Status:
COMPLETED
A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Conditions:
Tuberculous Meningitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 re...
Detailed Description
The study is a parallel group, double blind, randomised, placebo controlled trial of 60 days treatment with placebo vs. 81mg daily dose vs. 1000mg daily dose aspirin for the treatment of HIV-uninfecte...
Eligibility Criteria
Inclusion
- 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
- 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 of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Key Trial Info
Start Date :
October 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02237365
Start Date
October 17 2014
End Date
December 22 2016
Last Update
March 7 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam