[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632727":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":43,"interventions":59,"overallOfficials":77,"centralContacts":81,"locations":88,"responsibleParty":167,"collaborators":169,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":36,"eligibilityCriteria":179,"healthyVolunteers":175,"sex":180,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":36,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":91,"whyStopped":36,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"Gates Medical Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":36},[9,13,16,18,20,22],{"measure":10,"description":11,"timeFrame":12},"Bactericidal Activity","Proportion of participants with sputum culture conversion SCC to negative for Mtb in MGIT liquid culture by Week 8 (Day 56, End of Treatment \\[EOTx\\]), defined as two consecutive Mtb-negative culture results, collected at least 1 day apart (i.e., not collected on the same day), occurring by Week 9 (Day 64) with no subsequent Mtb-positive cultures through Week 9 (Day 64)","From randomization through Day 64 (EOT)",{"measure":14,"description":15,"timeFrame":12},"Safety: SAEs","Proportion of participants with this event",{"measure":17,"description":15,"timeFrame":12},"Safety: TEAEs",{"measure":19,"description":15,"timeFrame":12},"Safety: AESIs",{"measure":21,"description":15,"timeFrame":12},"Safety: TEAEs leading to treatment discontinuation",{"measure":23,"description":15,"timeFrame":12},"Safety: TEAEs leading to NAM dose reduction",[25,28,32],{"measure":10,"description":26,"timeFrame":27},"Time to Sputum culture conversion to negative of Mtb in MGIT sputum culture.","Randomization through Day 64 (EOT)",{"measure":29,"description":30,"timeFrame":31},"Bactericidal activity","Proportion of participants with Mtb-negative MGIT sputum culture(s) at Week 4 (Day 29) and Week 8 (Day 56, EOTx), where confirmation of negative sputum culture at subsequent study timepoint is not required.","Randomization through Day 56 (EOTx)",{"measure":33,"description":34,"timeFrame":35},"Evaluate the PK of NAM when administered with BPaL in Group 1 and 2","Concentrations of NAM and its primary metabolite by measuring specific PK parameters at Day 1 and Day 14 (see protocol).","Day 1 and Day 14",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE",[44,51,54],{"label":45,"type":46,"description":47,"interventionNames":48},"BPAL\u002FNAM1500","EXPERIMENTAL","Nicotinamide, bedaquiline, pretomanid, linezolid",[49,50],"Drug: Bedaquiline, pretomanid, linezolid","Dietary Supplement: Nicotinamide (NAM)",{"label":52,"type":46,"description":47,"interventionNames":53},"BPAL\u002FNAM2500",[49,50],{"label":55,"type":56,"description":57,"interventionNames":58},"BPAL","ACTIVE_COMPARATOR","Bedaquiline, pretomanid, linezolid",[49],[60,64,67,70],{"type":61,"name":57,"description":62,"armGroupLabels":63,"otherNames":36},"DRUG","Group 1 (Approximately 55 participants), Combination of NAM 1500 mg twice daily (BID) with bedaquiline (200 mg once daily \\[QD\\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days",[45],{"type":61,"name":57,"description":65,"armGroupLabels":66,"otherNames":36},"Group 2 (Approximately 55 participants): Combination of NAM 2500 mg BID with bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days",[52],{"type":61,"name":57,"description":68,"armGroupLabels":69,"otherNames":36},"Group 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days",[55],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"DIETARY_SUPPLEMENT","Nicotinamide (NAM)","Group 1 (Approximately 55 participants), Combination of NAM 2500 mg twice daily (BID) with bedaquiline (200 mg once daily \\[QD\\]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days",[45,52],[76],"Nicotinamide also abbreviated as NAM and also known as niacinamide .",[78],{"name":79,"affiliation":5,"role":80},"Gates MRI","STUDY_DIRECTOR",[82,86],{"name":79,"role":83,"phone":84,"phoneExt":36,"email":85},"CONTACT","+857-702-2108","Clinical.trials@gatesmri.org",{"name":79,"role":83,"phone":87,"phoneExt":36,"email":85},"+1-866-789-5757",[89,114,133,152],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Wits RHI - Shandukani Research","RECRUITING","Johannesburg","Gauteng","2001","South Africa","ZA",{"type":98,"coordinates":99},"Point",[100,101],28.04363,-26.20227,{"lat":101,"lon":100},[104,108,112],{"name":105,"role":83,"phone":106,"phoneExt":36,"email":107},"Nkosiphile