[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632727":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":42,"centralContacts":46,"locations":53,"responsibleParty":132,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":28,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":28,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":56,"whyStopped":28,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Gates Medical Research Institute","OTHER",[8,15,18],{"label":9,"type":10,"description":11,"interventionNames":12},"BPAL\u002FNAM1500","EXPERIMENTAL","Nicotinamide, bedaquiline, pretomanid, linezolid",[13,14],"Drug: Bedaquiline, pretomanid, linezolid","Dietary Supplement: Nicotinamide (NAM)",{"label":16,"type":10,"description":11,"interventionNames":17},"BPAL\u002FNAM2500",[13,14],{"label":19,"type":20,"description":21,"interventionNames":22},"BPAL","ACTIVE_COMPARATOR","Bedaquiline, pretomanid, linezolid",[13],[24,29,32,35],{"type":25,"name":21,"description":26,"armGroupLabels":27,"otherNames":28},"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",[9],null,{"type":25,"name":21,"description":30,"armGroupLabels":31,"otherNames":28},"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",[16],{"type":25,"name":21,"description":33,"armGroupLabels":34,"otherNames":28},"Group 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days",[19],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"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",[9,16],[41],"Nicotinamide also abbreviated as NAM and also known as niacinamide .",[43],{"name":44,"affiliation":5,"role":45},"Gates MRI","STUDY_DIRECTOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","+857-702-2108","Clinical.trials@gatesmri.org",{"name":44,"role":48,"phone":52,"phoneExt":28,"email":50},"+1-866-789-5757",[54,79,98,117],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Wits RHI - Shandukani Research","RECRUITING","Johannesburg","Gauteng","2001","South 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Innovation","7700",{"type":63,"coordinates":121},[105,106],{"lat":106,"lon":105},[124,128,131],{"name":125,"role":48,"phone":126,"phoneExt":28,"email":127},"Rodney Dawson, MD","021 406 6850","rodney.dawson@uct.ac.za",{"name":129,"role":48,"phone":28,"phoneExt":126,"email":130},"Shanel Linde","shanel.linde@uct.ac.za",{"name":125,"role":78,"phone":28,"phoneExt":28,"email":28},{"type":133,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[135],{"name":136,"class":137},"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":149,"type":150},165,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156],"Drug Susceptible Pulmonary Tuberculosis",[158,159,160,161,162],"Nicotinamide","bedaquiline","pretomanid","linezolid","drug-susceptible pulmonary tuberculosis","2026-06-30",{"date":165,"type":166},"2026-07-02","ACTUAL",{"date":168,"type":166},"2026-04-17",{"date":170,"type":150},"2027-06-14",{"name":5,"class":6},4]