Which trial do we need? A global, adaptive, platform trial to reduce death and disability from tuberculous meningitis

Thwaites, Guy; Watson, James; Thuong, Nguyen Thuy Thuong; Huynh, Julie; Walker, T. W.; Phu, Nguyen Hoan

doi:10.1016/j.cmi.2023.03.021

Clinical Microbiology and Infection

2023

DOI: 10.1016/j.cmi.2023.03.021

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Which trial do we need? A global, adaptive, platform trial to reduce death and disability from tuberculous meningitis

Guy Thwaites¹,

James Watson²,

Nguyen Thuy Thuong Thuong³

et al.

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Cited by 3 publications

(1 citation statement)

References 19 publications

(14 reference statements)

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“…For example, several trials are investigating the use of high-dose rifampin in both adults and children with TBM [6] , [7] , [8] , [9] , [10] , along with the utility of linezolid [7] , [9] , [10] , [11] and aspirin [7] , [8] , [12] . Even with new information from these trials on the horizon, a more flexible platform to efficiently test novel therapies for TBM has been proposed as a necessary way forward to truly change clinical practice and outcomes [13] , [14] .…”

mentioning

confidence: 99%

A teenage girl with altered mental status and paraparesis

Miyakawa,

Louie,

Keh

et al. 2024

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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mentioning

confidence: 99%

A teenage girl with altered mental status and paraparesis

Miyakawa,

Louie,

Keh

et al. 2024

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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Which trials do we need?

Leibovici

2024

Clinical Microbiology and Infection

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Effectiveness of Adjunctive High-Dose Infliximab Therapy to Improve Disability-Free Survival Among Patients With Severe Central Nervous System Tuberculosis: A Matched Retrospective Cohort Study

Gautam

et al. 2023

Clinical Infectious Diseases

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Background Few treatment options exist for patients with severe central nervous system tuberculosis (CNS TB) worsening due to inflammatory lesions, despite optimal antitubercular therapy (ATT) and steroids. Data regarding the efficacy and safety of infliximab in these patients is sparse. Methods We performed a matched retrospective cohort study based on Medical Research Council (MRC) grading system and modified Rankin Scale (mRS) scores comparing two groups of adults with CNS TB. Cohort-A received at least one dose of infliximab after optimal ATT and steroids, between March, 2019 to July, 2022. Cohort-B received only ATT and steroids. Disability-free survival, [(mRS) score ≤2] at 6-months was the primary outcome. Results Baseline MRC grades and mRS scores were similar between the cohorts. Median duration from the start of ATT and steroids to infliximab treatment was 6 (IQR 3.7-13) months, and neurological deficits was 4 (IQR 2-6.2) months. Indications for infliximab were symptomatic tuberculomas (20/30; 66.7%), spinal cord involvement with paraparesis [8/30; 26.7%] and optochiasmatic arachnoiditis (3/30; 10%), worsening despite adequate ATT and steroids. Severe disability (5/30; 16.7% and 21/60; 35%) and all-cause mortality (2/30; 6.7% and 13/60; 21.7%) at 6-months were lower in Cohort-A. In the combined study population, only exposure to infliximab was positively associated (aRR 6.2, p=0.001, 95% CI 2.18-17.83) with disability-free survival at 6-months. There were no clear infliximab related side effects noted. Conclusion Infliximab may be an effective and safe adjunctive strategy among severely disabled patients with CNS TB, not improving despite optimal ATT and steroids. Adequately powered phase-3 clinical trials are required to confirm these early findings.

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Which trial do we need? A global, adaptive, platform trial to reduce death and disability from tuberculous meningitis

Cited by 3 publications

References 19 publications

A teenage girl with altered mental status and paraparesis

A teenage girl with altered mental status and paraparesis

Which trials do we need?

Effectiveness of Adjunctive High-Dose Infliximab Therapy to Improve Disability-Free Survival Among Patients With Severe Central Nervous System Tuberculosis: A Matched Retrospective Cohort Study

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