A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB

Tweed, Conor; Wills, G; Crook, Angela M.; Amukoye, Evans; Balanag, Vincent M.; Ban, Andrea Yu-Lin; Bateson, Anna; Betteridge, Matthew C; Brumskine, William; Caoili, Janice Campos; Chaisson, Richard E.; Çevik, Müge; Conradie, Francesca; Dawson, Rodney; Parigi, Angelo Del; Diacon, Andreas H.; Everitt, Daniel E.; Fabiane, Stella M.; Hunt, Robert D.; Ismail, Ahmad Izuanuddin; Lalloo, Umesh; Lombard, Leandra; Louw, Cheryl; Malahleha, Mookho; McHugh, Timothy D.; Mendel, Carl M.; Mhimbira, Francis; Moodliar, Ronelle; Nduba, Videlis; Nunn, Andrew; Sabi, Issa; Sebe, Modulakgotla; Selepe, R. A. P.; Staples, Suzanne; Swindells, Susan; Niekerk, C.H. van; Variava, Ebrahim; Spigelman, Melvin; Gillespie, Stephen H.

doi:10.5588/ijtld.20.0513

Cited by 34 publications

(34 citation statements)

References 14 publications

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“…Adverse 176 events during two weeks of Pa-administration resulted in treatment interruptions in all treatment 177 groups in Diacon et al (2012b) and one patient on Pa-Bdq-Z in Diacon et al (2015). In Dawson et al 178 (2015) (26,33). 184…”

Section: Comparison Of Efficacy 169mentioning

confidence: 96%

“…Seven studies met inclusion criteria (Figure 1). Tweed et al (2021) was included in March 2021 (26).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Results related to 8-week bactericidal activity are presented in table 5 and table 6 (26,31,32). 137…”

Section: Bactericidal Activity After Eight Weeks Of Treatment 136mentioning

confidence: 99%

“…Tweed et al (2021) was interrupted due to safety concerns, remaining underpowered for its primary outcome. Per protocol analysis showed 73% (38/52) favourable outcomes in patients on 4Pa100-Mfx-Z, 81% (46/57) on 4Pa-Mfx-Z, 91% (43/47) on 6Pa-Mfx-Z and 98% (52/53) of controls (2HRZE/4HR).…”

mentioning

confidence: 99%

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Pretomanid for tuberculosis: a systematic review

Gils

Lynen

Jong

et al. 2022

Clinical Microbiology and Infection

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Comparison Of Efficacy 169mentioning

confidence: 96%

“…Seven studies met inclusion criteria (Figure 1). Tweed et al (2021) was included in March 2021 (26).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Results related to 8-week bactericidal activity are presented in table 5 and table 6 (26,31,32). 137…”

Section: Bactericidal Activity After Eight Weeks Of Treatment 136mentioning

confidence: 99%

mentioning

confidence: 99%

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Pretomanid for tuberculosis: a systematic review

Gils

Lynen

Jong

et al. 2022

Clinical Microbiology and Infection

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“…Overall, a higher rate of unfavorable outcomes for the primary measure compared with HRZE and failed non-inferiority criterion prompted early termination of the STAND trial. 78 …”

Section: Efficacy and Safetymentioning

confidence: 99%

Profiling Pretomanid as a Therapeutic Option for TB Infection: Evidence to Date

Stancil

Mirzayev

Abdel‐Rahman

2021

DDDT

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Tuberculosis (TB) is the most deadly infectious disease globally. Although most individuals achieve a cure, a substantial portion develop multi-drug resistant TB which is exceedingly difficult to treat, and the number of effective agents is dwindling. Development of new anti-tubercular medications is imperative to combat existing drug resistance and accelerate global eradication of TB. Pretomanid (PA-824) represents one of the newest drug classes (ie, nitroimidazooxazines) approved in 2019 by the United States Food and Drug Administration as part of a multi-drug regimen (with bedaquiline and linezolid, BPaL) and recommended by the World Health Organization (WHO) to treat extensively-resistant (XR-TB) and multi-drug resistant tuberculosis (MDR-TB). Approval was granted through the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, which accelerates approval for antimicrobial drugs used to treat life-threatening or serious infections in a limited population with unmet need. This review details the pharmacology, efficacy, and safety of this new agent and describes evidence to date for its role in the treatment of drug resistant TB including published, ongoing, and planned studies.

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A systematic efficacy analysis of tuberculosis treatment with BPaL‐containing regimens using a multiscale modeling approach

Budak,

Via,

Weiner

et al. 2024

CPT Pharmacom & Syst Pharma

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Tuberculosis (TB) is a life‐threatening infectious disease. The standard treatment is up to 90% effective; however, it requires the administration of four antibiotics (isoniazid, rifampicin, pyrazinamide, and ethambutol [HRZE]) over long time periods. This harsh treatment process causes adherence issues for patients because of the long treatment times and a myriad of adverse effects. Therefore, the World Health Organization has focused goals of shortening standard treatment regimens for TB in their End TB Strategy efforts, which aim to reduce TB‐related deaths by 95% by 2035. For this purpose, many novel and promising combination antibiotics are being explored that have recently been discovered, such as the bedaquiline, pretomanid, and linezolid (BPaL) regimen. As a result, testing the number of possible combinations with all possible novel regimens is beyond the limit of experimental resources. In this study, we present a unique framework that uses a primate granuloma modeling approach to screen many combination regimens that are currently under clinical and experimental exploration and assesses their efficacies to inform future studies. We tested well‐studied regimens such as HRZE and BPaL to evaluate the validity and accuracy of our framework. We also simulated additional promising combination regimens that have not been sufficiently studied clinically or experimentally, and we provide a pipeline for regimen ranking based on their efficacies in granulomas. Furthermore, we showed a correlation between simulation rankings and new marmoset data rankings, providing evidence for the credibility of our framework. This framework can be adapted to any TB regimen and can rank any number of single or combination regimens.

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A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB

Cited by 34 publications

References 14 publications

Pretomanid for tuberculosis: a systematic review

Pretomanid for tuberculosis: a systematic review

Profiling Pretomanid as a Therapeutic Option for TB Infection: Evidence to Date

A systematic efficacy analysis of tuberculosis treatment with BPaL‐containing regimens using a multiscale modeling approach

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