Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-06 @ 6:40 AM
Study NCT ID:
NCT07209761
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C493870', 'term': 'bedaquiline'}, {'id': 'C410767', 'term': 'pretomanid'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study with blinded endpoint adjudication of the primary efficacy outcome. Certain sponsor team members will be blinded to treatment assignments to minimize potential bias as much as possible'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study has two parallel cohorts based on fluoroquinolone sensitivity status, each with an experimental arm and a control arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 532}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate health-related quality of life measures in the experimental and SoC arms.', 'timeFrame': 'From baseline to Week 52 and end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)', 'description': 'Changes from baseline in SF-36v2 Physical and Mental Component Summary scores, SF-6D utility score, SGRQ Total score and subscores (Symptoms, Activity, and Impacts), CAAT total score and subscores (symptom burden items and daily impacts items), and descriptive summaries of PRO-CTCAE adverse event frequency, severity, and interference over time.'}, {'measure': 'To estimate the difference in the proportion of unfavorable outcomes between the investigational and SoC arms at specified timepoints.', 'timeFrame': 'At 10 months post-treatment completion and at 16 months post-randomization', 'description': 'Proportion of participants with unfavorable outcome at specified timepoints beyond the primary endpoint assessment at 12 months post-randomization to evaluate durability of treatment effect.'}, {'measure': 'To estimate the difference in the proportion of microbiological relapse between the investigational and SoC arms at specified timepoints.', 'timeFrame': 'At 10 months post-treatment completion and at 16 months post-randomization', 'description': 'Proportion of participants with microbiological relapse at specified timepoints beyond the primary endpoint assessment at 12 months post-randomization to evaluate durability of treatment effect.'}, {'measure': 'To evaluate the development of resistance and cross-resistance to anti-TB drugs in all treatment arms.', 'timeFrame': 'From baseline through Week 68', 'description': 'Proportion of participants developing drug resistance during the trial and proportion of participants developing cross-resistance between bedaquiline and quabodepistat during the trial, as determined by phenotypic drug susceptibility testing and genotyping.'}], 'primaryOutcomes': [{'measure': 'Proportion of participants with unfavorable outcome.', 'timeFrame': 'From randomization to Month 12', 'description': 'Unfavorable outcome is defined as a participant experiencing at least one of the following: death, treatment failure, change in regimen, or sputum culture with growth of Mycobacterium tuberculosis at certain timepoints as follows: Failure to achieve SCC at the end of the treatment period that results in a change in anti-mycobacterial therapy or Relapse during the follow-up period (i.e., the period from end of treatment to Month 12 post-randomization.'}, {'measure': 'Incidence of Grade ≥3 Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Dose Reduction or Discontinuation (Safety and Tolerability).', 'timeFrame': 'From first dose to 2 weeks after end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)', 'description': 'A participant experiencing at least one of the following: Grade 3 toxicity or higher treatment-emergent adverse events (TEAEs), serious TEAEs, or TEAEs leading to dose reduction or discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Time to first occurrence of any event meeting the unfavorable outcome definition.', 'timeFrame': 'From randomization to Month 12', 'description': 'Time to the first occurrence of any event listed under the primary efficacy endpoint.'}, {'measure': 'Time to sputum culture conversion.', 'timeFrame': 'From randomization to end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)', 'description': 'Time from randomization to the first of two consecutive negative sputum cultures taken at least 1 week apart.'}, {'measure': 'Proportion of participants with sputum culture conversion.', 'timeFrame': 'At Week 8 and at end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)', 'description': 'Proportion of participants achieving sputum culture conversion, defined as two consecutive negative cultures taken at least 1 week apart.'