Rigor Reviewed

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Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial.

Name: Adcurare Rigor Record — Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial.
Item: Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial.
Rating: 100
Author: Adcurare

Donovan J, Duc Bang N, Dong HKT, Ho DTN, Nguyen TAT, Nguyen TTH, Lam HBN, Phung VKN, Nguyen TT, Nguyen HHH, Pham KNO, Do DAT, Nguyen TMT, Dang TMH, Nguyen HL, Nguyen VVC, Hoang TH, Tran DD, Phung KL, Ramakrishnan L, Le THN, Nguyen TTT, Wolbers M, Kestelyn E, Geskus RB, Nguyen HP, Thwaites GE

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Adcurare Rigor Review — 4.5★ (Strong), 0 critical, 0 high issues for “Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

4.5 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★

Model-reported confidence: HighReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced1 type

Summary statistic impossible for the stated N (GRIM/GRIMMER)

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 5 tests: 5 consistent, 0 inconsistent, 5 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (GRIM/GRIMMER).

Reporting

Eight Dimensions8 pass

The introduction extensively cites prior research on LTA4H genotype associations with inflammatory phenotypes and dexamethasone responsiveness in tuberculous meningitis, including the 2004 trial and subsequent genetic analyses. The rationale linking LTA4H genotype to potential differential corticosteroid response is clearly articulated. The paper acknowledges limitations of prior post-hoc analyses and observational studies, stating they 'may have over-estimated the effects of LTA4H on pathophysiology and treatment outcomes.'

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a strong scientific premise by citing prior work on LTA4H genotype and corticosteroid response, providing a logical rationale for the trial, and addressing limitations of previous studies.

Evidence

direct quote[Introduction, paragraphs 3-5]

“Genetic analysis of a subset of the Vietnam dexamethasone trial participants and subsequent tuberculous meningitis cohorts found that LTA4H genotypes were associated with distinct intracerebral inflammatory phenotypes and dexamethasone responsiveness in HIV-negative individuals”

direct quote[Introduction, paragraph 5]

“We therefore conducted a LTA4H-genotype stratified randomized placebo-controlled trial of dexamethasone in HIV-negative Vietnamese adults with tuberculous meningitis.”

direct quote[Discussion, paragraph 4]

“It may reflect the limitations of previous post-hoc analysis of trials and observational studies, which may have over-estimated the effects of LTA4H on pathophysiology and treatment outcomes.”

PASSReviewer 2· 95% conf

The study clearly establishes its scientific foundation by citing prior work on LTA4H genotype and corticosteroid response, providing a logical rationale for the trial, and acknowledging limitations of previous research.

Evidence

direct quote[Main, paragraph 4]

direct quote[Main, paragraph 5]

“We therefore adopted a hybrid trial-design approach that aimed to prove noninferiority of placebo first in the CC- and CT-genotype population, but also, superiority of placebo should dexamethasone prove harmful.”

direct quote[Discussion, paragraph 5]

“It may reflect the limitations of previous post-hoc analysis of trials and observational studies, which may have over-estimated the effects of LTA4H on pathophysiology and treatment outcomes.”

PASSReviewer 3· 95% conf

The scientific premise is well established with extensive citations of prior research and a clear rationale linking LTA4H genotype to corticosteroid response.

Evidence

direct quote[Introduction, paragraph 3]

direct quote[Discussion, paragraph 3]

“It may reflect the limitations of previous post-hoc analysis of trials and observational studies, which may have over-estimated the effects of LTA4H on pathophysiology and treatment outcomes.”

direct quote[Introduction, paragraph 5]

“Our trial's primary objective was to determine whether placebo is not worse or noninferior than dexamethasone in HIV-negative, CC- and CT-genotype adult patients when added to the first 6–8 weeks of antituberculosis treatment of tuberculous meningitis.”

Randomization was computer-generated with random permuted blocks (size 4 and 6), stratified by hospital, LTA4H genotype, and MRC severity grade. The randomization unit is the individual participant. The trial is double-blind for CC/CT genotypes (placebo-controlled), and TT genotype received open-label dexamethasone with ethical justification. A power analysis is reported: 184 events needed for 80% power at one-sided 2% significance, assuming HR 1.15. Inclusion/exclusion criteria are detailed in the Methods. Outlier handling is described for proteomic/transcriptomic data (e.g., exclusion if >3 SD from first PC). Controls are appropriate (placebo). Independent replication is not applicable for a single pivotal trial, but a planned individual participant meta-analysis with the 2004 trial is included.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous with adequate randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria. Applicable sub-criteria are well-reported.

Evidence

direct quote[Methods, Randomization and study groups]

“The randomization list was computer-generated based on random permuted blocks with block size 4 and 6 (probability 0.75 and 0.25).”

direct quote[Methods, Randomization and study groups]

“LTA4H CC- and CT-genotype participants were randomized to two parallel groups in a 1:1 ratio: dexamethasone or placebo for 6–8 weeks. TT-genotype participants received open-label dexamethasone for 6–8 weeks.”

direct quote[Methods, Statistical analyses]

“To obtain 80% power at the one-sided 2% significance level, 184 events in the CC- and CT-genotype population would be required.”

PASSReviewer 2· 85% conf

The study design is rigorous with reported randomization, power analysis, and inclusion/exclusion criteria, but blinding procedures are not explicitly described.

Evidence

direct quote[Methods, Randomization and study groups]

“The randomization list was computer-generated based on random permuted blocks with block size 4 and 6 (probability 0.75 and 0.25).”

direct quote[Methods, Statistical analyses]

“To obtain 80% power at the one-sided 2% significance level, 184 events in the CC- and CT-genotype population would be required.”

absence[Methods, Randomization and study groups]

Blinding procedures are not described for the randomized groups.

PASSReviewer 3· 95% conf

The study design is rigorous with a well-described randomization method, stratification, and pre-specified analyses, though blinding is absent for TT-genotype participants (by design) and some subjective components are not described.

Evidence

direct quote[Methods, 'Randomization and study groups']

“The randomization list was computer-generated based on random permuted blocks with block size 4 and 6 (probability 0.75 and 0.25).”

direct quote[Methods, 'Statistical analyses']

“To obtain 80% power at the one-sided 2% significance level, 184 events in the CC- and CT-genotype population would be required.”

paraphrase[Methods]

“TT participants received open-label dexamethasone, but no details are given on whether outcome assessors, monitoring committee, or analysts were blinded for these participants.”

Sex is reported (62% male overall) and balanced across arms. Age is reported as median (IQR). Demographics include age, sex, and disease severity (MRC grade). Health status is described via baseline characteristics (e.g., Glasgow coma score, CSF parameters). Species/strain/source and housing conditions are not applicable for a human trial. Sex justification is not applicable as both sexes are enrolled.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables are well-reported for this human clinical trial, including sex, age, and demographics. Species/strain and housing are not applicable.

Evidence

direct quote[Table 1]

“Male sex: 435 (62.0%)”

direct quote[Table 1]

“Age (years): 47 (33–59)”

direct quote[Table 1]

“Modified MRC severity grade: Grade I 298 (42.5%), Grade II 342 (48.7%), Grade III 62 (8.8%)”

PASSReviewer 2· 85% conf

Sex, age, and health status are reported, but weight is not reported, and demographics are limited to Vietnamese adults.

Evidence

direct quote[Table 1]

“Male sex: 435 (62.0%)”

paraphrase[Table 1, Results]

“Age (median 47 years) and MRC severity grade are reported, but no weight data are presented.”

direct quote[Methods, Settings and study population]

“We recruited participants from the Hospital for Tropical Diseases and Pham Ngoc Thach Hospital for Tuberculosis and Lung Disease, in Ho Chi Minh City, Vietnam.”

PASSReviewer 3· 95% conf

Demographics, age, sex, and disease severity are comprehensively reported for the human population, and LTA4H genotyping is detailed. Species/strain/housing are not applicable.

Evidence

direct quote[Table 1]

“Age (years): 47 (33–59); Male sex: 435 (62.0%)”

direct quote[Results, paragraph 2]

“Disease was mostly mild or moderate (640/702 (91.2%), modified Medical Research Council (MRC) severity grade I or II)”

direct quote[Table 1 and Supplementary Tables]

“CSF parameters / Total leucocytes (cells per cubic millimeter): 136 (33–326)”

Informed consent is described: written informed consent was obtained from all participants or a relative if the participant was incapacitated; if capacity returned, consent from the participant was subsequently obtained. The paper provides a list of named ethics committees with approval numbers: Oxford Tropical Research Ethics Committee (52-16), Hospital for Tropical Diseases (37/HDDD), Pham Ngoc Thach Hospital (1034/HDDD-PNT), and Vietnam Ministry of Health (151/CN-BDGDD). Regulatory compliance with local and international standards is implied by the approval from the named bodies.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are well-documented with named ethics committees and protocol numbers, informed consent is described, and regulatory compliance is stated.

Evidence

direct quote[Methods, Ethics and inclusion statement]

“The Oxford Tropical Research Ethics Committee (approval no. 52-16), The Ethical Committee of the Hospital for Tropical Diseases (approval no. 37/HDDD), The Ethical Committee of Pham Ngoc Thach Hospital for Tuberculosis and Lung Disease (approval no. 1034/HDDD-PNT) and The Vietnam Ministry of Health (approval no. 151/CN-BDGDD).”

direct quote[Methods, Study oversight]

“Written informed consent to enter the trial was obtained from all participants or a relative if they were incapacitated. If capacity returned, consent from the participant was obtained.”

direct quote[Methods, Study oversight]

“Trial approvals were obtained from local and national ethics and regulatory authorities in Vietnam, and the Oxford Tropical Research Ethics Committee in the UK.”

WARNReviewer 2· 90% conf

Ethics committee approvals and informed consent are reported, but regulatory compliance with a named framework (e.g., Declaration of Helsinki) is not stated.

Evidence

direct quote[Methods, Ethics and inclusion statement]

direct quote[Methods, Study oversight]

“Written informed consent to enter the trial was obtained from all participants or a relative if they were incapacitated.”

absence[Methods, Ethics and inclusion statement]

No statement of adherence to a named regulatory framework.

PASSReviewer 3· 98% conf

Ethical approvals are reported with named bodies and protocol numbers, and informed consent procedures are described for participants or their relatives.

Evidence

direct quote[Methods, 'Study oversight' and 'Ethics and inclusion statement']

“Ethical approvals were as follows: The Oxford Tropical Research Ethics Committee (approval no. 52-16), The Ethical Committee of the Hospital for Tropical Diseases (approval no. 37/HDDD)...”

direct quote[Methods, 'Study oversight']

“Written informed consent to enter the trial was obtained from all participants or a relative if they were incapacitated. If capacity returned, consent from the participant was obtained.”

Dexamethasone dose, regimen, and route are detailed. The placebo is implied. Software used (R version 4.4.2, STAR, FeatureCounts, etc.) is identified. LTA4H genotyping reagents are also specified. No antibodies, cell lines, or organisms are used, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Key resources are adequately identified for this clinical trial, including the investigational product (dexamethasone), genotyping reagents, and software tools.

Evidence

direct quote[Methods, LTA4H genotyping]

“rs17525495 was genotyped by Taqman using predesigned assay kits (Applied Biosystems) according to the supplier’s instructions”

direct quote[Methods, Statistical analyses]

“The data were analyzed using the program R (version 4.4.2; R Core Team, 2024)”

direct quote[Methods, Study treatments]

“Participants allocated dexamethasone received the 6–8-week regimen previously shown to reduce tuberculous meningitis mortality.”

PASSReviewer 2· 95% conf

The investigational product (dexamethasone) is fully described, and software tools are identified. Other biological resources are not applicable.

Evidence

direct quote[Methods, Study treatments]

“Patients with grade II or III disease received intravenous treatment for four weeks: week 1: 0.4 mg kg−1, week 2: 0.3 mg kg−1, week 3: 0.2 mg kg−1, week 4: 0.1 mg kg−1, then oral treatment for 4 weeks: 4 mg per day, 3 mg per day, 2 mg per day, 1 mg per day.”

direct quote[Methods, Statistical analyses]

“The data were analyzed using the program R (version 4.4.2; R Core Team, 2024)”

direct quote[Methods, LTA4H genotyping]

“rs17525495 was genotyped by Taqman using predesigned assay kits (Applied Biosystems)”

PASSReviewer 3· 95% conf

The investigational product (dexamethasone) is identified, the genotyping reagents are specified, and software tools are reported with versions. Cell lines/antibodies are not used.

