{"id":"high-dose-rifampicin","safety":{"commonSideEffects":[{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Drug-drug interactions"},{"rate":null,"effect":"Gastrointestinal disturbance"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Orange discoloration of body fluids"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rifampicin is a well-established antibiotic that binds to bacterial RNA polymerase, blocking transcription in mycobacteria. At high doses, it may also have immunomodulatory effects that enhance host immune responses against intracellular pathogens. This combination of direct antimicrobial activity and immune enhancement is being investigated in phase 3 trials.","oneSentence":"High-dose rifampicin inhibits bacterial RNA polymerase to suppress mycobacterial growth and modulate immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:41:49.390Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis (likely indication given Seoul National University Hospital context and high-dose formulation)"}]},"trialDetails":[{"nctId":"NCT07374224","phase":"PHASE1","title":"A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet","status":"RECRUITING","sponsor":"Guangzhou Lupeng Pharmaceutical Company LTD.","startDate":"2026-03-05","conditions":"Clinical Pharmacology","enrollment":28},{"nctId":"NCT07429331","phase":"PHASE1","title":"Drug Interaction and Food Effect Study of CS0159","status":"NOT_YET_RECRUITING","sponsor":"Cascade Pharmaceuticals, Inc","startDate":"2026-03","conditions":"Healthy Volunteers","enrollment":32},{"nctId":"NCT06498414","phase":"PHASE2, PHASE3","title":"Shorter and Safer Treatment Regimens for Latent TB","status":"RECRUITING","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2025-06-10","conditions":"Tuberculosis Infection, Latent","enrollment":1800},{"nctId":"NCT07069582","phase":"PHASE1","title":"Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women","status":"NOT_YET_RECRUITING","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2026-04-01","conditions":"Tuberculosis Infection, Healthy Volunteer, Breastfeeding","enrollment":60},{"nctId":"NCT04951986","phase":"PHASE3","title":"Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Cape Town","startDate":"2021-08-11","conditions":"Disseminated Tuberculosis, HIV","enrollment":732},{"nctId":"NCT04738812","phase":"PHASE3","title":"Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2022-04-21","conditions":"Tuberculosis, HIV-1-infection, Immuno-Deficiency","enrollment":1330},{"nctId":"NCT05118490","phase":"PHASE4","title":"Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Aurum Institute NPC","startDate":"2023-07-19","conditions":"HIV Seropositivity, Tuberculosis, Household Contact","enrollment":1000},{"nctId":"NCT05383742","phase":"PHASE2","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","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2023-12-07","conditions":"Tuberculous Meningitis","enrollment":330},{"nctId":"NCT00042289","phase":"","title":"Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-06-09","conditions":"HIV Infections","enrollment":1578},{"nctId":"NCT05069688","phase":"PHASE1","title":"Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2023-07-07","conditions":"Pediatric HIV Infection, Tuberculosis Infection","enrollment":20},{"nctId":"NCT05807399","phase":"PHASE2","title":"PanACEA - STEP2C -01","status":"RECRUITING","sponsor":"Michael Hoelscher","startDate":"2023-04-14","conditions":"Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis","enrollment":390},{"nctId":"NCT02563327","phase":"PHASE3","title":"Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis","status":"COMPLETED","sponsor":"Centers for Disease Control and Prevention","startDate":"2016-05-30","conditions":"Tuberculosis","enrollment":53},{"nctId":"NCT04521803","phase":"PHASE2","title":"High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis","status":"RECRUITING","sponsor":"University of Cape Town","startDate":"2022-01-10","conditions":"Tuberculous Pericarditis, HIV Status","enrollment":60},{"nctId":"NCT03301038","phase":"PHASE2","title":"Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria","status":"RECRUITING","sponsor":"Children's Hospital of Philadelphia","startDate":"2018-07-25","conditions":"Idiopathic Infantile Hypercalcaemia - Severe Form, Genetic Disease, Hypercalcemia, Idiopathic, of Infancy","enrollment":60},{"nctId":"NCT03988933","phase":"PHASE2","title":"2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB.","status":"COMPLETED","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2019-09-20","conditions":"Latent Tuberculosis","enrollment":1368},{"nctId":"NCT04260477","phase":"PHASE3","title":"Novel Triple-dose Tuberculosis Retreatment Regimen","status":"RECRUITING","sponsor":"Institute of Tropical Medicine, Belgium","startDate":"2021-03-01","conditions":"Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis","enrollment":370},{"nctId":"NCT06701136","phase":"PHASE1","title":"Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Jiatan Pharmatech Co., Ltd","startDate":"2025-05-12","conditions":"Rifampicin-Resistant Pulmonary Tuberculosis Patients","enrollment":16},{"nctId":"NCT04021121","phase":"PHASE2","title":"Adjunctive Linezolid for the Treatment of Tuberculous