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
Condition(s) studied
Investigational drug(s) / intervention(s)
Rifampicin (RIF): Rifampicin 35 mg/kg
Isoniazid (INH): Isoniazid 10 or15 mg/kg
Linezolid (LZD): 1200 mg
Pyrazinamide (PZA): 25 mg/kg
ethambutol (EMB): 20 mg/kg
Rifampicin: 10 mg/kg
Isoniazid: 5 mg/kg
Study 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
Primary outcome measure(s)
- Modified Rankin Scale (6-death, 5-severe disability, 4-moderately severe disability, 3-moderate disability, 2-slight disability, 1-no significant disability, 0-no symptoms) — At 48 weeks
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Nossa Senhora da Conceicao CRS (Site ID: 12201) | Porto Alegre | Brazil | Recruiting |
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101) | Rio de Janeiro | Brazil | Recruiting |
| Byramjee Jeejeebhoy Government Medical College (BJMC) CRS (Site ID: 31441) | Pune | India | Recruiting |
| Moi University Clinical Research Center (MUCRC) CRS (Site ID: 12601) | Eldoret | Kenya | Recruiting |
| Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site ID: 12501) | Kericho | Kenya | Recruiting |
| Malawi CRS (Site ID: 12001) | Lilongwe | Malawi | Recruiting |
| Nutrición-Mexico CRS (Site ID: 32078) | Mexico City | Mexico | Not Yet Recruiting |
| Socios en Salud Sucursal Peru CRS (Site ID: 31985) | Lima | Peru | Not Yet Recruiting |
| Barranco CRS (Site ID:11301) | Lima | Peru | Not Yet Recruiting |
| TB HIV Innovations and Clinical Research Foundation Corp (Site ID: 31981) | Cavite | Philippines | Not Yet Recruiting |
| Durban International CRS (Site ID:11201) | Durban | South Africa | Not Yet Recruiting |
| University of the Witwatersrand Helen Joseph (WITS HJH) CRS (Site ID: 11101) | Johannesburg | South Africa | Not Yet Recruiting |
| Kilimanjaro Christian Medical Centre (KCMC) (Site ID: 5118) | Moshi | Tanzania | Not Yet Recruiting |
| Siriraj Hospital, Mahidol University NICHD CRS (Site ID: 5115) | Bangkok | Bangkoknoi | Not Yet Recruiting |
| Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802) | Bangkok | Pathumwan | Not Yet Recruiting |
| Chiangrai Prachanukroh Hospital NICHD CRS (Site ID: 5116) | Chiang Mai | Thailand | Recruiting |
| National Lung Hospital CRS (Site ID: 32483) | Vĩnh Phúc | Hanoi | Recruiting |
| Milton Park CRS (Site ID: 30313) | Harare | Zimbabwe | Recruiting |
More National Institute of Allergy and Infectious Diseases (NIAID) trials in India
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05383742 on ClinicalTrials.gov ↗ ← All trials in India