[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Mongolia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100559772","phase-2-bedaquiline-roll-out-evidence-in-contacts-and-people-living-with-hiv-to-prevent-tb-100559772",false,"NCT06568484","Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB","Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)","BREACH-TB","INCLUSION CRITERIA\n\nFor Index Patient\n\n• Any age\n\n* A diagnosis of bacteriologically proven pulmonary TB\n* Initiated on treatment for pulmonary TB within the past 90 days\n* Have at least one close contact that is likely to be eligible for the study\n\nFor PLHIV Indication\n\nIndividuals must meet all of the following inclusion criteria to participate in this study:\n\n* On a dolutegravir-based or other approved integrase inhibitor antiretroviral therapy (ART) regimen that does not interact with bedaquiline or rifapentine.\n\n  * If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment\n  * If a participant is not currently on ART or is ART-naïve, the participant must have started a dolutegravir-based ART regimen prior to Enrollment.\n* PLHIV who meet criteria for a TBD close contact should be enrolled under the close contact indication\n\nFor Close Contact Indication (DS- or RR-TB Index Patient)\n\n* Definition of Close Contact (either\u002For):\n\n  o Lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the Index Patient for one or more nights ≤ 90 days prior to the Index Patient starting TB treatment\n\n  o Has shared more than four hours of indoor airspace with the Index Patient during any one-week period ≤ 90 days prior to the Index Patient starting TB treatment. This may include indoor airspace within or outside the home.\n* Close contacts must be in one of the following high-risk groups:\n\n  * All children 0 to \\\u003C5 years old at the time of Enrollment, regardless of LTBI or HIV status\n  * Adults, adolescents, and children ≥5 years of age who are TBI test positive (either skin test positive\\* or IGRA-positive) and whose HIV status is negative, indeterminate, or unknown.\n  * Adults, adolescents, and children ≥5 years of age who have a documented HIV infection regardless of TBI test status.\n\nUniversal Enrollment Inclusion Criteria for PLHIV and Close Contacts of DS- or RR-TB Index Patient\n\nA. Ability and willingness of participant (and\u002For parent\u002Fguardian) to provide informed consent (and assent, as applicable)\n\nB. Documentation of HIV Status\n\nFor participants \\>=18 months of age known to be PLHIV:\n\n* Certified copy of HIV clinic card or\n* Certified copy of HIV testing that includes date, assay used and result\n\nFor participants \\\u003C18 months of age who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three months prior to screening and\u002For result is not available:\n\n• HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period.\n\nFor participants \\\u003C18 months known to be CLHIV:\n\n• Certified copies of HIV DNA and\u002For RNA testing that includes date, assay used, and result\n\nFor participants \\\u003C18 months who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three months prior to screening and\u002For result is not available:\n\n• HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period\n\nC. Documentation of ART\n\n* All PLHIV (for PLHIV indication and CC that are PLHIV) must be on a dolutegravir-based or other approved integrase inhibitor ART regimen that does not interact with bedaquiline or rifapentine.\n* If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment.\n* If a participant is not currently on ART or is ART-naïve, they must have started a dolutegravir-based ART regimen prior to Enrollment.\n\nD. Chest radiograph without evidence of active TBD, performed within 30 days prior to Enrollment\n\nE. The following laboratory values obtained within 30 days prior to Enrollment.\n\n* Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal\n* Total bilirubin ≤ 2.5 times the upper limit of normal\n* Alkaline phosphatase ≤ 3 times the upper limit of normal\n* Creatinine clearance ≥ 29 ml\u002Fmin\n* Serum potassium at or above the lower limit of normal\n* Serum magnesium at or above the lower limit of normal\n* Serum calcium at or above the lower limit of normal\n* Platelet count of ≥ 50,000 \u002Fmm3\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n\nF. Pregnancy test (for study candidates of childbearing potential\\*)\n\n• Negative serum or urine pregnancy test within 7 days prior to enrollment.\n\n\\*NOTE: Participants of childbearing potential are defined as females who have reached menarche or who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).\n\nEXCLUSION CRITERIA\n\nExclusion Criteria for Index Patient A. Unwilling or unable to provide informed consent B. No close contacts likely to be eligible for the study C. Study staff unable to obtain status of TB drug susceptibility or resistance D. Known bedaquiline resistance of M. tb isolate E. Known fluoroquinolone resistance of M. tb isolate (for Index Patients with RR-TB)\n\nExclusion Criteria for PLHIV and Close Contacts of DS- or RR-TB Index Patient\n\nA. Unwilling or unable to provide informed consent\n\nB. Weight ≤ 3 kg\n\nC. A current diagnosis of confirmed or probable or possible pulmonary or extrapulmonary TB at time of enrollment or confirmed or unconfirmed TB for children.