Trial reportThe New England journal of medicine2012
Delamanid for multidrug-resistant pulmonary tuberculosis.
Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 300 papers, 9 of them syntheses that pooled it.
What it found
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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.
A Multi Center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC 67683 in Patients With Pulmonary Sputum Culture-Positive, Multidrug-resistant Tuberculosis
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis
Who cites it
300 citing papers in PubMed, 9 syntheses or guidelines pooled it, 732 citations in OpenAlex.
- Effectiveness and Safety of Bedaquiline-Containing Modified Shorter Regimens for Multidrug- or Rifampicin-Resistant Tuberculosis: A Single-Arm Meta-Analysis.Pathogens (Basel, Switzerland) · 2026Pooled it
- Delamanid-containing regimens and multidrug-resistant tuberculosis: A systematic review and meta-analysis.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022Pooled it
- Systematic review of mutations associated with resistance to the new and repurposed Mycobacterium tuberculosis drugs bedaquiline, clofazimine, linezolid, delamanid and pretomanid.The Journal of antimicrobial chemotherapy · 2020Pooled it
- Drug-associated adverse events in the treatment of multidrug-resistant tuberculosis: an individual patient data meta-analysis.The Lancet. Respiratory medicine · 2020Pooled it
- Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis.The Cochrane database of systematic reviews · 2019Pooled it
- Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review.British journal of clinical pharmacology · 2019Pooled it
- Preventing the spread of multidrug-resistant tuberculosis and protecting contacts of infectious cases.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2017Pooled it
- Combined Use of Delamanid and Bedaquiline to Treat Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis: A Systematic Review.International journal of molecular sciences · 2017Pooled it
- Carbapenems to Treat Multidrug and Extensively Drug-Resistant Tuberculosis: A Systematic Review.International journal of molecular sciences · 2016Pooled it
- A novel antituberculosis agent exhibits potent clinical efficacy and good safety profile: an open-label, randomized-controlled, multicenter, phase 2a trial.Signal transduction and targeted therapy · 2025Trial
- A Prospective Cohort Study on the Usage, Safety, and Efficacy of Delamanid in Patients With Pulmonary Multidrug-Resistant Tuberculosis in South Korea.Open forum infectious diseases · 2025Trial
- Relative bioavailability of delamanid 50 mg tablets dispersed in water in healthy adult volunteers.British journal of clinical pharmacology · 2025Trial
- Safety, Tolerability, Pharmacokinetics, and Metabolism of Telacebec (Q203) for the Treatment of Tuberculosis: a Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 1B Trial.Antimicrobial agents and chemotherapy · 2023Trial
- Assessing Prolongation of the Corrected QT Interval with Bedaquiline and Delamanid Coadministration to Predict the Cardiac Safety of Simplified Dosing Regimens.Clinical pharmacology and therapeutics · 2022Trial
- Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial.Antimicrobial agents and chemotherapy · 2022Trial
- Bedaquiline for multidrug-resistant TB in paediatric patients.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021Trial
- Evaluation of six months sputum culture conversion as a surrogate endpoint in a multidrug resistant-tuberculosis trial.PloS one · 2018Trial
- Triplicate Sputum Cultures for Efficacy Evaluation of Novel Antituberculosis Regimens.American journal of respiratory and critical care medicine · 2017Trial
- Trial
- Defining the optimal dose of rifapentine for pulmonary tuberculosis: Exposure-response relations from two phase II clinical trials.Clinical pharmacology and therapeutics · 2017Trial
240 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
21 authors at 18 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDelamanid (OPC-67683), a nitro-dihydro-imidazooxazole derivative, is a new antituberculosis medication that inhibits mycolic acid synthesis and has shown potent in vitro and in vivo activity against drug-resistant strains of Mycobacterium tuberculosis.
methodsIn this randomized, placebo-controlled, multinational clinical trial, we assigned 481 patients (nearly all of whom were negative for the human immunodeficiency virus) with pulmonary multidrug-resistant tuberculosis to receive delamanid, at a dose of 100 mg twice daily (161 patients) or 200 mg twice daily (160 patients), or placebo (160 patients) for 2 months in combination with a background drug regimen developed according to World Health Organization guidelines. Sputum cultures were assessed weekly with the use of both liquid broth and solid medium; sputum-culture conversion was defined as a series of five or more consecutive cultures that were negative for growth of M. tuberculosis. The primary efficacy end point was the proportion of patients with sputum-culture conversion in liquid broth medium at 2 months.
resultsAmong patients who received a background drug regimen plus 100 mg of delamanid twice daily, 45.4% had sputum-culture conversion in liquid broth at 2 months, as compared with 29.6% of patients who received a background drug regimen plus placebo (P=0.008). Likewise, as compared with the placebo group, the group that received the background drug regimen plus 200 mg of delamanid twice daily had a higher proportion of patients with sputum-culture conversion (41.9%, P=0.04). The findings were similar with assessment of sputum-culture conversion in solid medium. Most adverse events were mild to moderate in severity and were evenly distributed across groups. Although no clinical events due to QT prolongation on electrocardiography were observed, QT prolongation was reported significantly more frequently in the groups that received delamanid.
conclusionsDelamanid was associated with an increase in sputum-culture conversion at 2 months among patients with multidrug-resistant tuberculosis. This finding suggests that delamanid could enhance treatment options for multidrug-resistant tuberculosis. (Funded by Otsuka Pharmaceutical Development and Commercialization; ClinicalTrials.gov number, NCT00685360.).
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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.