}, {'measure': 'Proportion of participants with microbiological relapse.', 'timeFrame': 'From end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL) to Month 12 post-randomization', 'description': 'Proportion of microbiological relapse.'}, {'measure': 'Proportion of participants with adverse events of special interest (AESIs).', 'timeFrame': 'From first dose to 2 weeks after end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)', 'description': 'AESIs include QTc interval prolongation, hepatotoxicity, peripheral neuropathy, optic neuritis, and hematological toxicity.'}, {'measure': 'Proportion of participants with treatment-emergent adverse events (TEAEs).', 'timeFrame': 'From randomization through Week 68', 'description': 'Proportion of participants with TEAEs, Grade 3 or higher TEAEs, and serious TEAEs.'}, {'measure': 'Proportion of time during treatment spent without adverse events.', 'timeFrame': 'From randomization to end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)', 'description': 'Measure of difference in AE-free time during treatment between experimental and standard of care arms.'}, {'measure': 'Proportion of participants who are lost to follow-up.', 'timeFrame': 'From randomization through Week 68', 'description': 'Measure of participant retention throughout the study period.'}, {'measure': 'Proportion of participants with TB-related death.', 'timeFrame': 'From randomization through Week 68', 'description': 'Mortality specifically related to tuberculosis.'}, {'measure': 'Plasma concentrations of each analyte at scheduled visits.', 'timeFrame': 'From randomization through Week 17 (BPaQM and BPaQ only)', 'description': 'Plasma concentrations of trial drugs in experimental arms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Tuberculosis', 'Quabodepistat', 'Bedaquiline', 'Pretomanid', 'Linezolid', 'Moxifloxacin', 'Fluoroquinolone-sensitive TB', 'Fluoroquinolone-resistant TB', 'Drug-resistant TB', 'Shortened TB treatment'], 'conditions': ['Pulmonary Tuberculosis']}, 'descriptionModule': {'briefSummary': 'This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.', 'detailedDescription': 'This is a Phase 3, randomized, open-label, multicenter trial evaluating quabodepistat-containing regimens for rifampicin-resistant/multidrug-resistant (RR/MDR) pulmonary tuberculosis (TB).\n\nThe study aims to enroll 532 participants aged 14 years and older.\n\nThe study has two main cohorts:\n\nFluoroquinolone-sensitive RR/MDR-TB (432 participants):\n\n* Experimental arm: BPaQM (bedaquiline, pretomanid, quabodepistat, moxifloxacin) for 4 months\n* Control arm: BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) for 6 months\n\nFluoroquinolone-resistant RR/MDR-TB (100 participants):\n\n* Experimental arm: BPaQ (bedaquiline, pretomanid, quabodepistat) for 6 months\n* Control arm: BPaL (bedaquiline, pretomanid, linezolid) for 6 months\n\nThe primary efficacy endpoint is an unfavorable outcome by 12 months post-randomization.\n\nSecondary endpoints include time to unfavorable outcome, time to sputum culture conversion, and safety/tolerability assessments. Participants will be followed for 16 months post-randomization.\n\nThe study will be conducted at approximately 40 sites in up to 12 countries.\n\nAn independent Data Monitoring Committee and Endpoint Adjudication Committee will be used in the study.\n\nThe trial aims to evaluate if quabodepistat-containing regimens can shorten treatment duration to 4 months for fluoroquinolone-sensitive RR/MDR-TB and provide a safer alternative to linezolid-containing regimens for both fluoroquinolone-sensitive and fluoroquinolone-resistant RR/MDR-TB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥14 years\n2. Body weight ≥30.0 kg\n3. Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)\n4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')\n5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test\n6. Chest radiograph consistent with active TB disease\n7. Able to provide sputum sample\n8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose\n9. Willing to have HIV test (unless previous positive result confirmed)\n10. For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \\<200 copies/mL, and CD4 count \\>100 cells/mL\n\nExclusion Criteria:\n\n1. Known/suspected resistance to BDQ, PMD, LZD, or QBS\n2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months\n3. Severe extrapulmonary TB\n4. Abnormal laboratory values: ALT/AST \\>2.5×ULN, Total bilirubin \\>1.5×ULN, eGFR \\<60 mL/min/1.73m², Hemoglobin \\<8 g/dL, Platelets \\<100,000 cells/mm³, WBC \\<2.0×10⁹/L, ANC \\<1000 cells/μL, and HbA1c \\>9.0%\n5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment\n6. Co-enrollment in other therapeutic trials\n7. QTcF \\>450 msec (males) or \\>470 msec (females)\n8. Clinically significant cardiovascular disorders\n9. Bleeding disorders\n10. Conditions interfering with X-ray or sputum assessment\n11. Drug allergies/hypersensitivity to study medications\n12. Pregnancy or breastfeeding\n13. Positive drug screen (case-by-case assessment for some substances)\n14. Serious mental disorders\n15. Karnofsky score \\<60\n16. BMI \\<16.0 kg/m²\n17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)\n18. Pulmonary conditions other than TB (silicosis, fibrosis)\n19. Active SARS-CoV-2 infection\n20. Use of prohibited medications\n21. Blood/plasma donation within 30 days\n22. Current use of herbal remedies or traditional medicines"}, 'identificationModule': {'nctId': 'NCT07209761', 'acronym': 'QUANTUM-TB', 'briefTitle': 'A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis', 'orgStudyIdInfo': {'id': '323-201-00013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BPaQM for Fluoroquinolone-sensitive RR/MDR-TB', 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin 400 mg once daily for 17 weeks', 'interventionNames': ['Drug: BPaQM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BPaLM for Fluoroquinolone-sensitive RR/MDR-TB', 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin 400 mg once daily for 26 weeks', 'interventionNames': ['Drug: BPaLM']}, {'type': 'EXPERIMENTAL', 'label': 'BPaQ for Fluoroquinolone-resistant RR/MDR-TB', 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Quabodepistat 30 mg once daily for 26 weeks', 'interventionNames': ['Drug: BPaQ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BPaL for Fluoroquinolone-resistant RR/MDR-TB', 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks', 'interventionNames': ['Drug: BPaL']}], 'interventions': [{'name': 'BPaQM', 'type': 'DRUG', 'otherNames': ['Bedaquiline, Pretomanid, Quabodepistat, Moxifloxacin'], 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin 400 mg once daily for 17 weeks', 'armGroupLabels': ['BPaQM for Fluoroquinolone-sensitive RR/MDR-TB']}, {'name': 'BPaLM', 'type': 'DRUG', 'otherNames': ['Bedaquiline, Pretomanid, Linezolid, Moxifloxacin'], 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin 400 mg once daily for 26 weeks', 'armGroupLabels': ['BPaLM for Fluoroquinolone-sensitive RR/MDR-TB']}, {'name': 'BPaQ', 'type': 'DRUG', 'otherNames': ['Bedaquiline, Pretomanid, Quabodepistat'], 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Quabodepistat 30 mg once daily for 26 weeks', 'armGroupLabels': ['BPaQ for Fluoroquinolone-resistant RR/MDR-TB']}, {'name': 'BPaL', 'type': 'DRUG', 'otherNames': ['Bedaquiline, Pretomanid, Linezolid'], 'description': 'Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks', 'armGroupLabels': ['BPaL for Fluoroquinolone-resistant RR/MDR-TB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101100', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Capital Medical University - Beijing Chest Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '518112', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The Third People's Hospital of Shenzhen", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '430032', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210003', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The Second Hospital of Nanjing', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Huashan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital - Pneumology', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Public Health Clinical Center of Chengdu', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '0101', 'city': 'Tbilisi', 'status': 'NOT_YET_RECRUITING', 'country': 'Georgia', 'facility': 'National Center for Tuberculosis and Lung Disease', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '204-8522', 'city': 'Kiyose', 'state': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Japan Anti-Tuberculosis Association Fukujuji Hospital', 'geoPoint': {'lat': 35.77952, 'lon': 139.53014}}, {'zip': 'MD-2025', 'city': 'Chisinau', 'state': 'Chisinau City', 'status': 'RECRUITING', 'country': 'Moldova', 'facility': 'IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '15012', 