Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Effectiveness and Cardiac Safety of Bedaquiline-Based Therapy for Drug-Resistant Tuberculosis: A Prospective Cohort Study.
Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Efficacy and safety of treatment regimens for drug-resistant tuberculosis in different regions: a systematic review and meta-analysis.BMC infectious diseases · 2026Pooled it
- Prevalence of bedaquiline resistance in patients with drug-resistant tuberculosis: a systematic review and meta-analysis.BMC infectious diseases · 2025Pooled it
- The Safety and Tolerability of Linezolid in Novel Short-Course Regimens Containing Bedaquiline, Pretomanid, and Linezolid to Treat Rifampicin-Resistant Tuberculosis: An Individual Patient Data Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Pooled it
- Establishing the Exposure-QT Relationship During Bedaquiline Treatment Using a Time-Varying Tuberculosis-Specific Correction Factor (QTcTBT).CPT: pharmacometrics & systems pharmacology · 2025Trial
- How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial.Antimicrobial agents and chemotherapy · 2024Trial
- Effectiveness of Bedaquiline Use beyond Six Months in Patients with Multidrug-Resistant Tuberculosis.American journal of respiratory and critical care medicine · 2023Trial
- Linezolid Population Pharmacokinetics in South African Adults with Drug-Resistant Tuberculosis.Antimicrobial agents and chemotherapy · 2021Trial
- QT interval prolongation in patients receiving bedaquiline-based regimens for drug-resistant tuberculosis in Sub-Saharan Africa: A systematic review and meta-analysis.Journal of clinical tuberculosis and other mycobacterial diseases · 2026Article
- Bedaquiline Resistance in Drug-Resistant Tuberculosis in South Africa: A Systematic Review and Meta-Analysis of Emerging Trends.Antibiotics (Basel, Switzerland) · 2026Review
- Evaluating Treatment and Safety Outcomes of a Shorter Regimen for Drug-Resistant TB in Nigeria: An Implementation Research Study.Tropical medicine and infectious disease · 2026Article
- QT prolongation risk factors and a monitoring strategy in rifampicin-resistant tuberculosis: Findings from the STREAM Stage 2 trial.PLOS global public health · 2026Article
- Wild-type MIC distribution and evaluation of epidemiological cut-offs of second-line TB-drugs in susceptible and MDR-TB clinical isolates from Chennai, India.Frontiers in microbiology · 2026Article
- Treatment outcomes and associated influencing factors among elderly patients with rifampicin-resistant tuberculosis: a multicenter, retrospective, cohort study in China.BMC infectious diseases · 2025Article
- Real-world effectiveness and safety of prolonged bedaquiline course in the treatment of drug-resistant tuberculosis-a multi-center retrospective cohort study in a country with a high burden of drug-resistant tuberculosis.Microbiology spectrum · 2025Article
- Development and validation of a time-varying correction factor for QT interval assessment in drug-resistant tuberculosis patients.International journal of antimicrobial agents · 2025Article
- Updated treatment guidelines for drug-resistant TB: how safe are clofazimine-based regimens?IJTLD open · 2024Article
- Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings.JAMA network open · 2024Article
- Genotype-Phenotype Characterization of Serial Mycobacterium tuberculosis Isolates in Bedaquiline-Resistant Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- The effect of anti-tuberculosis drug pharmacokinetics on QTc prolongation.International journal of antimicrobial agents · 2023Observational
- Effects of Bedaquiline Combined with Fluoroquinolone and/or Clofazimine on QT Interval in Patients with Multidrug-Resistant Tuberculosis: a Retrospective Study.Microbiology spectrum · 2023Article
Corrections and comments
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Authors and funding
21 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundBedaquiline improves treatment outcomes in patients with rifampin-resistant (RR) tuberculosis but prolongs the QT interval and carries a black-box warning from the US Food and Drug Administration. The World Health Organization recommends that all patients with RR tuberculosis receive a regimen containing bedaquiline, yet a phase 3 clinical trial demonstrating its cardiac safety has not been published.
methodsWe conducted an observational cohort study of patients with RR tuberculosis from 3 provinces in South Africa who received regimens containing bedaquiline. We performed rigorous cardiac monitoring, which included obtaining electrocardiograms in triplicate at 4 time points during bedaquiline therapy. Participants were followed up until the end of therapy or 24 months. Outcomes included final tuberculosis treatment outcome and QT interval prolongation (QT prolongation), defined as any QT interval corrected by the Fridericia method (QTcF) >500 ms or an absolute change from baseline (ΔQTcF) >60 ms.
resultsWe enrolled 195 eligible participants, of whom 40% had extensively drug-resistant tuberculosis. Most participants (97%) received concurrent clofazimine. Of the participants, 74% were cured or successfully completed treatment, and outcomes did not differ by human immunodeficiency virus status. QTcF continued to increase throughout bedaquiline therapy, with a mean increase (standard deviation) of 23.7 (22.7) ms from baseline to month 6. Four participants experienced a QTcF >500 ms and 19 experienced a ΔQTcF >60 ms. Older age was independently associated with QT prolongation. QT prolongation was neither more common nor more severe in participants receiving concurrent lopinavir-ritonavir.
conclusionsSevere QT prolongation was uncommon and did not require permanent discontinuation of either bedaquiline or clofazimine. Close monitoring of the QT interval may be advisable in older patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.