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Compares treatment options for Tuberculous Meningitis
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
ClinicalTrials.gov ID: NCT05383742
What this study is testing
What is Rifampicin (RIF)?
Rifampicin (RIF) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tuberculous meningitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- 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...
- 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...
- 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...
- 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:
You likely can't join if
- More than 14 cumulative days of first-line TB medications, including but not limited to INH, RIF, EMB, and PZA, received within 90 days prior to...
- Known current or previous drug resistant TB infection (i.e., resistance to one or more first-line TB medications, including but not limited to INH...
- Known allergy/sensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation
- For participants who are able to undergo the Brief Peripheral Neuropathy Screen (BPNS) within 21 days prior to study entry, Grade 3 subjective...
- Expected concomitant use or use up to 21 days prior to study entry of monoamine oxidase inhibitors or selective serotonin reuptake inhibitors, or...
- For participants with HIV who are ART-naïve or who are not regularly taking ART, planned initiation or reinitiation of ART during screening or during...
See the full eligibility 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...
- 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...
- 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
- For participants of reproductive potential who have not been post-menopausal for at least 24 consecutive months (i.e., no menses within the preceding 24 months), or participants who have not undergone surgical...
- Participants with documentation of a positive pregnancy test will be consented using the consent form for pregnant participants. Participants of reproductive potential with documentation of a negative pregnancy test...
- Ability and willingness of participant or parent or legally authorized representative (for adolescents or participants unable to provide consent) to provide informed consent/assent
- Ability to comply with the protocol requirements in the opinion of the site investigator
- More than 14 cumulative days of first-line TB medications, including but not limited to INH, RIF, EMB, and PZA, received within 90 days prior to study entry
- Known current or previous drug resistant TB infection (i.e., resistance to one or more first-line TB medications, including but not limited to INH, RIF, EMB, LZD and PZA)
- Known allergy/sensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation
- For participants who are able to undergo the Brief Peripheral Neuropathy Screen (BPNS) within 21 days prior to study entry, Grade 3 subjective peripheral neuropathy score on the BPNS AND EITHER vibratory loss OR absent...
- Expected concomitant use or use up to 21 days prior to study entry of monoamine oxidase inhibitors or selective serotonin reuptake inhibitors, or concomitant use of any other drug with significant interaction with the...
- For participants with HIV who are ART-naïve or who are not regularly taking ART, planned initiation or reinitiation of ART during screening or during the first 4 weeks after initiation of TB therapy
- For participants with HIV and on ART that includes a protease inhibitor, nevirapine, or other prohibited ART (see protocol), contraindication to switching to an acceptable alternative regimen (e.g., efavirenz, high-dose...
- Contraindication to LP at discretion of treating clinician (e.g., unequal pressures between intracranial compartments due to mass lesion, non-communicating hydrocephalus)
- Positive cryptococcal antigen, gram stain, bacterial culture, or other test result obtained from a CSF specimen collected within 21 days prior to entry as part of routine care indicating CNS infection with a pathogen...
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Brazil
- Rio de Janeiro, Brazil
- Pune, India
- Eldoret, Kenya
- Kericho, Kenya
- Lilongwe, Malawi
- Mexico City, Mexico
- Lima, Peru
- Cavite, Philippines
- Durban, South Africa
- Johannesburg, South Africa
- Moshi, Tanzania
- Bangkok, Bangkoknoi, Thailand
- Bangkok, Pathumwan, Thailand
- Chiang Mai, Thailand
- Vĩnh Phúc, Hanoi, Vietnam
- Harare, Zimbabwe
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Brazil; Rio de Janeiro, Brazil; Pune, India; Eldoret, Kenya; Kericho, Kenya; Lilongwe, Malawi and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.