Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region.
Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse-free cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among regions with high second line drug use and resistance is still limited.
The investigators propose an observational study under programmatic conditions to evaluate the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan, Uzbekistan.

开始日期2013-09-01

申办/合作机构

Medecins Sans Frontières (UK)

[+1]

NCT00042289

/ CompletedN/AIIT

Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.

开始日期2003-06-09

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT00000796

/ CompletedN/AIIT

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain.
Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.

开始日期-

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与硫酸卷曲霉素相关的临床结果

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100 项与硫酸卷曲霉素相关的转化医学

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100 项与硫酸卷曲霉素相关的专利（医药）

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679

项与硫酸卷曲霉素相关的文献（医药）

2025-04-09·JOURNAL OF CLINICAL MICROBIOLOGY

Nanopore sequencing for precise detection of Mycobacterium tuberculosis and drug resistance: a retrospective multicenter study in China

Article

作者: Liu, Ning ; Pang, Yu ; Yu, Shanshan ; Gao, Weiwei ; Zhu, Qingdong ; Gu, Hongcang ; Li, Liang ; Xie, Zhouhua ; Xu, Peisong ; Wang, Hua ; Li, Peibo ; Liu, Fuyou ; Li, Haoran ; Wang, Qian ; Sun, Jinhao ; Wang, Yunfei ; Zeng, Yi

ABSTRACT:

Tuberculosis (TB) management in endemic regions often grapples with resource constraints, including the scarcity of Mycobacterium tuberculosis ( M.tb ) culture laboratories. The emergence of M.tb strains with complex drug resistance profiles necessitates rapid and comprehensive drug susceptibility testing (DST) to guide patient treatment. However, traditional phenotypic DST (pDST) for M.tb is costly and time-consuming. In this study, we retrospectively enrolled 829 participants from six specialized TB treatment hospitals in China from September 2022 to July 2023. The diagnostic performance of TBseq test, a targeted-nanopore sequencing assay, was compared head-to-head with M.tb culture, acid-fast bacillus smear, quantitative polymerase chain reaction, and Xpert MTB/RIF Ultra by using clinical diagnosis as the reference standard. Subsequently, pDST for seven anti-TB drugs (rifampicin, isoniazid, ethambutol, streptomycin, levofloxacin, amikacin, and capreomycin) was performed. The resistance predictions provided by the TBseq test were compared with pDST results, which were used as a reference standard. The performance estimates of TBseq test were quantified through sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (AUC), providing a comprehensive assessment of its diagnostic accuracy. We found that TBseq test demonstrated significantly superior diagnostic performance for TB compared to other methods, achieving a sensitivity of 90.9% (95% CI: 88.9%–93.0%), specificity of 93.0% (95% CI: 97.2%–99.5%), and an AUC of 0.92 (95% CI: 0.876–0.963). TBseq test also exhibited robust predictive capabilities for drug resistance to the seven anti-TB drugs, with sensitivity and specificity consistently above 90% for all drugs. The AUC values ranged from 0.919 to 0.998, indicative of high diagnostic accuracy in forecasting drug resistance.

IMPORTANCE:

Our results show that TBseq test offers excellent identification performance for tuberculosis (TB), significantly outperforming Mycobacterium tuberculosis ( M.tb) culture, acid-fast bacillus (AFB) smear, qPCR, and Xpert MTB/RIF. Its diagnostic accuracy for anti-TB drug resistance is also superior, with sensitivity and specificity above 90% for all drugs tested. This method can be integrated into routine clinical diagnostic workflows, enabling early diagnosis and reporting of drug resistance simultaneously.

2025-03-01·LANCET INFECTIOUS DISEASES

Evaluating culture-free targeted next-generation sequencing for diagnosing drug-resistant tuberculosis: a multicentre clinical study of two end-to-end commercial workflows

Article

作者: Hoogland, Christine ; Tukvadze, Nestani ; Uplekar, Swapna ; Georghiou, Sophia B ; Joseph, Lavania ; Rodwell, Timothy C ; Kambli, Priti ; Laurent, Sacha ; De la Rossa, Andres ; Colman, Rebecca E ; Seifert, Marva ; Maghradze, Nino ; Omar, Shaheed V ; Rodrigues, Camilla ; Suresh, Anita

BACKGROUND:

Drug-resistant tuberculosis remains a major obstacle in ending the global tuberculosis epidemic. Deployment of molecular tools for comprehensive drug resistance profiling is imperative for successful detection and characterisation of tuberculosis drug resistance. We aimed to assess the diagnostic accuracy of a new class of molecular diagnostics for drug-resistant tuberculosis.

