Loading clinical trials...

Intensified Short Course Regimen for TBM in Adults | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

Intensified Short Course Regimen for TBM in Adults

Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis : an Open-label Randomized Controlled Trial

NCT05917340•Indian Council of Medical Research

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A patient will be eligible for entry to the trial if ALL of the following conditions are satisfied
•1. Adults (\> 18 years) with or without HIV infection
•2. Possible, probable or definite TBM according to Lancet consensus diagnostic criteria
•3. Willing to give written informed consent
•4. Is willing to have an HIV test.
•5. Residing within 100 km of the study sites
•6. Express willingness to attend the treatment centre for supervised treatment
•7. Express willingness to adhere to the trial procedures and follow-up schedule.
•8. Agrees to use effective barrier contraception during the period of the treatment in case of female participants

Exclusion Criteria

•Patients will not be eligible for the trial if they meet ANY of the following criteria
•1. Known current/previous drug resistance to ATT (Rifampicin, INH, FQ)\*\*
•2. Concurrent or known diagnosis any other meningitis such as bacterial, viral, and fungal.
•3. Currently having an uncontrolled cardiac arrhythmia or ECG abnormalities which are contradiction for the administration of moxifloxacin including prolonged QTc. QTc value define as \>450 ms in males and \>460 ms in females measured in lead II or V5 on a standard 12-lead ECG.
•4. Has clinical icterus or hepatic impairment characterized by serum bilirubin level above the normal laboratory reference range with abnormal liver enzymes, or isolated alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) levels above 5 times the upper limit of the normal laboratory reference range
•5. Previous history of anti-TB treatment, If any, should not exceed one month in the past and not more than 7 days in the preceding one month.
•6. pregnant or lactating women
•7. rapid clinical deterioration or very sick and moribund during the screening process, renal failure, liver disease or any condition (social or medical) that in the opinion of the investigator would make trial participation unreliable or unsafe.
•8. Has a known allergy to any of the drugs proposed to be used in the trial regimen
•* All participants with Rifampicin resistance will be excluded at baseline from the study. Participants with H, FQ and Z resistance identified from MGIT results done at baseline will be referred back to NTEP for appropriate management and their numbers will be compensated.

Locations (1)

ICMR- National Institute for Research in Tuberculosis

Chennai, Tamil Nadu, India

Key Dates

Start Date

March 1, 2024

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2027

Last Updated

December 21, 2023

Enrollment

372

ESTIMATED participants

Conditions

Tuberculous Meningitis

Interventions

High dose rifampicin (25mg/kg)

DRUG

Moxifloxacin 400mg

DRUG

Aspirin 150 mg

DRUG

Isoniazid

DRUG

Pyrazinamide

DRUG

Steroid

DRUG

Rifampicin

DRUG

HRZE

DRUG

HRE

DRUG

Contacts

Dr Leeberk Raja Inbaraj, MBBS MD

CONTACT

044-28369527 leeberk.raja@icmr.gov.in

Dr Bella Devaleenal, MBBS MPH

CONTACT

044-28369538 belladevalleenal.d@icmr.gov.in

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

NCT05590455

Tuberculous MeningitisHIV I Infection

View study

RECRUITINGPHASE2

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

NCT05383742

Tuberculous Meningitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intensified Short Course Regimen for TBM in Adults

Inclusion Criteria

Exclusion Criteria

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

B-PaLMZ for TB Meningitis

Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation