[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373655":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":199,"collaborators":201,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":208,"sex":214,"minAge":215,"maxAge":35,"enrollmentInfo":216,"targetDuration":35,"studyType":219,"phases":220,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":81,"whyStopped":35,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"WHO TBM treatment + placebo","OTHER","* Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg\u002Fkg\u002Fd + rifampicin 10 mg\u002Fkg\u002Fd + ethambutol 20 mg\u002Fkg\u002Fd + pyrazinamide 30 mg\u002Fkg\u002Fd + placebo of aspirin\n* W-9 to W-40: isoniazid 5 mg\u002Fkg\u002Fd + rifampicin 10 mg\u002Fkg\u002Fd.",[13,14],"Drug: Placebo of aspirin","Drug: WHO TBM treatment",{"label":16,"type":10,"description":17,"interventionNames":18},"WHO TBM treatment + aspirin","* Inclusion (D-0) to end of Week-8 (W-8): isoniazid 5 mg\u002Fkg\u002Fd + rifampicin 10 mg\u002Fkg\u002Fd + ethambutol 20 mg\u002Fkg\u002Fd + pyrazinamide 30 mg\u002Fkg\u002Fd + aspirin 200 mg\u002Fd\n* W-9 to W-40: isoniazid 5 mg\u002Fkg\u002Fd + rifampicin 10 mg\u002Fkg\u002Fd.",[19,14],"Drug: Aspirin",{"label":21,"type":10,"description":22,"interventionNames":23},"Intensified TBM treatment + placebo","* Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg\u002Fkg\u002Fd) + high dose linezolid (1200 mg\u002Fd from D-0 to end of W-4, then 600 mg\u002Fd from W-5 to W-8) + isoniazid 5 mg\u002Fkg\u002Fd + ethambutol 20 mg\u002Fkg\u002Fd + pyrazinamide 30 mg\u002Fkg\u002Fd + placebo of aspirin\n* W-9 to W-40: isoniazid 5 mg\u002Fkg\u002Fd + rifampicin 10 mg\u002Fkg\u002Fd.",[13,24],"Drug: Intensified TBM treatment",{"label":26,"type":10,"description":27,"interventionNames":28},"Intensified TBM treatment + aspirin","* Inclusion (D-0) to end of Week-8 (W-8): high dose rifampicin (35 mg\u002Fkg\u002Fd) + high dose linezolid (1200 mg\u002Fd from D-0 to end of W-4, then 600 mg\u002Fd from W-5 to W-8) + isoniazid 5 mg\u002Fkg\u002Fd + ethambutol 20 mg\u002Fkg\u002Fd + pyrazinamide 30 mg\u002Fkg\u002Fd + aspirin 200 mg\u002Fd\n* W-9 to W-40: isoniazid 5 mg\u002Fkg\u002Fd + rifampicin 10 mg\u002Fkg\u002Fd.",[19,24],[30,36,40,46],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Aspirin","Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)",[26,16],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Placebo of aspirin","Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)",[21,9],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"WHO TBM treatment","2 months of (R-H-Z-E) + 7 months of (R-H)",[16,9],[45],"Standard WHO treatment for TB meningitis",{"type":31,"name":47,"description":48,"armGroupLabels":49,"otherNames":35},"Intensified TBM treatment","2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid",[26,21],[51],{"name":52,"affiliation":53,"role":54},"Fabrice Bonnet, M.D., Ph.D.","University Hospital, Bordeaux","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":35,"email":59},"CONTACT","+33 (0)5 56 79 58 26","fabrice.bonnet@chu-bordeaux.fr",{"name":61,"role":57,"phone":62,"phoneExt":35,"email":63},"Xavier Anglaret, M.D., Ph.D.","+33 (0)5 57 57 12 58","xavier.anglaret@u-bordeaux.fr",[65,79,88,96,109,120,131,144,151,159,170,178,191],{"facility":66,"status":67,"city":68,"state":35,"zip":35,"country":69,"countryCode":35,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Cocody University Hospital","NOT_YET_RECRUITING","Abidjan","Côte d’Ivoire",{"type":71,"coordinates":72},"Point",[73,74],-4.00167,5.35444,{"lat":74,"lon":73},[77],{"name":78,"role":57,"phone":35,"phoneExt":35,"email":35},"Horo Kigninlman, Prof",{"facility":80,"status":81,"city":68,"state":35,"zip":35,"country":69,"countryCode":35,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Treichville