A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02237365
• Date of registration: 09/09/2014
• Prospective Registration: Yes
• Primary sponsor: Oxford University Clinical Research Unit, Vietnam
• Public title: A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis AspirinTBM
• Scientific title: A Pilot Phase II Randomized Controlled Double Blind Trial of 81mg Aspirin Daily vs. 1000 mg Aspirin Daily vs. Placebo as Adjunctive Therapy in HIV Negative Adults With Tuberculous Meningitis
• Date of first enrolment: October 17, 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02237365
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Vietnam

Contacts

• Name: Nguyen H Phu, MD, PhD
• Affiliation: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

• Name: Guy Thwaites, MD, PhD
• Affiliation: Oxford University of Clinical Research

Key inclusion & exclusion criteria

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 of participation in the study, or may
influence the result of the study, or the participant's ability to participate in the
study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculous Meningitis

Intervention(s)

Drug: Placebo

Drug: 1000mg aspirin

Drug: 81mg aspirin

Primary Outcome(s)

Number of episodes of MRI-proven brain infarction or death (composite endpoint) [Time Frame: 60 days]

Number of episodes of either cerebral bleeding or clinically significant upper-gastro-intestinal bleeding (composite endpoint) [Time Frame: 60 days]

Secondary Outcome(s)

Antimicrobial activity of peripheral blood monocyte/macrophages [Time Frame: 240 days]

Resolution of cerebrospinal fluid (CSF) inflammation [Time Frame: 30 days]

Duration of hospital stay [Time Frame: 240 days]

Neurological disability score [Time Frame: 60 days]

Number of grade 3&4 and serious adverse events [Time Frame: 60 days]

Proportion of patients with MRI-proven brain infarction [Time Frame: 240 days]

Neurological disability score [Time Frame: 240 days]

Time to death [Time Frame: 240 days]

Secondary ID(s)

23TB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam