[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610453":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":11,"studyPopulation":11,"armGroups":70,"interventions":81,"overallOfficials":86,"centralContacts":90,"locations":99,"responsibleParty":131,"collaborators":135,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":11,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":11,"enrollmentInfo":156,"targetDuration":11,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":11,"overallStatus":102,"whyStopped":11,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"University of Minnesota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Time to Death",null,"24 Weeks",{"measure":14,"description":15,"timeFrame":12},"Hierarchical composite endpoint (survival + functional status)","Hierarchical composite endpoint of survival and modified Rankin score (0-6 scale) assessed by Win Ratio",[17,21,24,27,30,33,37,41,45,48,51,55,58,61],{"measure":18,"description":19,"timeFrame":20},"Serious adverse events (SAE)","Incidience of Serious adverse events","28 weeks",{"measure":22,"description":23,"timeFrame":20},"Clinical Adverse Events","Clinical Adverse Events, by grade (1-5) associated with TB drug discontinuation, dose reduction, or interruption \\>3 days",{"measure":25,"description":26,"timeFrame":20},"Laboratory abnormalities","Number of participants with grade 3 or 4 abnormal laboratory values, by the Division of AIDS toxicity grading scale",{"measure":28,"description":29,"timeFrame":20},"Neuropathy","Incidence of Neuropathy",{"measure":31,"description":32,"timeFrame":20},"Drug induced liver injury","Drug induced liver injury with Grade \\>=3 with serum alanine aminotransferase (ALT) \\>5x upper limit or normal or total bilirubin \\>2.5x upper limit of normal)",{"measure":34,"description":35,"timeFrame":36},"Change in CSF inflammatory markers","Change in CSF leukocytes from baseline to day 7 and 14 visits.","14 days",{"measure":38,"description":39,"timeFrame":40},"Modified Rankin Scale","Modified Rankin Score as an ordinal score (0-6 scale) of:\n\n0 Alive: no residual symptoms or disability.\n\n1. No significant disability: symptoms are present but do not prevent carrying out all usual duties and activities; able to carry out all pre-TBM activities.\n2. Slight disability: unable to carry out all pre-TBM activities but able to look after self without daily help.\n3. Moderate disability: requires some assistance with tasks but able to walk without assistance.\n4. Moderately severe disability: unable attend to bodily functions or walk without assistance.\n5. Severe disabilities: bedridden, incontinent, requires continuous care and attention.\n6. Dead","24 weeks",{"measure":42,"description":43,"timeFrame":44},"Change in blood inflammatory markers","Change in white blood cell count from baseline to day 7 visit","7 days",{"measure":46,"description":47,"timeFrame":40},"Quantitative neurocognitive performance Z-score","Quantitative neurocognitive performance Z-score scaled to Ugandan population adult norms where population average = 0. Performance is Z-scored such that performance that is one standard deviation better than average is +1 and one standard deviation worse is -1.",{"measure":49,"description":50,"timeFrame":36},"Change in PCR cycle threshold (Ct) value in CSF","Change in PCR cycle threshold (Ct) value in CSF from baseline to Day 7 and 14 visits.",{"measure":52,"description":53,"timeFrame":54},"Altered Mental Status over time","Number of days with Glasgow Coma Scale score = 15 within the first 10 days","10 days",{"measure":56,"description":57,"timeFrame":40},"Additional corticosteroids use","Additional corticosteroids use in TBM survivors (beyond initial use)",{"measure":59,"description":60,"timeFrame":36},"Change in CSF glcuose","Change in CSF glcuose from baseline to day 7 to day 14",{"measure":62,"description":63,"timeFrame":44},"Change in serum C-reactive protein","Change in serum C-reactive protein (CRP) from baseline to day 7",{"allocation":65,"interventionModel":66,"interventionModelDescription":11,"primaryPurpose":67,"observationalModel":11,"timePerspective":11,"maskingInfo":68},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":69,"maskingDescription":11,"whoMasked":11},"NONE",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"BPaLMZ Regimen","EXPERIMENTAL","bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)",[76],"Drug: BPaLMZ Regimen",{"label":78,"type":79,"description":80,"interventionNames":11},"Standard of Care Regimen","NO_INTERVENTION","rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy",[82],{"type":83,"name":72,"description":84,"armGroupLabels":85,"otherNames":11},"DRUG","bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide",[72],[87],{"name":88,"affiliation":5,"role":89},"David Boulware, MD","PRINCIPAL_INVESTIGATOR",[91,95],{"name":88,"role":92,"phone":93,"phoneExt":11,"email":94},"CONTACT","612-624-9996","coat.trial@gmail.com",{"name":96,"role":92,"phone":97,"phoneExt":11,"email":98},"Darlisha Williams, MPH","612-624-0469","will1223@umn.edu",[100,118],{"facility":101,"status":102,"city":103,"state":11,"zip":11,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Infectious Diseases Institute","RECRUITING","Kampala","Uganda","UG",{"type":107,"coordinates":108},"Point",[109,110],32.58219,0.31628,{"lat":110,"lon":109},[113,116],{"name":114,"role":92,"phone":11,"phoneExt":11,"email":115},"Suzan Namombwe, MBChB","snamombwe@idi.co.ug",{"name":117,"role":89,"phone":11,"phoneExt":11,"email":11},"David B Meya, MBChB, MMed, PhD",{"facility":119,"status":102,"city":120,"state":11,"zip":11,"country":104,"countryCode":105,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Mbarara University of Science and Technology","Mbarara",{"type":107,"coordinates":122},[123,124],30.64851,-0.60467,{"lat":124,"lon":123},[127],{"name":128,"role":92,"phone":129,"phoneExt":11,"email":130},"Conrad Muzoora, MBChB MMed","256772547175","conradmuzoora@gmail.com",{"type":132,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","David Boulware","McKnight Distinguished Professor",[136,138,139,141,142,144],{"name":137,"class":6},"Infectious Diseases Institute, Uganda",{"name":5,"class":6},{"name":140,"class":6},"Brighton & Sussex Medical School",{"name":119,"class":6},{"name":143,"class":6},"Radboud University Medical Center",{"name":145,"class":146},"Meningitis Foundation","UNKNOWN","100610453","phase-2-b-palmz-for-tb-meningitis-100610453",false,"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","ALL","18 Years",{"count":157,"type":158},240,"ESTIMATED","INTERVENTIONAL",[161],"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.",[164,165,166,167],"Tuberculous Meningitis","HIV","Meningitis","TB - Tuberculosis","2026-07-28",{"date":170,"type":171},"2026-07-30","ACTUAL",{"date":168,"type":171},{"date":174,"type":158},"2030-09-30",{"name":133,"class":6},2]