Evidence map›Paper›PMID 29482717›Full record

Trial reporteLife2018

A randomised double blind placebo controlled phase 2 trial of adjunctive aspirin for tuberculous meningitis in HIV-uninfected adults.

Nguyen T H Mai, Nicholas Dobbs, Nguyen Hoan Phu, Romain A Colas, Le T P Thao, Nguyen T T Thuong, Ho D T Nghia, Nguyen H H Hanh, Nguyen T Hang, A Dorothee Heemskerk and 11 more

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in eLife, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02237365 (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), which is not on this map. Cited by 72 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 2 pooled it
17.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02237365 phase2completednot on this map

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

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2014 to 2016Enrolled120ConditionsTuberculous MeningitisArms81mg aspirin, 1000mg aspirin, Placebo
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 2 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Proresolving mediator profiles in cerebrospinal fluid are linked with disease severity and outcome in adults with tuberculous meningitis.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2019
    Trial
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
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  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Host-directed therapy for tuberculosis.European journal of medical research · 2025
    Review
  20. Article

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 4 institutions in 4 countries.

Nguyen T H MaiOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Nicholas DobbsWestern General Hospital, Edinburgh, United Kingdom.
Nguyen Hoan PhuOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Romain A ColasLipid Mediator Unit, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
Le T P ThaoOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Nguyen T T ThuongOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Ho D T NghiaOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Nguyen H H HanhOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Nguyen T HangOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
A Dorothee HeemskerkOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Jeremy N DayOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Lucy LyLipid Mediator Unit, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
Do D A ThuOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Laura MersonCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-4168-1960
Evelyne KestelynOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Marcel WolbersOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Ronald GeskusOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
David SummersWestern General Hospital, Edinburgh, United Kingdom.
Nguyen V V ChauOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Jesmond DalliLipid Mediator Unit, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
Guy E ThwaitesOxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.ORCID http://orcid.org/0000-0002-2858-2087
Oxford University Clinical Research Unit · VNAngkor Hospital for Children · KHQueen Mary University of London · GBWestern General Hospital · GB

Funding

European Research Council 677542Wellcome Trust 089276/E/09/ZWellcome Trust 106680/Z/14/ZWellcome Trust 110179/Z/15/Z
6 · The paper itself

Abstract

Adjunctive dexamethasone reduces mortality from tuberculous meningitis (TBM) but not disability, which is associated with brain infarction. We hypothesised that aspirin prevents TBM-related brain infarction through its anti-thrombotic, anti-inflammatory, and pro-resolution properties. We conducted a randomised controlled trial in HIV-uninfected adults with TBM of daily aspirin 81 mg or 1000 mg, or placebo, added to the first 60 days of anti-tuberculosis drugs and dexamethasone (NCT02237365). The primary safety endpoint was gastro-intestinal or cerebral bleeding by 60 days; the primary efficacy endpoint was new brain infarction confirmed by magnetic resonance imaging or death by 60 days. Secondary endpoints included 8-month survival and neuro-disability; the number of grade 3 and 4 and serious adverse events; and cerebrospinal fluid (CSF) inflammatory lipid mediator profiles. 41 participants were randomised to placebo, 39 to aspirin 81 mg/day, and 40 to aspirin 1000 mg/day between October 2014 and May 2016. TBM was proven microbiologically in 92/120 (76.7%) and baseline brain imaging revealed ≥1 infarct in 40/114 (35.1%) participants. The primary safety outcome occurred in 5/36 (13.9%) given placebo, and in 8/35 (22.9%) and 8/40 (20.0%) given 81 mg and 1000 mg aspirin, respectively (p=0.59). The primary efficacy outcome occurred in 11/38 (28.9%) given placebo, 8/36 (22.2%) given aspirin 81 mg, and 6/38 (15.8%) given 1000 mg aspirin (p=0.40). Planned subgroup analysis showed a significant interaction between aspirin treatment effect and diagnostic category (P

Indexed as

AdultAntitubercular AgentsAspirinCombined Modality TherapyDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleFibrinolytic AgentsHIV InfectionsHumansMaleMental DisordersMiddle AgedPlacebosSurvival AnalysisTreatment OutcomeAntitubercular AgentsAspirinFibrinolytic AgentsPlacebosaspirinclinical trialhumaninfarctioninfectious diseasemicrobiologyMycobacterium tuberculosistuberculous meningitis

Identifiers

PMID29482717
PMCPMC5862527
OpenAlexW2788679213

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.