Meningitis","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2021-05-05","conditions":"Tuberculosis, Meningeal","enrollment":40},{"nctId":"NCT04166474","phase":"PHASE4","title":"Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin","status":"COMPLETED","sponsor":"Helen Reynolds","startDate":"2021-11-18","conditions":"Hiv, Tuberculosis","enrollment":36},{"nctId":"NCT04437836","phase":"PHASE1, PHASE2","title":"Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic","status":"COMPLETED","sponsor":"Kilimanjaro Clinical Research Institute","startDate":"2019-07-01","conditions":"Clinical Trial","enrollment":31},{"nctId":"NCT04145258","phase":"PHASE3","title":"Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis","status":"RECRUITING","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2021-02-07","conditions":"Tuberculous Meningitis","enrollment":768},{"nctId":"NCT04694586","phase":"PHASE2","title":"Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide","status":"SUSPENDED","sponsor":"University Hospital, Linkoeping","startDate":"2022-11-30","conditions":"Tuberculosis, Pulmonary","enrollment":40},{"nctId":"NCT06178666","phase":"NA","title":"A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi","status":"UNKNOWN","sponsor":"Liverpool School of Tropical Medicine","startDate":"2024-03-01","conditions":"Tuberculosis","enrollment":30},{"nctId":"NCT05917340","phase":"PHASE3","title":"Intensified Short Course Regimen for TBM in Adults","status":"NOT_YET_RECRUITING","sponsor":"Indian Council of Medical Research","startDate":"2024-03","conditions":"Tuberculous Meningitis","enrollment":372},{"nctId":"NCT03537495","phase":"PHASE2","title":"Pharmacokinetic Study of Linezolid for TB Meningitis","status":"COMPLETED","sponsor":"Universitas Padjadjaran","startDate":"2021-06-21","conditions":"Tuberculosis, Meningeal, Linezolid","enrollment":36},{"nctId":"NCT03237182","phase":"PHASE4","title":"The Individualized M(X) Drug-resistant TB Treatment Strategy Study","status":"TERMINATED","sponsor":"Centre for the AIDS Programme of Research in South Africa","startDate":"2017-06-14","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":205},{"nctId":"NCT02581527","phase":"PHASE3","title":"A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"St George's, University of London","startDate":"2017-02-01","conditions":"Pulmonary Tuberculosis","enrollment":672},{"nctId":"NCT03982277","phase":"PHASE2","title":"Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy","status":"COMPLETED","sponsor":"Makerere University","startDate":"2019-04-30","conditions":"Tuberculosis","enrollment":130},{"nctId":"NCT04044001","phase":"PHASE1, PHASE2","title":"BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)","status":"COMPLETED","sponsor":"Michael Hoelscher","startDate":"2019-11-15","conditions":"Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis","enrollment":77},{"nctId":"NCT05316857","phase":"PHASE1","title":"DDI Study of Orelabrutinib","status":"COMPLETED","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2021-12-16","conditions":"Healthy Person","enrollment":36},{"nctId":"NCT02467608","phase":"PHASE2, PHASE3","title":"Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"Orient Pharma Co., Ltd.","startDate":"2012-12-06","conditions":"Pulmonary Tuberculosis","enrollment":557},{"nctId":"NCT04553406","phase":"PHASE2","title":"Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease","status":"TERMINATED","sponsor":"Spero Therapeutics","startDate":"2020-12-03","conditions":"Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease","enrollment":2},{"nctId":"NCT05124678","phase":"PHASE2","title":"Pharmacogenetics-guided Isoniazid Dosing in TB-HIV","status":"UNKNOWN","sponsor":"Makerere University","startDate":"2021-12-07","conditions":"Tuberculosis","enrollment":40},{"nctId":"NCT04565574","phase":"PHASE1","title":"A Study to Assess the Effect of Food Intake and Drug-drug Interactions of E7090 When Co-administered With Rabeprazole or Rifampin in Healthy Participants","status":"COMPLETED","sponsor":"Eisai Co., Ltd.","startDate":"2020-10-16","conditions":"Healthy Participants","enrollment":42},{"nctId":"NCT02958709","phase":"PHASE1, PHASE2","title":"Optimizing Treatment to Improve TBM Outcomes in Children","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2017-02-22","conditions":"Tuberculosis, Meningeal","enrollment":38},{"nctId":"NCT03927313","phase":"PHASE2","title":"Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM","status":"COMPLETED","sponsor":"University of Cape Town","startDate":"2019-06-12","conditions":"Tuberculosis Meningitis, HIV-1-infection","enrollment":52},{"nctId":"NCT03384121","phase":"PHASE1","title":"The Antibiotic Rifampin to Reduce High Levels of Blood and Urine Calcium in IIH","status":"UNKNOWN","sponsor":"The Hospital for Sick Children","startDate":"2018-02-22","conditions":"Idiopathic Infantile Hypercalcemia - Mild Form","enrollment":5},{"nctId":"NCT02599493","phase":"PHASE4","title":"EVRIOS : Comparative Evaluation of Low Versus High Doses of Rifampicin","status":"COMPLETED","sponsor":"Rennes University Hospital","startDate":"2016-01","conditions":"Osteoarticular Infection","enrollment":544},{"nctId":"NCT04525235","phase":"PHASE1","title":"Phenotyping of High Dose Rifampicin","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2021-01-07","conditions":"Tuberculosis","enrollment":25},{"nctId":"NCT04768231","phase":"PHASE2","title":"Rifampicin