Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial

Alvee Saluja; Deepti Vibha; Awadh Kishor Pandit; Garima Shukla; Achal Kumar Srivastava; Manjari Tripathi; Madakasira Vasantha Padma Srivastava; Kameshwar Prasad; Sada Nand Dwivedi

doi:10.3855/jidc.17563

Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial

Authors

Alvee Saluja Department of Neurology, All India Institute of Medical Sciences, New Delhi, India https://orcid.org/0000-0002-8845-2284
Deepti Vibha Department of Neurology, All India Institute of Medical Sciences, New Delhi, India https://orcid.org/0000-0003-3659-7526
Awadh Kishor Pandit Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
Garima Shukla Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
Achal Kumar Srivastava Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
Manjari Tripathi Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
Madakasira Vasantha Padma Srivastava Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
Kameshwar Prasad Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
Sada Nand Dwivedi Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India https://orcid.org/0000-0003-4262-6143

DOI:

https://doi.org/10.3855/jidc.17563

Keywords:

tuberculous meningitis, dexamethasone, corticosteroid, comparison

Abstract

Introduction: Corticosteroids are used as adjunctive treatment in tuberculous meningitis (TBM). However, there is no universally accepted regimen, type, duration, or route of steroid administration.

Methodology: In a randomized open labelled pilot study, TBM patients were divided into overlap oral dexamethasone (OOD) and direct oral dexamethasone (DOD) arms. The total duration of steroid administration was 8 weeks. The primary outcome was symptomatic resolution at 1 month post randomization. The secondary outcomes were mortality and modified Rankin scale (mRS) at 3 and 6 months after initiation of steroids.

Results: Symptomatic resolution after one month of randomization in 53 randomized patients was similar in OOD (71.4% (15/21)) versus DOD ((85.0% (17/20)) arm (p value:0.45). Median mRS was also similar in OOD versus DOD (OOD: 2.5 (IQR: 1.0; 6.0) versus DOD: 1.0 (IQR: (0.0; 4.0); p value: 0.31)) arm at 6 months. The mortality at 6 months was 31.8% (7/22) in the OOD versus 20.0% (4/20) in the DOD arm (p value: 0.49).

Conclusions: In this open label pilot study, the outcomes were similar in OOD versus DOD arms in terms of symptomatic resolution at 1 month, and morbidity, and mortality at 3 and 6 months. Patients with stage I to III TBM may be given injectable steroids for 1 week after which they may be switched to oral steroid. This regime cannot be applied to stage IV TBM and patients with complications like optico-chiasmatic or spinal arachnoiditis or vasculitic infarcts.

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Published

2023-12-31

How to Cite

Saluja A, Vibha D, Pandit AK, Shukla G, Srivastava AK, Tripathi M, Srivastava MVP, Prasad K, Dwivedi SN (2023) Comparison of dexamethasone regimens in tubercular meningitis (TBM): a randomized open label clinical trial. J Infect Dev Ctries 17:1769–1774. doi: 10.3855/jidc.17563

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Issue

Vol. 17 No. 12: December 2023

Section

Original Articles

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