Actively Recruiting
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-12-02
330
Participants Needed
18
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of definite, probable, or possible tuberculous meningitis with commitment to full standard anti-TB treatment
- Negative or documented positive HIV-1 infection confirmed by specific tests
- Documentation of disease stage using BMRC TBM grade within 3 days prior to entry
- Laboratory values within 3 days prior: serum creatinine ≤1.8 x ULN, hemoglobin ≥8.0 g/dL for men or ≥7.5 g/dL for women, absolute neutrophil count ≥600/mm3, platelet count ≥60,000/mm3, ALT ≤3 x ULN, total bilirubin ≤2 x ULN
- Negative pregnancy test within 21 days if of reproductive potential and not surgically sterile
- Agreement to use contraception or abstain from pregnancy-risk activities during treatment and 30 days after
- Ability and willingness to provide informed consent or assent
- Ability to comply with study protocol requirements as judged by site investigator
You will not qualify if you...
- More than 14 cumulative days of first-line TB medications within 90 days prior to entry
- Known current or prior drug-resistant TB infection
- Known allergy or hypersensitivity to study drugs or their components
- Grade 3 subjective peripheral neuropathy with vibratory loss or absent ankle jerks if screened
- Planned or recent use of medications with significant interactions with study drugs
- For HIV-positive participants, planned initiation or reinitiation of ART during screening or first 4 weeks of TB therapy
- Contraindication to lumbar puncture by clinician judgment
- Positive test within 21 days prior to entry indicating CNS infection other than TBM (e.g., cryptococcal or bacterial meningitis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Hospital Nossa Senhora da Conceicao CRS (Site ID: 12201)
Porto Alegre, Brazil, 91350-200
Actively Recruiting
2
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101)
Rio de Janeiro, Brazil
Actively Recruiting
3
Byramjee Jeejeebhoy Government Medical College (BJMC) CRS (Site ID: 31441)
Pune, India, 411001
Actively Recruiting
4
Moi University Clinical Research Center (MUCRC) CRS (Site ID: 12601)
Eldoret, Kenya, 30100
Actively Recruiting
5
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site ID: 12501)
Kericho, Kenya
Actively Recruiting
6
Malawi CRS (Site ID: 12001)
Lilongwe, Malawi
Actively Recruiting
7
Nutrición-Mexico CRS (Site ID: 32078)
Mexico City, Mexico, 14080
Not Yet Recruiting
8
Socios en Salud Sucursal Peru CRS (Site ID: 31985)
Lima, Peru, 15046
Not Yet Recruiting
9
Barranco CRS (Site ID:11301)
Lima, Peru, 4
Not Yet Recruiting
10
TB HIV Innovations and Clinical Research Foundation Corp (Site ID: 31981)
Cavite, Philippines, 4114
Not Yet Recruiting
11
Durban International CRS (Site ID:11201)
Durban, South Africa, 4091
Not Yet Recruiting
12
University of the Witwatersrand Helen Joseph (WITS HJH) CRS (Site ID: 11101)
Johannesburg, South Africa, 2193
Not Yet Recruiting
13
Kilimanjaro Christian Medical Centre (KCMC) (Site ID: 5118)
Moshi, Tanzania
Not Yet Recruiting
14
Siriraj Hospital, Mahidol University NICHD CRS (Site ID: 5115)
Bangkok, Bangkoknoi, Thailand, 10700
Not Yet Recruiting
15
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802)
Bangkok, Pathumwan, Thailand, 10330
Not Yet Recruiting
16
Chiangrai Prachanukroh Hospital NICHD CRS (Site ID: 5116)
Chiang Mai, Thailand, 50100
Actively Recruiting
17
National Lung Hospital CRS (Site ID: 32483)
Vĩnh Phúc, Hanoi, Vietnam, 100000
Actively Recruiting
18
Milton Park CRS (Site ID: 30313)
Harare, Zimbabwe
Actively Recruiting
Research Team
A
ACTG Clinicaltrials.gov Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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