\n\nD. Previously completed treatment for TBD.\n\nE. Prior completion of TPT (including but not limited to 6 or 9H, 1HP, 3HP, 4R, 3HR, 6Lfx) \\*\n\n\\*NOTE: Completion of TBD treatment or TPT based on the opinion of the site investigator that a sufficient course of TPT was taken to constitute treatment completion\n\nF. Current enrollment into another therapeutic clinical trial (See Section 5.8).\n\nG. Any of the following medical conditions:\n\n* Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hemodialysis or peritoneal dialysis\n* Severe hepatic impairment (Child-Pugh C)\n* Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and\u002For light stools within 90 days prior to enrollment\n* Severe cardiac arrythmia requiring medication\n* Peripheral neuropathy ≥ Grade 2 (DAIDS)\n* Diagnosis of porphyria at any time prior to study enrollment\n* Corrected QTcF (Fridericia's formula) of \\>460 msec\n* Unable to take oral medication\n* Active drug or alcohol use or dependence that, in the site investigator's opinion, would interfere with adherence to study treatment.\n* Serious illness requiring systemic treatment including parenteral therapy (e.g., antibiotics) and\u002For hospitalization within 30 days prior to Enrollment\n* Prior exposure to bedaquiline or clofazimine\n* Receipt of more than 7 cumulative days of isoniazid, a rifamycin, or a fluoroquinolone in the 90 days prior to enrollment\n* Known bedaquiline resistance in Index Patient\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study drugs or their formulation\n* Currently taking another medication that is prohibited with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 14 days (See Appendix 7)\n* Known pregnancy or breastfeeding\n\nSpecific Exclusion Criteria for Close Contacts of RR-TB Index Patient\n\n* Known fluoroquinolone resistance in Index Patient\n* Severe tendinopathy related to fluoroquinolones","ALL",{"count":19,"type":20},2530,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","A seamless, staged Phase II\u002FIII, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.",[27],"Tuberculosis, Latent",[29],"Bedaquiline","RECRUITING","2026-08-16",{"date":33,"type":34},"2026-08-18","ACTUAL",{"date":36,"type":34},"2026-05-08",{"date":38,"type":20},"2027-09",{"name":40,"class":41},"Johns Hopkins University","OTHER",8,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100549972","phase-2-program-for-rifampicin-resistant-disease-with-stratified-medicine-for-tuberculosis-100549972","NCT06441006","Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis","Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)","PRISM-TB","Inclusion Criteria:\n\nAn individual must meet all of the following inclusion criteria at the time of enrollment in order to participate in this study:\n\n1. Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis, based on sputum Xpert MTB\u002FRIF and Xpert MTB\u002FXDR, and\u002For other validated molecular test, and\u002For phenotypic drug susceptibility testing.\n\n   a. NOTE: TB diagnosis for purposes of meeting this inclusion criterion can be from a study testing laboratory or from an outside laboratory.\n2. Aged ≥ 14 years.\n3. A verifiable address or residence location that is readily available for visiting, willingness to consent to home visits and phone calls, and willingness to inform the study team of any change of address during the treatment and follow-up period.\n4. Ability and willingness of individual to provide written informed consent or written consent from a parent, guardian, or caregiver and assent of the child participant per local ethics committee guidance.\n5. Documentation of negative HIV infection status within 30 days prior to study entry or documentation confirming HIV infection at any time before study entry.\n6. For individuals with HIV: CD4+ cell count ≥ 50 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n7. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n\n   a. NOTE: Dosing of ART and chemoprophylaxis for opportunistic infections should be reflective of local standard of care based on WHO or national guidelines. The following antiretrovirals are disallowed given significant drug-drug interactions with bedaquiline: efavirenz, etravirine, all protease inhibitors, and cobicistat-boosted elvitegravir. The following antiretroviral is disallowed given risk of myelosuppression with linezolid: zidovudine.\n8. For individuals who are pregnant: at screening, evidence by ultrasound of a viable singleton pregnancy with an estimated gestational age at enrollment of ≥ 14 weeks as per screening ultrasound.\n9. Chest radiograph obtained within 14 days prior to study entry.