at High Dose for Difficult-to-Treat Tuberculosis","status":"UNKNOWN","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","startDate":"2021-04-01","conditions":"Tuberculosis","enrollment":130},{"nctId":"NCT03561753","phase":"PHASE4","title":"Pilot Clinical Trial of PRS TB Regimen I - Phase II","status":"COMPLETED","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2017-12-01","conditions":"Pulmonary Tuberculosis TB in Sputum: (+) Microscopy","enrollment":97},{"nctId":"NCT04485156","phase":"PHASE3","title":"Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)","status":"NOT_YET_RECRUITING","sponsor":"Seoul National University Hospital","startDate":"2020-09","conditions":"Tuberculosis, Pulmonary","enrollment":926},{"nctId":"NCT04118842","phase":"PHASE1","title":"A Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Rifampicin","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2019-10-17","conditions":"Solid Tumors","enrollment":40},{"nctId":"NCT03862248","phase":"PHASE3","title":"Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More","status":"WITHDRAWN","sponsor":"Institute of Tropical Medicine, Belgium","startDate":"2019-09-30","conditions":"Tuberculosis, Pulmonary","enrollment":""},{"nctId":"NCT03563599","phase":"PHASE2","title":"A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)","status":"COMPLETED","sponsor":"Qurient Co., Ltd.","startDate":"2018-07-23","conditions":"Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB","enrollment":60},{"nctId":"NCT01392911","phase":"PHASE2","title":"Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2011-06","conditions":"Pulmonary Tuberculosis (TB)","enrollment":128},{"nctId":"NCT01408914","phase":"PHASE2","title":"Trial of High-Dose Rifampin in Patients With TB","status":"COMPLETED","sponsor":"Harvard University Faculty of Medicine","startDate":"2013-09","conditions":"Tuberculosis","enrollment":180},{"nctId":"NCT01785186","phase":"PHASE2","title":"Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design","status":"COMPLETED","sponsor":"Michael Hoelscher","startDate":"2013-04","conditions":"Tuberculosis, Pulmonary","enrollment":365},{"nctId":"NCT01986543","phase":"PHASE2","title":"Interaction Between High Dose Rifampicine and Efavirenz in Pulmonary Tuberculosis and HIV Co-infection","status":"UNKNOWN","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2013-12","conditions":"Tuberculosis, HIV","enrollment":105},{"nctId":"NCT03116893","phase":"PHASE1","title":"Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2017-04-19","conditions":"Healthy","enrollment":15},{"nctId":"NCT02169882","phase":"PHASE2, PHASE3","title":"High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study","status":"COMPLETED","sponsor":"Universitas Padjadjaran","startDate":"2014-12-01","conditions":"Tuberculosis, Meningeal","enrollment":60},{"nctId":"NCT01349192","phase":"PHASE2","title":"Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)","status":"TERMINATED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2011-04","conditions":"Cystic Fibrosis, Methicillin-resistant Staphylococcus Aureus","enrollment":47},{"nctId":"NCT02387242","phase":"PHASE1","title":"Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers","status":"SUSPENDED","sponsor":"National University Hospital, Singapore","startDate":"2015-02","conditions":"Tuberculosis","enrollment":18},{"nctId":"NCT01845298","phase":"NA","title":"Immune Activation and Drug Absorption in HIV-Infected Patients","status":"COMPLETED","sponsor":"Drexel University","startDate":"2014-06","conditions":"HIV Infection","enrollment":7},{"nctId":"NCT01218620","phase":"PHASE1","title":"Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2010-09","conditions":"Adult Solid Neoplasm","enrollment":17},{"nctId":"NCT00760149","phase":"PHASE2","title":"Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2010-07","conditions":"Tuberculosis","enrollment":150},{"nctId":"NCT01144000","phase":"PHASE2","title":"Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection","status":"UNKNOWN","sponsor":"Andrej Trampuz","startDate":"2012-06","conditions":"Staphylococcal Infections","enrollment":60},{"nctId":"NCT01158755","phase":"PHASE2","title":"Intensified Treatment Regimens for TB Meningitis: PK, PD and Tolerability Study","status":"COMPLETED","sponsor":"Universitas Padjadjaran","startDate":"2010-10","conditions":"Meningitis, Tuberculous, Pharmacokinetics, Pharmacodynamics","enrollment":60},{"nctId":"NCT00523458","phase":"PHASE4","title":"A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV","status":"TERMINATED","sponsor":"Stanford University","startDate":"2007-07","conditions":"HIV Infections, Tuberculosis","enrollment":5}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":93,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"High-dose rifampicin","genericName":"High-dose rifampicin","companyName":"Seoul National University Hospital","companyId":"seoul-national-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"High-dose rifampicin inhibits bacterial RNA polymerase to suppress mycobacterial growth and modulate immune responses. Used for Tuberculosis (likely indication given Seoul National University Hospital context and high-dose formulation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}