[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tuberculous-meningitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tuberculous-meningitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,73,100,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100373655","phase-3-intensified-tuberculosis-treatment-to-reduce-the-mortality-of-patients-with-tuberculous-meningitis-100373655",false,"NCT04145258","Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis","Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis: a Phase III Randomized Controlled Trial (Acronym: INTENSE-TBM)","INTENSE-TBM","Inclusion criteria:\n\n1. Age ≥ 15 years\n2. TBM defined as \"definite\", \"probable\" or \"possible\"\n3. Signed Informed Consent\n\n   * Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test.\n   * Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should come from CSF or cerebral imaging criteria).\n   * Possible TBM = total modified Marais 6-11 when neuroimaging is available, or 6-9 when neuroimaging is not available.\n\nExclusion criteria:\n\n* \\> 5 days of TB treatment\n* Renal failure (eGFR\\\u003C30 ml\u002Fmin, CKD-EPI formula).\n* Neutrophil count \\\u003C 0.6 x 109\u002FL.\n* Hemoglobin concentration \\\u003C 8 g\u002FdL.\n* Total bilirubin \\> 2.6 times the Upper Limit of Normal\n* Platelet count \\\u003C 50 x 109\u002FL.\n* ALT \\> 5 times the Upper Limit of Normal.\n* Clinical evidence of liver failure or decompensated cirrhosis.\n* For women: more than 17 weeks pregnancy or breastfeeding.\n* For patients without decrease level of consciousness (Glasgow Coma Scale = 15): Peripheral neuropathy scoring Grade 3 or above on the Brief Peripheral Neuropathy Score (BPNS).\n* Documented M. tuberculosis resistance to rifampicin.\n* Positive gram-stain, bacterial culture or cryptococcal antigen in the Cerebral Spinal Fluid.\n* Evidence of active bleeding (hemoptysis, gastrointestinal bleeding, hematuria, intracranial bleeding).\n* Inability to collect Cerebral Spinal Fluid, except for patients with confirmed tuberculosis (by rapid molecular test or culture) from another biological sample and clinical and\u002For CT scan evidence of meningitis.\n* Major surgery within the last two weeks prior to inclusion.\n* Ongoing chronic aspirin treatment (eg for cardiovascular risk).\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped (see Appendix 1: Drugs contra-indicated with study drugs).\n* In available history from patients:\n\n  * Evidence of past intracranial bleeding.\n  * Evidence of past of peptic ulceration.\n  * Evidence of recent (\\\u003C 3 month) gastrointestinal bleeding.\n  * Known hypersensitivity contraindicating the use of study drugs .\n  * Evidence of porphyria.\n  * Evidence of hyperuricemia or gout.\n* Any reason which at the discretion of the investigator would compromise safety and cooperation in the trial.","ALL","15 Years",{"count":20,"type":21},768,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa:\n\n* Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment.\n* Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.",[27],"Tuberculous Meningitis",[27,29,30,31,32,33],"Intensified treatment","High dose Rifampicin","Linezolid","Aspirin","Subsaharan Africa","RECRUITING","2026-06-21",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2021-02-07",{"date":42,"type":21},"2026-09-26",{"name":44,"class":45},"ANRS, Emerging Infectious Diseases","OTHER_GOV",13,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100610453","phase-2-b-palmz-for-tb-meningitis-100610453","NCT07227779","B-PaLMZ for TB Meningitis","A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS","Inclusion Criteria:\n\n* First Episode definite or probable TBM with physician intent to treat\n* Age ≥18 years\n* Provision of Informed Consent by participant or surrogate\n* Living with HIV\n* Weight \\> 35kg, estimate or measured\n\nExclusion Criteria:\n\n* Additional active and confirmed CNS infection\n* Known rifampicin-resistant TB\n* Allergy or contraindication to a study medicine\n* More than 5 doses of any TB therapy received within the previous 14 days\n* Presence of jaundice, known liver cirrhosis, elevated ALT or AST \\>3x ULN, or total bilirubin \\>2x ULN\n* Estimated Glomerular Filtration Rate \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \\>450 ms\n* Pregnancy or Breastfeeding\n* Cryptococcal antigen positivity in blood\n* Condition which makes participation not in the participant's best interest","18 Years",{"count":56,"type":21},240,[58],"PHASE2","This two-stage study will compare consented research participants with tuberculous meningitis receiving BPaLMZ to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE.",[27],"NOT_YET_RECRUITING","2026-06-17",{"date":64,"type":38},"2026-06-22",{"date":66,"type":21},"2026-07-20",{"date":68,"type":21},"2030-08-31",{"name":70,"class":71},"University of Minnesota","OTHER",3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100468742","phase-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-100468742","NCT05383742","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","A Phase II, Randomized, Open-Label 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: Improved Management With Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE-TBM)","Inclusion Criteria:\n\n* 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\n* Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, within 30 days prior to study entry, OR\n* HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E\u002FCIA 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\u002For E\u002FCIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \\>1,000 copies\u002FmL are also acceptable as documentation of HIV-1 infection, or documentation of HIV diagnosis in the medical record by a healthcare provider\n* Documentation within 3 days prior to study entry of stage of disease using BMRC TBM grade.\n* The following laboratory values obtained within 3 days prior to study entry:\n\n  * Serum creatinine ≤1.8 times upper limit of normal (ULN)\n  * Hemoglobin ≥8.0 g\u002FdL for men, ≥7.5 g\u002FdL for women\n  * Absolute neutrophil count ≥600\u002Fmm3\n  * Platelet count ≥60,000\u002Fmm3\n  * Alanine aminotransferase (ALT) ≤3 x ULN\n  * Total bilirubin ≤2 x ULN\n* 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\n* Participants with documentation of a positive pregnancy test will be consented using the consent form for pregnant participants.\n\nParticipants 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.