Could a common antibiotic slash deaths from brain TB?
NCT ID NCT06446245
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the antibiotic doxycycline to standard treatment can reduce deaths and severe brain damage in adults with tuberculosis of the brain or its lining. About 200 participants will receive either doxycycline or a placebo for 8 weeks, alongside usual TB drugs and steroids. The study builds on earlier work showing doxycycline may calm harmful inflammation in TB.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxycycline
- What this could lead to
- If it works, this could point toward a cheap, widely available add-on treatment to lower the high death and disability rates from brain tuberculosis.
- What could go wrong
- This is a mid-stage trial with only 200 participants, so results may not apply to everyone. Doxycycline can cause side effects like sun sensitivity and stomach upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Adam Malik Hospital
RECRUITINGMedan, Medan, Indonesia
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Murni Teguh Memorial Hospital
RECRUITINGMedan, Indonesia
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National University Hospital
RECRUITINGSingapore, Singapore, 119228, Singapore
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Sarawak General Hospital
NOT_YET_RECRUITINGKuching, Sarawak, Malaysia
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Tan Tock Seng Hospital
RECRUITINGSingapore, Singapore
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Universitas Sumatera Utara
RECRUITINGMedan, Medan, Indonesia