Evidence

direct quote[Methods, 'LTA4H genotyping']

“Genomic DNA was extracted from 5 ml of venous blood collected in tubes containing EDTA anti-coagulant using the Nucleon BACC2 Genomic DNA extraction kits (GE Healthcare).”

direct quote[Methods, 'Study treatments']

“Patients with grade II or III disease received intravenous treatment for...”

direct quote[Methods, 'Statistical analyses' and 'Code availability']

“The data were analyzed using the program R (version 4.4.2; R Core Team, 2024)”

The primary analysis uses Cox proportional hazards regression with hazard ratios and CIs. Exact p-values for the primary analysis are reported (p=0.044 for meta-analysis). The proportional hazards assumption was tested and not violated. For the noninferiority analysis, CIs are given. Effect sizes (HRs) and CIs are reported for primary and subgroup analyses. Data presentation uses Kaplan-Meier curves and forest plots, appropriate for a clinical trial. Software is identified (R 4.4.2). Mathematical plausibility checks: The total N of 702 enrolled is the sum of 613 randomized + 89 TT, as stated. The numbers in Table 1 and subgroup tables sum correctly (e.g., 291 CC + 322 CT + 89 TT = 702). The primary outcome counts (108/305 dex vs 110/308 placebo) are plausible given the risks. Per-group n for baseline table is internally consistent. The p-value for the meta-analysis is reported exactly (p=0.044). Exact p-values for some secondary analyses are given as ranges; this is not inadequate for a large trial. Assumptions: normality/equal variance tests are not applicable for Cox models. The pre-specified analysis plan handles assumptions appropriately (Cox model, proportional hazards test).

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical analysis is rigorous with named tests, exact p-values, effect sizes with CIs, and software identified. Assumptions are verified for the primary analysis.

Evidence

direct quote[Results, Primary outcome]

“The proportional-hazards assumption was tested for each model and was not violated (P > 0.05).”

direct quote[Results, Primary outcome]

“hazard ratio of 0.99, 96% confidence interval (adjusted for multiple testing) 0.748–1.31”

direct quote[Methods, Statistical analyses]

“The data were analyzed using the program R (version 4.4.2; R Core Team, 2024)”

PASSReviewer 2· 80% conf

Statistical tests are named, assumptions verified for Cox model, and effect sizes with CIs are reported. However, exact p-values are not reported for the primary outcome, and software is identified.

Evidence

direct quote[Methods, Statistical analyses]

“The primary analysis used a Cox proportional hazards regression model with the primary endpoint as the outcome”

direct quote[Results, Table 2 footnote]

“The proportional-hazards assumption was tested for each model and was not violated (P > 0.05).”

paraphrase[Results, Primary outcome]

“The primary result is reported as hazard ratio 0.99 with 96% CI 0.748–1.31, without a p-value.”

PASSReviewer 3· 93% conf

Statistical methods are appropriate and pre-specified, test assumptions are partially verified, exact p-values and effect sizes are reported for primary analyses, but some multiplicity-adjusted p-values are given as ranges and individual data points are not shown for large-N clinical outcomes.

Evidence

direct quote[Table 2 footnote and Methods]

“The proportional-hazards assumption was tested for each model and was not violated (P > 0.05).”

direct quote[Results, 'Primary outcome' and Figure 3]

“hazard ratio of 0.99, 96% confidence interval (adjusted for multiple testing) 0.748–1.31”

direct quote[Results, 'Planned individual participant meta-analysis']

“hazard ratio of 0.78, 95% CI 0.62–0.99; P = 0.044”

A data availability statement is present: deidentified trial data available on request to OUCRU with a 4-week response timeframe. Proteomic and transcriptomic data are deposited in Dryad (DOI: 10.5061/dryad.f1vhhmh7v). Analysis code is shared on GitHub (oucru-biostats/LAST-ACT). Repository deposit and accession numbers are applicable for the omics data and are adequate. Code sharing is adequate.

Sub-criteria

code sharingADEQUATE

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data and code availability are well-addressed: a data availability statement with a managed access route, proteomic/transcriptomic data deposited in Dryad, and analysis code on GitHub.

Evidence

direct quote[Data availability]

“Deidentified trial participant data (including data dictionaries) will be shared on request to the Oxford University Clinical Research Unit (via emailing the senior author, G.E.T., or corresponding author, J.D.). A response will be provided within 4 weeks of receiving the request.”

direct quote[Data availability]

“Proteomic and transcriptomic data used for this analysis have been deposited into a public repository and are available via Dryad at 10.5061/dryad.f1vhhmh7v”

direct quote[Code availability]

“R analysis code has been made publicly available via GitHub at oucru-biostats/LAST-ACT: Analysis code for LAST ACT trial, https://github.com/oucru-biostats/LAST-ACT”

WARNReviewer 2· 85% conf

Some data are deposited (proteomic/transcriptomic in Dryad), and code is shared on GitHub, but the clinical trial data are only available on request with a vague statement, and no full repository deposit is made for patient-level data.

Evidence

direct quote[Data availability]

“Proteomic and transcriptomic data used for this analysis have been deposited into a public repository and are available via Dryad at 10.5061/dryad.f1vhhmh7v”

direct quote[Code availability]

“R analysis code has been made publicly available via GitHub at oucru-biostats/LAST-ACT: Analysis code for LAST ACT trial, https://github.com/oucru-biostats/LAST-ACT”

PASSReviewer 3· 90% conf

Data availability is stated with a concrete but managed-access pathway, code is shared on GitHub, and sequencing data are deposited in Dryad.

Evidence

direct quote[Data availability]

“Proteomic and transcriptomic data used for this analysis have been deposited into a public repository and are available via Dryad at 10.5061/dryad.f1vhhmh7v”

direct quote[Code availability]

“R analysis code has been made publicly available via GitHub at oucru-biostats/LAST-ACT: Analysis code for LAST ACT trial, https://github.com/oucru-biostats/LAST-ACT .”

Methods are comprehensive, including protocol and statistical analysis plan references. The trial is registered at ClinicalTrials.gov (NCT03100786). A reporting guideline (Nature Portfolio reporting summary) is linked. All pre-specified outcomes are reported, including negative results. Limitations are explicitly discussed (e.g., single-country, LTA4H frequency variation, post-hoc nature of some analyses). Conclusions are proportional, stating that noninferiority was not established and that dexamethasone's benefit is modest. Funding (Wellcome Investigator award 110179/Z/15/Z) and COI are stated.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Reporting is transparent: methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional, and funding/COI are stated.

Evidence

direct quote[Abstract]

“ClinicalTrials.gov NCT03100786”

direct quote[Discussion, paragraph 5]

“Our trial has some limitations. First, it was conducted exclusively in Vietnam.”

direct quote[Acknowledgements]

“The trial was funded by a Wellcome Investigator award (award no. 110179/Z/15/Z to G.E.T.).”

PASSReviewer 2· 85% conf

Methods are complete, trial is registered, all outcomes are reported, limitations are discussed, and conclusions are proportional. However, no explicit reporting guideline is referenced, and a conflicts-of-interest statement is not provided.

Evidence

direct quote[Abstract, Methods]

“ClinicalTrials.gov NCT03100786”

direct quote[Discussion, paragraph 6]

“Our trial has some limitations. First, it was conducted exclusively in Vietnam.”

absence[End of document]

No conflicts-of-interest statement found.

PASSReviewer 3· 93% conf

Reporting is comprehensive with a trial registration, a published protocol, a discussion of limitations, proportional conclusions, and funding/COI statements, though no specific reporting guideline (e.g., CONSORT flow diagram is present but not explicitly labeled as such).

Evidence

direct quote[Abstract and Methods]

“ClinicalTrials.gov NCT03100786”

direct quote[Discussion, paragraph 5]

“First, it was conducted exclusively in Vietnam. LTA4H genotype frequency and effects vary between populations...”

direct quote[Acknowledgements and author contributions]

“The trial was funded by a Wellcome Investigator award (award no. 110179/Z/15/Z to G.E.T.). The funders had no role in study design...”

8 copyedit issues flagged: mostly consistency, clarity, typo.

Checked 39 references: 0 verified — 39 not checked.

Reproducibility

2 data/code links checked; 2 live.

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Full text (79,274 chars · analyzed ~95%, head + tail)Analyzed: Jul 7, 2026

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Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial.

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Journal

DOI

10.1038/s41591-025-04138-z

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