Intensified Short Course Regimen for TBM in Adults

Summary

Tuberculous meningitis (TBM) is the most lethal form of extra pulmonary tuberculosis. This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors. TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice. High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades. However, evidence from such clinical trials is lacking in TBM and the treatment remains uncertain. There is a significant variation in the choice, dose and duration of drugs between countries, institutions and clinicians. Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin, and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids. Controls will receive standard treatment as per national guidelines for TBM. The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT (Rifampicin, INH, Moxifloxacin and Pyrazinamide) in CSF between the two groups

Conditions

• Tuberculous Meningitis

Interventions

DRUG

High dose rifampicin (25mg/kg)

Given for 2 months

DRUG

Moxifloxacin 400mg

Given for 2 months

DRUG

Aspirin 150 mg

Given for 2 months

DRUG

Isoniazid

Given for 6 months

DRUG

Pyrazinamide

Given for 6 months

DRUG

Steroid

Tapering dose of dexamethasone or prednisolone upto 8 weeks

DRUG

Rifampicin

Standard dose for 4 months after the initial treatment with high dose

DRUG

HRZE

2 months

DRUG

HRE

7-10 months as per TB program guidelines

Sponsors & Collaborators

• All India Institute of Medical Sciences, Jodhpur

  collaborator OTHER_GOV

• Christian Medical College, Vellore, India

  collaborator OTHER

• Jawaharlal Institute of Postgraduate Medical Education & Research

  collaborator OTHER_GOV

• North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences

  collaborator OTHER_GOV

• Madras Medical College

  collaborator OTHER_GOV

• Rural Development Trust Hospital

  collaborator OTHER

• Indian Council of Medical Research

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-31

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• India

Study Locations