METHODS:

We conducted a prospective, cross-sectional, multicentre clinical evaluation of the performance of two targeted next-generation sequencing (tNGS) assays for drug-resistant tuberculosis at reference laboratories in three countries (Georgia, India, and South Africa) to assess diagnostic accuracy and index test failure rates. Eligible participants were aged 18 years or older, with molecularly confirmed pulmonary tuberculosis, and at risk for rifampicin-resistant tuberculosis. Sensitivity and specificity for both tNGS index tests (GenoScreen Deeplex Myc-TB and Oxford Nanopore Technologies [ONT] Tuberculosis Drug Resistance Test) were calculated for rifampicin, isoniazid, fluoroquinolones (moxifloxacin, levofloxacin), second line-injectables (amikacin, kanamycin, capreomycin), pyrazinamide, bedaquiline, linezolid, clofazimine, ethambutol, and streptomycin against a composite reference standard of phenotypic drug susceptibility testing and whole-genome sequencing.

FINDINGS:

Between April 1, 2021, and June 30, 2022, 832 individuals were invited to participate in the study, of whom 720 were included in the final analysis (212, 376, and 132 participants in Georgia, India, and South Africa, respectively). Of 720 clinical sediment samples evaluated, 658 (91%) and 684 (95%) produced complete or partial results on the GenoScreen and ONT tNGS workflows, respectively, with 593 (96%) and 603 (98%) of 616 smear-positive samples producing tNGS sequence data. Both workflows had sensitivities and specificities of more than 95% for rifampicin and isoniazid, and high accuracy for fluoroquinolones (sensitivity approximately ≥94%) and second line-injectables (sensitivity 80%) compared with the composite reference standard. Importantly, these assays also detected mutations associated with resistance to critical new and repurposed drugs (bedaquiline, linezolid) not currently detectable by any other WHO-recommended rapid diagnostics on the market. We note that the current format of assays have low sensitivity (≤50%) for linezolid and more work on mutations associated with drug resistance is needed.

INTERPRETATION:

This multicentre evaluation demonstrates that culture-free tNGS can provide accurate sequencing results for detection and characterisation of drug resistance from Mycobacterium tuberculosis clinical sediment samples for timely, comprehensive profiling of drug-resistant tuberculosis.

FUNDING:

Unitaid.

2025-03-01·APMIS

Evaluating the Efficacy of Capreomycin and Levofloxacin Combination Therapy in Multidrug‐Resistant Tuberculosis Patients

Article

作者: Ding, Guozheng ; Xu, Sheng

ABSTRACT:

Capreomycin (CMN) paired with levofloxacin (LEV) was tested in patients with multidrug‐resistant pulmonary tuberculosis (MDR‐PTB) for efficacy and immune function. The control group (40 cases) received conventional treatment and the observation group (40 cases) received CMN combined with LEV were established. Three months of intensification therapy and eighteen months of consolidation therapy were performed. The therapeutic effects (sputum negative conversion, lesion absorption, cavity shrinkage, and total effective rates), CD4+, CD8+, immunoglobulin A (IgA), IgM, IgG, interleukin‐6 (IL‐6), IL‐17, tumor necrosis factor‐α (TNF‐α), serum alkaline phosphatase (ALP), aspartate aminotransferase (ALT), and alanine aminotransferase (AST) were assessed. Adverse reactions were compared. After treatment, the observation group performed at a higher sputum negative conversion rate, lesion absorption rate, cavity shrinkage rate, and total effective rate than the control group; CD4+, IgA, IgM, IgG, and IL‐17 were increased and CD8+, IL‐6, and TNF‐α were decreased in both groups, and all of them were improved significantly in the observation group; ALP, ALT, and AST were elevated in both groups, but the differences between the observation and control groups were comparable. CMN combined with LEV is highly effective for MDR‐PTB patients, enhancing immune function and reducing inflammation while having minimal effects on liver function.

