RecruitingPhase 2NCT05383742

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

A Phase II, Randomized, Open-Label 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: Improved Management With Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE-TBM)

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

330 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Tuberculous Meningitis

Summary

The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Isoniazid, a drug called Isoniazid (INH), and others for people with tuberculous meningitis. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 15 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRifampicin (RIF)

Rifampicin 35 mg/kg

DRUGIsoniazid (INH)

Isoniazid 10 or15 mg/kg

DRUGLinezolid (LZD)

1200 mg

DRUGPyrazinamide (PZA)

25 mg/kg

DRUGethambutol (EMB)

20 mg/kg

DRUGRifampicin

10 mg/kg

DRUGIsoniazid

5 mg/kg

Locations(18)

Hospital Nossa Senhora da Conceicao CRS (Site ID: 12201)

Porto Alegre, Brazil

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101)

Rio de Janeiro, Brazil

Byramjee Jeejeebhoy Government Medical College (BJMC) CRS (Site ID: 31441)

Pune, India

Moi University Clinical Research Center (MUCRC) CRS (Site ID: 12601)

Eldoret, Kenya

Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site ID: 12501)

Kericho, Kenya

Malawi CRS (Site ID: 12001)

Lilongwe, Malawi

Nutrición-Mexico CRS (Site ID: 32078)

Mexico City, Mexico

Socios en Salud Sucursal Peru CRS (Site ID: 31985)

Lima, Peru

Barranco CRS (Site ID:11301)

Lima, Peru

TB HIV Innovations and Clinical Research Foundation Corp (Site ID: 31981)

Cavite, Philippines

Durban International CRS (Site ID:11201)

Durban, South Africa

University of the Witwatersrand Helen Joseph (WITS HJH) CRS (Site ID: 11101)

Johannesburg, South Africa

Kilimanjaro Christian Medical Centre (KCMC) (Site ID: 5118)

Moshi, Tanzania

Siriraj Hospital, Mahidol University NICHD CRS (Site ID: 5115)

Bangkok, Bangkoknoi, Thailand

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802)

Bangkok, Pathumwan, Thailand

Chiangrai Prachanukroh Hospital NICHD CRS (Site ID: 5116)

Chiang Mai, Thailand

National Lung Hospital CRS (Site ID: 32483)

Vĩnh Phúc, Hanoi, Vietnam

Milton Park CRS (Site ID: 30313)

Harare, Zimbabwe

View Full Details on ClinicalTrials.gov

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NCT05383742

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