\n\nParticipants 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\n\n* Ability and willingness of participant or parent or legally authorized representative (for adolescents or participants unable to provide consent) to provide informed consent\u002Fassent\n* Ability to comply with the protocol requirements in the opinion of the site investigator\n\nExclusion Criteria:\n\n* 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\n* 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)\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation\n* 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\n* 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)\n* 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\n* 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\n* Contraindication to LP at discretion of treating clinician (e.g., unequal pressures between intracranial compartments due to mass lesion, non-communicating hydrocephalus)\n* 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).",{"count":81,"type":21},330,[58],"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).",[27],[86,87,88],"Tuberculosis, meningeal","Tuberculosis","CNS Disease","2026-06-01",{"date":91,"type":38},"2026-06-02",{"date":93,"type":38},"2023-12-07",{"date":95,"type":21},"2029-09-15",{"name":97,"class":98},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",18,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":72},"100484623","phase-2-tnf-inhibitors-to-reduce-mortality-in-hiv-1-infected-patients-with-tuberculosis-meningitis-100484623","NCT05590455","Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis","ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial","TIMPANI","Inclusion Criteria:\n\n* Age ≥18 years\n* HIV-1 infection\n* Definite or probable tuberculosis meningitis\n* Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines\n* Signed informed consent form by patient or relative.\n\nExclusion Criteria:\n\n* Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis\n* Asymptomatic positive cryptococcal antigen in serum\n* HBsAg positive or anti hepatitis C virus antibodies positive\n* Alanine transaminase (ALT)\\>5 ULN\n* Rifampicin-resistant TB detected by GeneXpert MTB\u002FRIF Ultra\n* History of previous TB treatment in patients with GeneXpert MTB\u002FRIF Ultra negative or unavailable\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped\n* Allergy to study drugs or any of their components\n* Uncontrolled opportunistic infection\n* Moderate to severe cardiac insufficiency (NYHA classes III \u002F IV)\n* Any condition which might, in the investigator's opinion, compromise the safety of treatment and\u002For patient's adherence to study procedures\n* For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator\n* Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase\n* Person under guardianship, or deprived of freedom by a judicial or administrative decision",{"count":109,"type":21},130,[58],"Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).",[27,113],"HIV I Infection","2025-12-08",{"date":116,"type":38},"2025-12-15",{"date":118,"type":38},"2023-04-11",{"date":120,"type":21},"2027-12",{"name":44,"class":45},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100509738","phase-3-intensified-short-course-regimen-for-tbm-in-adults-100509738","NCT05917340","Intensified Short Course Regimen for TBM in Adults","Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis : an Open-label Randomized Controlled Trial","INSHORT","Inclusion Criteria:\n\nA patient will be eligible for entry to the trial if ALL of the following conditions are satisfied\n\n1. Adults (\\> 18 years) with or without HIV infection\n2. Possible, probable or definite TBM according to Lancet consensus diagnostic criteria\n3. Willing to give written informed consent\n4. Is willing to have an HIV test.\n5. Residing within 100 km of the study sites\n6. Express willingness to attend the treatment centre for supervised treatment\n7. Express willingness to adhere to the trial procedures and follow-up schedule.\n8. Agrees to use effective barrier contraception during the period of the treatment in case of female participants\n\nExclusion Criteria:\n\nPatients will not be eligible for the trial if they meet ANY of the following criteria\n\n1. Known current\u002Fprevious drug resistance to ATT (Rifampicin, INH, FQ)\\*\\*\n2. Concurrent or known diagnosis any other meningitis such as bacterial, viral, and fungal.\n3. Currently having an uncontrolled cardiac arrhythmia or ECG abnormalities which are contradiction for the administration of moxifloxacin including prolonged QTc. QTc value define as \\>450 ms in males and \\>460 ms in females measured in lead II or V5 on a standard 12-lead ECG.\n4. Has clinical icterus or hepatic impairment characterized by serum bilirubin level above the normal laboratory reference range with abnormal liver enzymes, or isolated alanine aminotransferase (ALT) and\u002F or aspartate aminotransferase (AST) levels above 5 times the upper limit of the normal laboratory reference range\n5. Previous history of anti-TB treatment, If any, should not exceed one month in the past and not more than 7 days in the preceding one month.\n6. pregnant or lactating women\n7. rapid clinical deterioration or very sick and moribund during the screening process, renal failure, liver disease or any condition (social or medical) that in the opinion of the investigator would make trial participation unreliable or unsafe.\n8. Has a known allergy to any of the drugs proposed to be used in the trial regimen\n\n   * All participants with Rifampicin resistance will be excluded at baseline from the study. Participants with H, FQ and Z resistance identified from MGIT results done at baseline will be referred back to NTEP for appropriate management and their numbers will be compensated.",{"count":131,"type":21},372,[24],"Tuberculous meningitis (TBM) is the most lethal form of extra pulmonary tuberculosis. This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors. TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice. High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades. However, evidence from such clinical trials is lacking in TBM and the treatment remains uncertain. There is a significant variation in the choice, dose and duration of drugs between countries, institutions and clinicians. Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin, and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids. Controls will receive standard treatment as per national guidelines for TBM. The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT (Rifampicin, INH, Moxifloxacin and Pyrazinamide) in CSF between the two groups",[27],"2023-12-20",{"date":137,"type":38},"2023-12-21",{"date":139,"type":21},"2024-03",{"date":141,"type":21},"2027-09",{"name":143,"class":45},"Indian Council of Medical Research",1]