项与硫酸卷曲霉素相关的新闻（医药）

2023-07-27

·生物制品圈

盘点抗生素种类以及常用残留检测方法

抗生素，是指由微生物（包括细菌、真菌、放线菌属）或高等动植物在生活过程中所产生的具有抗病原体或其他活性的一类次级代谢产物，能干扰其他生活细胞发育功能的化学物质。抗生素等抗菌剂的抑菌或杀菌作用，主要是针对“细菌有而人（或其他动植物）没有”的机制进行杀伤，包含四大作用机理，即：抑制细菌细胞壁合成，增强细菌细胞膜通透性，干扰细菌蛋白质合成以及抑制细菌核酸复制转录。抗生素分类 01β-内酰胺类抗生素：青霉素类、头孢菌素类、β-内酰胺酶抑制药等02大环内酯类抗生素：红霉素、罗红霉素、阿奇霉素、克拉霉素等03氨基甙类抗生素：卡那霉素、链霉素、庆大霉素、依替米星等04四环素类抗生素：四环素、土霉素、强力霉素等 05林可霉素类抗生素：林可霉素和克林霉素 06氯霉素类抗生素：氯霉素和硫霉素 07喹诺酮类：氟哌酸、氧氟沙星、洛美沙星等“沙星” 08其他抗细菌的抗生素：去甲万古霉素、磷霉素、卷曲霉素、利福平等生物药中抗生素残留及检测方法目前抗生素的残留一般存在于疫苗类药物中，虽然抗生素不是疫苗中的必须成分，但在一些疫苗的制备过程中，为了防止细菌污染，需要添加一些抗生素。在最终成品前，还要尽量去除抗生素。我国在2010版以后的药典中均规定：疫苗中如果添加了抗生素，成品中所有抗生素累计残留量不得超过50ng/剂。抑菌圈测量法抑菌圈法又叫扩散法，是利用待测药物在琼脂平板中扩散使其周围的细菌生长受到抑制而形成透明圈，即抑菌圈。抑菌圈直径的大小是抗生素效价的直观体现，可以根据抑菌圈大小对抗生素的效价进行定性或定量的判定。抑菌圈法简单易行、成本低廉，是一种经典的检测方法，但此方法耗时较长，并且如果要降低人为判断结果的主观因素，需配备抑菌圈分析仪。液相色谱串联质谱法液相色谱串联质谱（LC-MS-MS）是继气质联用和液质联用以后发展起来的又一新型分离检测技术。其具有分离效率高、分析速度快、灵敏度高、易排除杂质干扰、定性定量精准等众多特点，非常适合于多组分快速检测。近年来，国内外众多学者也开始选用LC-MS-MS进行各种基质样品中抗生素的分析检测，灵敏度高，选择性和特异性较好，定性定量准确。但此方法需要配备相应质谱设备，操作复杂，且通量较低。酶联免疫吸附法酶联免疫吸附检测技术是一种基于抗原-抗体反应的测定方法，多用于测量蛋白质等大分子的检测，也适用于抗生素这种小分子物质。其原理是通过形成三明治结构（双抗夹心法）或竞争限量酶标抗体（竞争法）后，通过酶标记抗体与底物的显色反应，根据颜色的深浅（吸光度）进行定量检测。相较于前两种抗生素检测方法，该方法用时短，操作简便，定量准确且具有高通量等特点，非常适合抗生素的检测。君研生物抗生素类定量检测试剂盒君研生物自主研发的“抗生素类残留定量检测试剂盒”采用间接竞争ELISA法，可以快速，有效地检测样品中抗生素的残留量。卡那霉素定量检测试剂盒卡那霉素是氨基糖甙类抗生素，应用于动物疾病的治疗、菌株筛选以及细胞和基因治疗药物原料制备中，由于其具有神经毒性和肾脏毒性，损害第8对脑神经，导致前庭和耳蜗损伤。在动物食品、生物药品中的残留会影响人类健康，甚至引起过敏反应。欧美国家及我国均要求其限量使用。君研生物的卡那霉素定量检测试剂盒采用间接竞争ELISA方法，微孔条上预包被的偶联卡那霉素抗原与样品中残留的卡那霉素竞争结合酶标记的抗卡那霉素单克隆抗体，之后通过加入TMB底物显色，使用酶标仪检测吸光值，吸光值与样品中卡那霉素的含量成负相关。本试剂盒操作时间仅需一小时左右，试剂盒灵敏度为0.05ng/ml，线性范围为0.05ng/ml-5ng/ml。产品优势 | PRODECT ADVANTAGE性能指标 | PERFORMANCE INDEX验证数据 | VALIDATION DATA 庆大霉素定量检测试剂盒庆大霉素系从放线菌科单孢子属发酵培养液中提得，系碱性化合物，是常用的氨基糖苷类抗生素，广泛应用于培养基配制。在临床上主要用于治疗细菌感染。庆大霉素具有神经毒性、肾脏毒性以及耳毒性。其在动物食品、生物药品中的残留会影响人类健康，甚至引起过敏反应。欧美国家及我国均要求其限量使用。君研生物的庆大霉素定量检测试剂盒采用间接竞争ELISA方法，微孔条上预包被的庆大霉素抗原与样品中残留的庆大霉素竞争结合酶标庆大霉素单克隆抗体，之后加入酶标二抗，再通过加入TMB底物显色，使用酶标仪检测吸光值，吸光值与样品中庆大霉素的含量成负相关。本试剂盒操作时间仅需一小时左右，试剂盒灵敏度为0.1ng/mL，线性范围为0.1ng/mL-10ng/mL。产品优势 | PRODECT ADVANTAGE性能指标 | PERFORMANCE INDEX验证数据 | VALIDATION DATAEND君研产品推荐关于君研君研生物科技（山西）有限公司作为独立创新的研发、生产和销售一体型企业，专注于为生物医药产业提供符合国际标准的质量安全检测产品和服务。公司由海归科学家与业内资深专家领队，通过了产品设计开发、生产和服务全过程 ISO13485 体系认证，建设约3200 平米符合 cGMP 标准和 ISO 13485:2016 体系要求的研发生产基地，为国内抗体、疫苗、细胞基因治疗、核酸药物等领域生物药企以及CRO/CDMO、科研机构和监管机构提供了国际品质的产品和专业的技术服务。公司结合生物医药行业发展需求，已经覆盖包含工艺杂质残留、宿主细胞核酸及蛋白残留、含量测定、外源污染物、载体基因安全性分析等检测项目在内的 30 余种标准化检测产品，拥有专利类知识产权 10 余项。君研生物坚持生物原料中国造，以“专业技术服务人类健康”为理念，以打造中国品牌为己任，坚持持续创新的态度，为客户创造价值，为人类健康贡献力量。国医械华光认证证书联系方式CONTACT INFORMATIONCONTACTNFORMATIN销售电话15234188795技术支持18734150104/19503412257联系邮箱junyans21@163.com公司官网www.junyanbios.cn

疫苗

100 项与硫酸卷曲霉素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00135	硫酸卷曲霉素	J04AB30	DB00314

研发状态

批准上市

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适应症	国家/地区	公司	日期
肺结核	美国	Epic Pharma LLC	1971-06-02

未上市

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适应症	最高研发状态	国家/地区	公司	日期
感染	临床前	美国	Matinas BioPharma Holdings, Inc.	2014-12-31

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASN2018	N/A	慢性肾病	-	Capreomycin	餘遞選構壓醖願壓觸顧(網憲淵餘積衊淵積繭顧) = This case demonstrates a rapid, severe alteration of the GFR in a diabetic, normotensive patient with no evident proteinuria. The biopsy did not reveal kidney impairment from the DM. The literature reports few cases on nephrotoxicity from CPM. This study emphasizes the importance of strict controlling the GFR in patients on CPM, especially the elderly and those with comorbidities. 範鑰艱繭齋鹽鏇鏇簾蓋 (襯淵餘醖獵繭醖獵獵築 )	-	2018-10-23
				Rifampicin, Isoniazid, Pyrazinamide, Etambutol, Levofloxacin, Terizidone