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New treatment option for Tuberculosis, Meningeal
Official title Adjunctive Doxycycline for Central Nervous System Tuberculosis
ClinicalTrials.gov ID: NCT06446245
What this study is testing
What is Doxycycline?
Doxycycline is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for tuberculosis, meningeal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Although tuberculosis is now considered a treatable disease, central nervous system tuberculosis (CNS-TB) when managed with the current standard-of-care (SOC), still has mortality rates ranging from 30-50% even in tertiary hospital centers. At present, the SOC for the management of CNS-TB is anti-tuberculous therapy with adjunctive corticosteroids.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Aged 21 years and above.
- Patients receiving ≤ 7 days of TB treatment or about to start combination TB treatment, including injectable agents, where required.
- Patients with clinical evidence of TB meningitis, as per established diagnostic criteria, defined as either definite, probable or possible CNS-TB:
- "Definite" CNS-TB would be defined if acid-fast bacilli (AFB) or a positive nucleic acid amplification test for M. tuberculosis in the cerebrospinal...
- "Probable" CNS-TB would be defined if the patient exhibit one or more of the following: suspected pulmonary tuberculosis on chest radiography...
You likely can't join if
- Active Cancer
- Pregnant or breastfeeding
- Allergies to tetracyclines
- Patients on retinoic acid, neuromuscular blocking agents or pimozide which may increase the risk of drug toxicity.
- Autoimmune disease and/or on systemic immunosuppressants.
- 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...
See the full eligibility criteria
- Aged 21 years and above.
- Patients receiving ≤ 7 days of TB treatment or about to start combination TB treatment, including injectable agents, where required.
- Patients with clinical evidence of TB meningitis, as per established diagnostic criteria, defined as either definite, probable or possible CNS-TB:
- "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.
- "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...
- "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...
- Alanine aminotransferase (ALT) level \< 3 times the upper limit of normal.
- 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.
- Lumbar puncture and brain imaging (either computed tomography or magnetic resonance imaging, with or without contrast) is required at baseline for enrolment
- Active Cancer
- Pregnant or breastfeeding
- Allergies to tetracyclines
- Patients on retinoic acid, neuromuscular blocking agents or pimozide which may increase the risk of drug toxicity.
- Autoimmune disease and/or on systemic immunosuppressants.
- 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.
- Enrolment in any other clinical trial involving a systemic drug or intervention involving the CNS.
- Contraindications to the use of steroids.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Medan, Medan, Indonesia
- Medan, Indonesia
- Kuching, Sarawak, Malaysia
- Singapore, Singapore, Singapore
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Medan, Medan, Indonesia; Medan, Indonesia; Kuching, Sarawak, Malaysia; Singapore, Singapore, Singapore; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.