University Hospital","RECRUITING",{"type":71,"coordinates":83},[73,74],{"lat":74,"lon":73},[86],{"name":87,"role":57,"phone":35,"phoneExt":35,"email":35},"Gisèle Kouakou, Prof.",{"facility":89,"status":67,"city":68,"state":35,"zip":35,"country":69,"countryCode":35,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Yopougon University Hospital",{"type":71,"coordinates":91},[73,74],{"lat":74,"lon":73},[94],{"name":95,"role":57,"phone":35,"phoneExt":35,"email":35},"Thierry Odehoury-Koudou, Prof",{"facility":97,"status":81,"city":98,"state":35,"zip":35,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Hospital Joseph Raseta Befelatanana","Antananarivo","Madagascar","MG",{"type":71,"coordinates":102},[103,104],47.53613,-18.91368,{"lat":104,"lon":103},[107],{"name":108,"role":57,"phone":35,"phoneExt":35,"email":35},"Mamy Jean de Dieu Randria, Prof.",{"facility":110,"status":81,"city":111,"state":35,"zip":35,"country":99,"countryCode":100,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University Hospital Tambohobe","Fianarantsoa",{"type":71,"coordinates":113},[114,115],47.08569,-21.45267,{"lat":115,"lon":114},[118],{"name":119,"role":57,"phone":35,"phoneExt":35,"email":35},"Rivonirina Andry Rakotoarivelo, Prof.",{"facility":121,"status":67,"city":122,"state":35,"zip":35,"country":99,"countryCode":100,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Morafeno University Hospital","Toamasina",{"type":71,"coordinates":124},[125,126],49.40234,-18.1492,{"lat":126,"lon":125},[129],{"name":130,"role":57,"phone":35,"phoneExt":35,"email":35},"Stéphane Dimby Ralandison, Prof",{"facility":132,"status":81,"city":133,"state":35,"zip":35,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Kayelitsha District Hospital","Cape Town","South Africa","ZA",{"type":71,"coordinates":137},[138,139],18.42322,-33.92584,{"lat":139,"lon":138},[142],{"name":143,"role":57,"phone":35,"phoneExt":35,"email":35},"Graeme Meintjes, Prof.",{"facility":145,"status":81,"city":133,"state":35,"zip":35,"country":134,"countryCode":135,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"Mitchells Plain 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Hospitals",{"type":71,"coordinates":173},[164,165],{"lat":165,"lon":164},[176],{"name":177,"role":57,"phone":35,"phoneExt":35,"email":35},"John Black, Dr.",{"facility":179,"status":81,"city":180,"state":35,"zip":35,"country":181,"countryCode":182,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Mbarara Regional Reference Hospital","Mbarara","Uganda","UG",{"type":71,"coordinates":184},[185,186],30.64851,-0.60467,{"lat":186,"lon":185},[189],{"name":190,"role":57,"phone":35,"phoneExt":35,"email":35},"Conrad Muzoora, Dr.",{"facility":192,"status":81,"city":180,"state":35,"zip":35,"country":181,"countryCode":182,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"Regional Reference Hospital of Kabale",{"type":71,"coordinates":194},[185,186],{"lat":186,"lon":185},[197],{"name":198,"role":57,"phone":35,"phoneExt":35,"email":35},"Marion Namutebi, Dr.",{"type":200,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[202,204],{"name":203,"class":10},"European Union",{"name":205,"class":6},"European and Developing Countries Clinical Trials Partnership (EDCTP)","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":217,"type":218},768,"ESTIMATED","INTERVENTIONAL",[221],"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.",[224],"Tuberculous Meningitis",[224,226,227,228,32,229],"Intensified treatment","High dose Rifampicin","Linezolid","Subsaharan Africa","2026-06-21",{"date":232,"type":233},"2026-06-24","ACTUAL",{"date":235,"type":233},"2021-02-07",{"date":237,"type":218},"2026-09-26",{"name":5,"class":6},13]