A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Men… (NCT02237365) | Clinical Trial Compass
CompletedPhase 2
A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis
Vietnam120 participantsStarted 2014-10-17
Plain-language summary
Tuberculous meningitis is a severe brain infection which often causes disability and death even when treated with the best available treatment. Aspirin is a type of anti-inflammation drug which can reduce the inflammatory response in brains of patients with tuberculous meningitis, and therefore may decrease some of the most severe outcomes. This study compares the use of aspirin (at 2 different doses) versus placebo as an additional therapy to the standard treatment to see if aspirin is safe and helpful in reducing disability and death from tuberculous meningitis. Patients will be treated with aspirin or placebo for 60 days and followed up while on standard treatment for 8 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged 18 years or above.
* Suspected TBM and anti-tuberculosis chemotherapy either planned or started
* Less than 3 days of anti-tuberculosis chemotherapy taken for the current infection
* Patient or representative (if the patient is unable) is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
* HIV infection (negative rapid test or Elisa test is required)
* Unlikely, for any reason, to be able to have an MRI brain scan within 5 days (120 hours) of randomisation
* Known or suspected infection with multi-drug resistant tuberculosis (resistant to at least isoniazid and rifampicin)
* Unable to take isoniazid, rifampicin, or pyrazinamide at recommended doses for any reason
* History of diagnosed peptic ulceration or gastro-intestinal bleeding
* Active gastro-intestinal bleeding is suspected
* Taken \>1 dose of aspirin (at any dose) or any other non-steroidal anti-inflammatory drugs for any reason within 2 weeks of screening
* Aspirin considered mandatory for any reason by the attending physician
* Aspirin considered to be contraindicated for any reason by the attending physician
* Pregnancy or breast feeding (negative urine pregnancy test for all females of child-bearing age)
* Dexamethasone considered to be contraindicated for any reason by the attending physician
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of episodes of either cerebral bleeding or clinically significant upper-gastro-intestinal bleeding (composite endpoint)
Timeframe: 60 days
2
Number of episodes of MRI-proven brain infarction or death (composite endpoint)
Timeframe: 60 days
Trial details
NCT IDNCT02237365
SponsorOxford University Clinical Research Unit, Vietnam