Ndlovu, MD","011 358 5300","nkndlovu@wrhi.ac.za",{"name":109,"role":83,"phone":110,"phoneExt":36,"email":111},"Zikhona Njengele Tetyana","083 3642","znjengele-tetyana@wrhi.ac.za",{"name":105,"role":113,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"facility":115,"status":91,"city":116,"state":93,"zip":117,"country":95,"countryCode":96,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"The Aurum Institute Clinical Research Site - Pretoria","Pretoria","87",{"type":98,"coordinates":119},[120,121],28.18783,-25.74486,{"lat":121,"lon":120},[124,128,132],{"name":125,"role":83,"phone":126,"phoneExt":36,"email":127},"Vaneshree Govender, MD","012 844 0145","vgovender@auruminstitute.org",{"name":129,"role":83,"phone":130,"phoneExt":36,"email":131},"Innocent Shibambo","082 495 9556","ishibambo@auruminstitute.org",{"name":125,"role":113,"phone":36,"phoneExt":36,"email":36},{"facility":134,"status":91,"city":135,"state":136,"zip":137,"country":95,"countryCode":96,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"TASK Clinical Research Centre","Cape Town","Western Cape","7530",{"type":98,"coordinates":139},[140,141],18.42322,-33.92584,{"lat":141,"lon":140},[144,148,151],{"name":145,"role":83,"phone":146,"phoneExt":36,"email":147},"Andrew Parker, MD","021 9171044","dr.andrew@task.org.za",{"name":149,"role":83,"phone":146,"phoneExt":36,"email":150},"Lukhanyile Ketelo","l.ketelo@taskclinical.com",{"name":145,"role":113,"phone":36,"phoneExt":36,"email":36},{"facility":153,"status":91,"city":135,"state":136,"zip":154,"country":95,"countryCode":96,"cosmosGeoPoint":155,"geoPoint":157,"contacts":158},"Centre of Tuberculosis Research Innovation","7700",{"type":98,"coordinates":156},[140,141],{"lat":141,"lon":140},[159,163,166],{"name":160,"role":83,"phone":161,"phoneExt":36,"email":162},"Rodney Dawson, MD","021 406 6850","rodney.dawson@uct.ac.za",{"name":164,"role":83,"phone":36,"phoneExt":161,"email":165},"Shanel Linde","shanel.linde@uct.ac.za",{"name":160,"role":113,"phone":36,"phoneExt":36,"email":36},{"type":168,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[170],{"name":171,"class":172},"IQVIA RDS Inc.","INDUSTRY","100632727","phase-2-bactericidal-activity-and-safety-of-nicotinamide-in-combination-with-bedaquiline-pretomanid-and-linezolid-in-drug-susceptible-pulmonary-tuberculosis-100632727",false,"NCT07517445","Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis","A Phase 2, Open-label, Randomized Controlled Trial to Assess the Safety, Bactericidal Activity, and Pharmacokinetics of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Adults With Drug-susceptible Pulmonary Tuberculosis","Inclusion Criteria:\n\n* Age 18-65 years at consent\n* Body weight 40-100 kg at screening\n* Written informed consent obtained\n* Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive\n\n  * ≥1+ AFB smear OR positive Xpert semi-quantitative result\n  * Molecular confirmation of M. tuberculosis\n* Chest X-ray consistent with TB (Investigator assessment)\n* Able to spontaneously produce sputum\n* Contraception requirements met\n* Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence\n* Males: contraception or abstinence through 90 days post-dose\n\nExclusion Criteria:\n\n* Prior TB within 3 years, \\>1 prior episode, or anti-TB treatment within 60 days\n* Extrapulmonary TB (except non-significant pleural\u002Flymph node disease)\n* Clinically significant comorbidities or substance abuse impacting safety\u002Fcompliance\n* Pregnant or breastfeeding\n* HIV-positive AND any of the following:\n* Not on ART or on ART \\\u003C3 months\n* CD4 \\\u003C200 cells\u002FµL\n* Viral load \\>200 copies\u002FmL\n* AIDS-defining illness (other than pulmonary TB)\n* Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)\n* Clinically significant ECG abnormality\n* Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)","ALL","18 Years","65 Years",{"count":184,"type":185},165,"ESTIMATED","INTERVENTIONAL",[188],"PHASE2","The purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.",[191],"Drug Susceptible Pulmonary Tuberculosis",[193,194,195,196,197],"Nicotinamide","bedaquiline","pretomanid","linezolid","drug-susceptible pulmonary tuberculosis","2026-06-30",{"date":200,"type":201},"2026-07-02","ACTUAL",{"date":203,"type":201},"2026-04-17",{"date":205,"type":185},"2027-06-14",{"name":5,"class":6},4]