Multidrug-resistant Tuberculosis
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CLINICAL_TRIALS research · 2025-04-13Clinical Trial Update: Novel Triple-dose Tuberculosis Retreatment Regimen [Phase 3]
A Phase 3 clinical trial evaluating a novel triple-dose retreatment regimen for multidrug-resistant and pulmonary tuberculosis is currently …
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CLINICAL_TRIALS research · 2025-04-06Clinical Trial Update: Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB) [Phase 3]
Phase 3 INSPIRE-TB trial evaluating an all-oral, shorter, individualized regimen for rifampicin-resistant tuberculosis, including multidrug-…
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CLINICAL_TRIALS trial_result · 2025-03-21Clinical Trial Update: Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV [Phase 1, Phase 2]
The trial update summarizes pharmacokinetics, safety, and tolerability findings for bedaquiline in infants, children, and adolescents with m…
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CLINICAL_TRIALS trial_result · 2025-03-11Clinical Trial Update: Study of TB Lesions Obtained in Therapeutical Surgery
The clinical trial NCT02715271 investigating TB lesions obtained during therapeutical surgery has completed.
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CLINICAL_TRIALS trial_result · 2025-02-10Clinical Trial Update: Evaluating Newly Approved Drugs for Multidrug-resistant TB [Phase 3]
Phase 3 clinical trials evaluating newly approved drugs for multidrug-resistant tuberculosis have completed, according to a trial update.
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CLINICAL_TRIALS trial_result · 2025-02-03Clinical Trial Update: An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) [Phase 2]
An exploratory Phase 2 study of bedaquiline (TMC207) in Japanese patients with pulmonary multidrug-resistant tuberculosis has completed. The…
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CLINICAL_TRIALS trial_result · 2025-02-03Clinical Trial Update: Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB) [Phase 2]
Phase 2 clinical trial evaluating the early bactericidal activity of tedizolid and linezolid against tuberculosis, including multidrug-resis…
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CLINICAL_TRIALS trial_result · 2025-01-03Clinical Trial Update: Treatment Shortening of MDR-TB Using Existing and New Drugs [Phase 2]
Phase 2 trial evaluating shortening treatment for multidrug-resistant tuberculosis using existing and new drugs; the study is completed and …
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CLINICAL_TRIALS trial_result · 2024-12-03Clinical Trial Update: A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB [Phase 4]
A Phase 4 clinical trial completed evaluating Ultrashort PRS Regimen V for treating multidrug-resistant tuberculosis.
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FDA approval · 2024-11-22FDA Approved: PRETOMANID — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Pretomanid submitted by Viatris Specialty LLC, updating its labeling to reflect its use in drug-…
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CLINICAL_TRIALS trial_result · 2024-11-12Clinical Trial Update: Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T) [Phase 4]
A Phase 4 clinical trial update on refining regimens for ultra-short therapy in multidrug-resistant tuberculosis has been completed.
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CLINICAL_TRIALS trial_result · 2024-11-12Clinical Trial Update: Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS [NA]
A completed clinical trial evaluating refined ultra-short regimens for treating multidrug-resistant tuberculosis.
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CLINICAL_TRIALS research · 2024-11-05Clinical Trial Update: Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This is a clinical trial registry entry for the 9-month MDR-END treatment regimen for fluoroquinolone-sensitive multidrug-resistant tubercul…
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CLINICAL_TRIALS trial_result · 2024-11-04Clinical Trial Update: HIV and Multi-Drug Resistant Tuberculosis: a Study on Clinical Outcomes
This clinical trial update reports on a study evaluating clinical outcomes in people co-infected with HIV and multidrug-resistant tuberculos…
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CLINICAL_TRIALS research · 2024-10-24Clinical Trial Update: Hotspots, Households and Hospitals: Enhanced Drug-resistant Tuberculosis Case Finding in Namibia
A clinical trial in Namibia is recruiting to enhance case finding for drug-resistant tuberculosis through hotspots, households, and hospital…
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CLINICAL_TRIALS trial_result · 2024-10-08Clinical Trial Update: A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults [Phase 1]
Phase 1 study assessing drug-drug interaction of TB antibiotic candidate TBAJ-876 in healthy adults has completed with results posted.
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CLINICAL_TRIALS trial_result · 2024-09-19Clinical Trial Update: A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis [Phase 2]
Phase 2 trial evaluating the male reproductive safety of pretomanid in adult male participants with drug-resistant pulmonary tuberculosis; r…
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CLINICAL_TRIALS trial_result · 2024-08-28Clinical Trial Update: Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care [Phase 3]
Phase 3 trial evaluating a short-course regimen containing bedaquiline, delamanid, and linezolid versus the current standard of care for rif…
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CLINICAL_TRIALS trial_result · 2024-07-24Clinical Trial Update: Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid [Phase 1]
A Phase 1 single-dose study in healthy adults evaluating immediate-release and dispersible formulations of pretomanid to assess pharmacokine…
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FDA approval · 2024-06-21FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved Janssen's supplemental application for SIRTURO (bedaquiline fumarate), updating the labeling to reflect the approved changes.
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CLINICAL_TRIALS trial_result · 2024-05-29Clinical Trial Update: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
This clinical trial update reports on patient-reported experiences and quality-of-life outcomes from the TB-PRACTECAL trial evaluating treat…
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CLINICAL_TRIALS trial_result · 2024-05-16Clinical Trial Update: Tuberculosis Research of INA-RESPOND On Drug Resistance
The clinical trial update reports completion of the INA-RESPOND tuberculosis drug-resistance study, with results posted in May 2024. The stu…
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CLINICAL_TRIALS research · 2024-04-22Clinical Trial Update: Economic Evaluation of New MDR TB Regimens [Phase 2, Phase 3]
A clinical trial update evaluating the economic aspects of new regimens for multidrug-resistant and extensively drug-resistant tuberculosis …
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CLINICAL_TRIALS trial_result · 2023-11-08Clinical Trial Update: Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients [Phase 2, Phase 3]
Phase 2/3 trial assessing the efficacy, safety, and tolerability of BPaMZ in drug-sensitive and drug-resistant pulmonary tuberculosis; study…
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FDA approval · 2023-10-12FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP.