دورية أكاديمية
أعرض في EDS

Efficacy and safety of an innovative short-course regimen containing clofazimine for treatment of drug-susceptible tuberculosis: a clinical trial.

التفاصيل البيبلوغرافية
العنوان: Efficacy and safety of an innovative short-course regimen containing clofazimine for treatment of drug-susceptible tuberculosis: a clinical trial.
المؤلفون: Zheng X; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Gui X; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Yao L; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Ma J; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., He Y; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Lou H; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Gu J; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Ying R; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Chen L; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Sun Q; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Liu Y; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Ho CM; Department of Mechanical and Aerospace Engineering, University of California, Los Angeles, CA, USA.; Department of Bioengineering, University of California, Los Angeles, CA, USA., Lee BY; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA., Clemens DL; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA., Horwitz MA; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, CA, USA., Ding X; Institute for Personalized Medicine, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, People's Republic of China., Hao X; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Yang H; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China., Sha W; Clinic and Research Centre of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People's Republic of China.
المصدر: Emerging microbes & infections [Emerg Microbes Infect] 2023 Dec; Vol. 12 (1), pp. 2187247.
نوع المنشور: Randomized Controlled Trial; Journal Article
اللغة: English
بيانات الدورية: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101594885 Publication Model: Print Cited Medium: Internet ISSN: 2222-1751 (Electronic) Linking ISSN: 22221751 NLM ISO Abbreviation: Emerg Microbes Infect Subsets: MEDLINE
أسماء مطبوعة: Publication: 2019- : [Philadelphia, PA] : Taylor & Francis
Original Publication: New York : NPG, 2012-2018.
مواضيع طبية MeSH: Clofazimine*/adverse effects , Tuberculosis*/drug therapy, Humans ; Prothionamide ; Drug Therapy, Combination ; Antitubercular Agents/adverse effects ; Pyrazinamide/adverse effects ; Treatment Outcome ; Isoniazid
مستخلص: In preclinical studies, a new antituberculosis drug regimen markedly reduced the time required to achieve relapse-free cure. This study aimed to preliminarily evaluate the efficacy and safety of this four-month regimen, consisting of clofazimine, prothionamide, pyrazinamide and ethambutol, with a standard six-month regimen in patients with drug-susceptible tuberculosis. An open-label pilot randomized clinical trial was conducted among the patients with newly diagnosed bacteriologically-confirmed pulmonary tuberculosis. The primary efficacy end-point was sputum culture negative conversion. Totally, 93 patients were included in the modified intention-to-treat population. The rates of sputum culture conversion were 65.2% (30/46) and 87.2% (41/47) for short-course and standard regimen group, respectively. There was no difference on two-month culture conversion rates, time to culture conversion, nor early bactericidal activity ( P  > 0.05). However, patients on short-course regimen were observed with lower rates of radiological improvement or recovery and sustained treatment success, which was mainly attributed to higher percent of patients permanently changed assigned regimen (32.1% vs. 12.3%, P  = 0.012). The main cause for it was drug-induced hepatitis (16/17). Although lowering the dose of prothionamide was approved, the alternative option of changing assigned regimen was chosen in this study. While in per-protocol population, sputum culture conversion rates were 87.0% (20/23) and 94.4% (34/36) for the respective groups. Overall, the short-course regimen appeared to have inferior efficacy and higher incidence of hepatitis but desired efficacy in per-protocol population. It provides the first proof-of-concept in humans of the capacity of the short-course approach to identify drug regimens that can shorten the treatment time for tuberculosis.
References: Eur Respir J. 2022 May 19;59(5):. (PMID: 35589114)
N Engl J Med. 2021 May 6;384(18):1705-1718. (PMID: 33951360)
J Antimicrob Chemother. 2017 Feb;72(2):455-461. (PMID: 27798204)
J Clin Microbiol. 2010 Jan;48(1):300-1. (PMID: 19923479)
Drugs. 2014 Jun;74(8):839-54. (PMID: 24846578)
Antimicrob Agents Chemother. 2019 May 24;63(6):. (PMID: 30936097)
Nat Commun. 2017 Jan 24;8:14183. (PMID: 28117835)
Antimicrob Agents Chemother. 2015;59(6):3042-51. (PMID: 25753644)
Hepatology. 2004 Feb;39(2):574-8. (PMID: 14768020)
PLoS One. 2019 May 10;14(5):e0215607. (PMID: 31075149)
Cochrane Database Syst Rev. 2019 Dec 12;12:CD012918. (PMID: 31828771)
Lancet Respir Med. 2020 Apr;8(4):383-394. (PMID: 32192585)
PLoS One. 2018 Nov 14;13(11):e0207469. (PMID: 30427938)
Annu Rev Med. 2019 Jan 27;70:105-120. (PMID: 30403551)
J Clin Epidemiol. 2016 Sep;77:38-43. (PMID: 27262238)
J Med Microbiol. 2002 Jan;51(1):42-49. (PMID: 11800471)
Int J Nanomedicine. 2012;7:2281-92. (PMID: 22654513)
Trials. 2014 Nov 21;15:456. (PMID: 25416527)
Proc Natl Acad Sci U S A. 2016 Apr 12;113(15):E2172-9. (PMID: 27035987)
Eur Respir J. 2021 Aug 19;58(2):. (PMID: 34413124)
Proc Natl Acad Sci U S A. 2015 Jan 20;112(3):869-74. (PMID: 25561537)
فهرسة مساهمة: Keywords: Short-course treatment; clofazimine; parabolic response surface; pulmonary tuberculosis; randomized clinical trial
المشرفين على المادة: D959AE5USF (Clofazimine)
76YOO33643 (Prothionamide)
0 (Antitubercular Agents)
2KNI5N06TI (Pyrazinamide)
V83O1VOZ8L (Isoniazid)
تواريخ الأحداث: Date Created: 20230306 Date Completed: 20230321 Latest Revision: 20230322
رمز التحديث: 20230322
مُعرف محوري في PubMed: PMC10026740
DOI: 10.1080/22221751.2023.2187247
PMID: 36872899
قاعدة البيانات: MEDLINE
الوصف
تدمد:2222-1751
DOI:10.1080/22221751.2023.2187247