Doxycycline added to standard treatment for central nervous system tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives adults with CNS tuberculosis standard combination anti‑TB therapy and adjunctive corticosteroids, with participants randomized to receive either adjunctive doxycycline or placebo. Enrollment is limited to patients starting TB treatment or within seven days of starting combination therapy. The primary outcome is mortality or severe neurological disability at 8 weeks (modified Rankin score ≥3), while secondary outcomes include measurement of MMPs/TIMPs in plasma and cerebrospinal fluid, functional CSF MMP activity, and whole‑blood and single‑cell RNA transcriptomics. Safety monitoring includes liver function tests and tracking of grade 3–4 and serious adverse events to compare doxycycline plus SOC with placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 21 years and above.
2. Patients receiving ≤ 7 days of TB treatment or about to start combination TB treatment, including injectable agents, where required.
3. Patients with clinical evidence of TB meningitis, as per established diagnostic criteria, defined as either definite, probable or possible CNS-TB:

   1. "Definite" CNS-TB would be defined if acid-fast bacilli (AFB) or a positive nucleic acid amplification test for M. tuberculosis in the cerebrospinal fluid of patients.
   2. "Probable" CNS-TB would be defined if the patient exhibit one or more of the following: suspected pulmonary tuberculosis on chest radiography, acid-fast bacilli found in any specimen other than the cerebrospinal fluid or clinical evidence of other extrapulmonary tuberculosis.
   3. "Possible" CNS-TB would be defined if the patients exhibit at least four of the following: a history of tuberculosis, predominance of lymphocytes in the cerebrospinal fluid, a duration of illness of more than five days, a ratio of cerebrospinal fluid glucose to plasma glucose of less than 0.5, altered consciousness, yellow cerebrospinal fluid, or focal neurologic signs.
4. Alanine aminotransferase (ALT) level \< 3 times the upper limit of normal.
5. Able to provide informed consent. If the patient has no mental capacity to give consent, then consent may be provided for by the patient's next of kin.
6. Lumbar puncture and brain imaging (either computed tomography or magnetic resonance imaging, with or without contrast) is required at baseline for enrolment

Exclusion Criteria:

1. Active Cancer
2. Pregnant or breastfeeding
3. Allergies to tetracyclines
4. Patients on retinoic acid, neuromuscular blocking agents or pimozide which may increase the risk of drug toxicity.
5. Autoimmune disease and/or on systemic immunosuppressants.
6. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of the study drug or planned use during the study period.
7. Enrolment in any other clinical trial involving a systemic drug or intervention involving the CNS.
8. Contraindications to the use of steroids.
9. Investigators' assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol or identification of any factor presumed to significantly increase the participant's risk of suffering an adverse outcome.

Where it's running

• Adam Malik Hospital
  Medan, Medan, Indonesia Recruiting
• Universitas Sumatera Utara
  Medan, Medan, Indonesia Recruiting
• Murni Teguh Memorial Hospital
  Medan, Indonesia Recruiting
• National University Hospital
  Singapore, Singapore, Singapore Recruiting
• Tan Tock Seng Hospital
  Singapore, Singapore Recruiting
• Sarawak General Hospital
  Kuching, Sarawak, Malaysia Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.