Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazin… (NCT05383742) | Clinical Trial Compass
RecruitingPhase 2
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
Brazil, India, Kenya330 participantsStarted 2023-12-07
Plain-language 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).
Who can participate
Age range15 Years
SexALL
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Inclusion Criteria:
* Definite, probable, or possible TBM diagnosis wherein the participant is being committed to a full course of SOC anti-TB treatment for TBM in the setting of routine care. CSF, imaging, laboratory, and other results used to determine definite, probable, or possible TBM can be from testing performed as part of routine care, as long as obtained within 21 days prior to study entry
* Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 30 days prior to study entry, OR
* HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection, or documentation of HIV diagnosis in the medical record by a healthcare provider
* Documentation within 3 days prior to study entry of stage of disease using BMRC TBM grade.
* The following laboratory values obtained within 3 days prior to study entry:
* Serum creatinine ≤1.8 times upper limit of normal (ULN)
* Hemoglobin ≥8.0 g/dL for men, ≥7.5 g/dL for women
* Absolute neutrophil count ≥600/mm3
* Platelet count ≥60,000/mm3
* Alanine aminotransferase (ALT) ≤3 x ULN
* Total bilirubin ≤2 x ULN
* …