'city': 'La Molina', 'state': 'Lima region', 'status': 'NOT_YET_RECRUITING', 'country': 'Peru', 'facility': 'Socios en Salud Sucursal Peru', 'geoPoint': {'lat': -12.08333, 'lon': -76.95}}, {'zip': '15837', 'city': 'Villa El Salvador', 'state': 'Lima region', 'status': 'NOT_YET_RECRUITING', 'country': 'Peru', 'facility': 'Centro de Investigación del Hospital de Emergencias de Villa el Salvador', 'geoPoint': {'lat': -12.19852, 'lon': -76.94483}}, {'zip': '15313', 'city': 'Lima', 'status': 'NOT_YET_RECRUITING', 'country': 'Peru', 'facility': 'Hospital Sergio E. Bernales', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '4118', 'city': 'Silang', 'state': 'Cavite', 'status': 'RECRUITING', 'country': 'Philippines', 'facility': 'Silang Specialist Medical Center', 'geoPoint': {'lat': 14.21567, 'lon': 120.97137}}, {'zip': '2000', 'city': 'San Fernando City', 'state': 'Central Luzon (Region III)', 'status': 'NOT_YET_RECRUITING', 'country': 'Philippines', 'facility': 'Jose B. Lingad Memorial Regional Hospital', 'geoPoint': {'lat': 15.03425, 'lon': 120.68445}}, {'zip': '1772', 'city': 'Makati City', 'state': 'National Capital Region', 'status': 'RECRUITING', 'country': 'Philippines', 'facility': 'Tropical Disease Foundation', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'zip': '1100', 'city': 'Quezon City', 'state': 'National Capital Region', 'status': 'NOT_YET_RECRUITING', 'country': 'Philippines', 'facility': 'Lung Center Of The Philippines', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '5241', 'city': 'East London', 'state': 'Eastern Cape', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Synergy Biomed Research Institute', 'geoPoint': {'lat': -33.01529, 'lon': 27.91162}}, {'zip': '6003', 'city': 'Port Elizabeth', 'state': 'Eastern Cape', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '1632', 'city': 'Johannesburg', 'state': 'Gauteng', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'The Aurum Institute - Tembisa Hospital Clinical Research Centre', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2092', 'city': 'Johannesburg', 'state': 'Gauteng', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2131', 'city': 'Johannesburg', 'state': 'Gauteng', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0152', 'city': 'Pretoria', 'state': 'Gauteng', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Setshaba Research Center', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4013', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA)', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Madibeng Centre for Research', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '2574', 'city': 'Klerksdorp', 'state': 'North West', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit', 'geoPoint': {'lat': -26.85213, 'lon': 26.66672}}, {'zip': '0299', 'city': 'Rustenburg', 'state': 'North West', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'The Aurum Institute - Rustenburg', 'geoPoint': {'lat': -25.66756, 'lon': 27.24208}}, {'zip': '7405', 'city': 'Belville', 'state': 'Western Cape', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'Brooklyn Chest Hospital', 'geoPoint': {'lat': -33.89404, 'lon': 18.63486}}, {'zip': '7700', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'UCT - Lung Infection and Immunity Unit', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7700', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'NOT_YET_RECRUITING', 'country': 'South Africa', 'facility': 'UCT Lung Institute', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '21431', 'city': 'Incheon', 'state': 'Incheon Metropolitan City', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Incheon St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '49241', 'city': 'Busan', 'state': 'Pusan-Kwangyokshi', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital - Pulmonology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center - Pulmonology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Simbarashe G Takuva, MD, MSc.', 'role': 'CONTACT', 'email': 'stakuva@otsuka-onpg.com', 'phone': '+49 1737 820 292'}], 'overallOfficials': [{'name': 'Simbarashe G Takuva, MD, MSc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Sponsor'}]}, 'ipdSharingStatementModule': {'url': 'https://clinical-trials.otsuka.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.', 'ipdSharing': 'YES', 'description': 'Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.', 'accessCriteria': 'Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}