\n\nExclusion Criteria:\n\nAn individual meeting any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded from study participation:\n\n1. Known allergy\u002Fsensitivity, intolerance, or any hypersensitivity to components of study TB drugs or their formulation.\n2. One or more of the following laboratory parameters:\n\n   1. Absolute neutrophil count (ANC) \\\u003C 1000\u002Fmm3.\n   2. Hemoglobin level \\\u003C 8.0 g\u002FdL.\n   3. Serum or plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal.\n   4. Serum or plasma total bilirubin ≥ 3 times the upper limit of normal.\n   5. Serum or plasma creatinine level ≥ 3 times the upper limit of normal.\n   6. Evidence of laboratory values consistent with or equivalent to grade 4 toxicity (i.e., potentially life-threatening).\n   7. NOTE: Persons found not to be eligible due to laboratory abnormalities may be reevaluated within the screening window.\n3. QTcF interval ≥ 480 ms within 5 days prior to study entry.\n4. One or more risk factors for QT prolongation (apart from age and sex) or other uncorrected risk factors for torsades de pointes: evidence of ventricular pre-excitation (Wolff-Parkinson-White syndrome); electrocardiographic evidence of either complete left bundle branch block or right bundle branch block, or incomplete left bundle branch block or right bundle branch block and QRS complex duration ≥ 120 ms on at least one ECG; current pacemaker implant; congestive heart failure; evidence of second- or third-degree heart block; bradycardia defined by sinus rate less than 50 bpm; personal or family history of long QT syndrome; personal history of arrhythmic cardiac disease, with the exception of sinus arrhythmia; personal history of syncope (i.e., cardiac syncope not including syncope due to vasovagal or epileptic causes).\n5. Current grade 2 or higher peripheral neuropathy.\n\n   a. NOTE: Peripheral neuropathy assessment must be obtained within 7 days prior to study entry.\n6. Documentation of Karnofsky Performance Status Score \\\u003C 50 obtained within 14 days prior to study entry.\n7. Known resistance to bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones.\n8. Previous use of any second-line anti-TB drugs for more than 14 days during the 12 months prior to the screening visit date.\n9. Known or presumed central nervous system TB, osteoarticular TB, or miliary\u002Fdisseminated TB in the current TB episode.\n10. Taking any medication that is contraindicated with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 2 weeks.\n11. Any condition (social or medical or psychological) which, in the opinion of the investigator, would make participation unsafe or interfere with adherence to study requirements.\n12. Current enrollment in other therapeutic trials will not be eligible. a. NOTE: Current enrollment of index cases in prevention trials will be allowed on a case-by-case basis, provided that the prevention trial does not include a therapeutic intervention that could affect response to TB treatment.\n\nAll persons who are not eligible for the PRISM-TB trial will be managed according to local routine practice and may enroll in other studies.\n\nCriteria for Exclusion after Entry ('Late Exclusion'):\n\nEnrolled individuals who are subsequently determined to meet the following criteria will be classified as 'late exclusions' and study treatment will be discontinued:\n\n1\\. Bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolone resistance on phenotypic or molecular drug- susceptibility testing from samples collected up to 4 weeks after randomization.","14 Years",{"count":53,"type":20},400,[23,24],"PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2\u002F3 clinical trial for fluoroquinolone-susceptible multidrug-resistant\u002Frifampin-resistant pulmonary tuberculosis (FQ-S MDR\u002FRR-TB). In Stage 1, participants will be randomized among one of three treatment arms (one control and two experimental). Following the interim analysis (at the end of Stage 1) based on DOOR outcome comparisons and the entirety of the data, one of the four possible experimental strategies will be identified and continue into Stage 2. In Stage 2, participants will be randomized among one of two treatment arms (one control and one experimental).\n\nThe trial objective is to identify, among participants with fluoroquinolone-susceptible multidrug-resistant\u002Frifampicin-resistant tuberculosis (FQ-S MDR\u002FRR-TB), the preferred BPaLM strategy of 13 or 17 weeks for participants stratified to receive shorter treatment and 17 or 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, and to evaluate whether this BPaLM strategy has noninferior efficacy to the control strategy at Week 73.",[57,58,59],"Tuberculosis, Pulmonary","Tuberculosis, Multidrug-Resistant","Tuberculosis, MDR",[61,62,29,63,64,65],"Tuberculosis","BPaLM","Pretomanid","Linezolid","Moxifloxacin","2026-07-22",{"date":68,"type":34},"2026-07-24",{"date":70,"type":34},"2025-10-03",{"date":72,"type":20},"2031-08",{"name":74,"class":41},"University of California, San Francisco",6,""]