis drugs and corticosteroids tapered over 8 weeks. The anti-tuberculosis regimen includes multiple agents like rifampicin, isoniazid, ethambutol, and possibly others, adjusted for kidney function if needed. After 8 weeks, doxycycline or placebo is stopped, and patients continue their usual TB treatment under their physicians guidance. During the study, participants will have brain imaging and lumbar puncture at baseline and 8 weeks, with lab tests to measure specific enzymes and gene activity related to inflammation. Safety is monitored through liver tests and adverse event tracking. The main outcome is death or severe neurological disability measured by a standardized scale at 8 weeks. The study duration per participant is 8 weeks with close monitoring throughout.

Adjunctive Doxycycline for Central Nervous System Tuberculosis