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Could a 6-Month drug cocktail beat 9 months for brain TB?

NCT ID NCT05383742

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a 6-month treatment using high doses of four antibiotics against the standard 9-month therapy for tuberculous meningitis, a serious brain infection. About 330 adults and teens without HIV will take part. The goal is to see if the shorter regimen is as safe and effective at reducing disability or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 sterilization, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, documentation of a serum or urine pregnancy test result (positive or negative; see protocol for test sensitivity requirement) within 21 days prior to study entry * 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 must agree to use at least one acceptable form of contraception, or abstain from sexual activity that could lead to pregnancy while receiving study treatment and for 30 days after stopping study treatment. Participants who are not of reproductive potential or whose partner(s) has documented azoospermia are not required to use contraception. Any statement of self-reported sterility or that of the partner's must be entered in the source documents * 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 Exclusion Criteria: * 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 ankle jerks * 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 study drugs (See protocol) * 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 raltegravir or dolutegravir with nucleoside reverse transcriptase inhibitors, as per local SOC) prior to randomization. TB treatment, including study drugs, should be started as soon as possible * 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 other than Mtb (e.g., cryptococcal meningitis, bacterial meningitis).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barranco CRS (Site ID:11301)

    NOT_YET_RECRUITING

    Lima, 4, Peru

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

    RECRUITING

    Pune, 411001, India

  • Chiangrai Prachanukroh Hospital NICHD CRS (Site ID: 5116)

    RECRUITING

    Chiang Mai, 50100, Thailand

  • Durban International CRS (Site ID:11201)

    NOT_YET_RECRUITING

    Durban, 4091, South Africa

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

    RECRUITING

    Porto Alegre, 91350-200, Brazil

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

    RECRUITING

    Rio de Janeiro, Brazil

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

    RECRUITING

    Kericho, Kenya

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

    NOT_YET_RECRUITING

    Moshi, Tanzania

  • Malawi CRS (Site ID: 12001)

    RECRUITING

    Lilongwe, Malawi

  • Milton Park CRS (Site ID: 30313)

    RECRUITING

    Harare, Zimbabwe

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

    RECRUITING

    Eldoret, 30100, Kenya

  • National Lung Hospital CRS (Site ID: 32483)

    RECRUITING

    Vĩnh Phúc, Hanoi, 100000, Vietnam

  • Nutrición-Mexico CRS (Site ID: 32078)

    NOT_YET_RECRUITING

    Mexico City, 14080, Mexico

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

    NOT_YET_RECRUITING

    Bangkok, Bangkoknoi, 10700, Thailand

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

    NOT_YET_RECRUITING

    Lima, 15046, Peru

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

    NOT_YET_RECRUITING

    Cavite, 4114, Philippines

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

    NOT_YET_RECRUITING

    Bangkok, Pathumwan, 10330, Thailand

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

    NOT_YET_RECRUITING

    Johannesburg, 2193, South Africa

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