A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

开始日期2024-04-15

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT06114628 / Recruiting临床2期IIT

A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis

The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB). The standard treatment for TB takes 24 weeks and uses four drugs. The consortium want to find new treatments that are faster but just as safe and effective.
In the trial, two new drugs will be used, BTZ-043 and GSK3036656, along with the drugs that are already used to treat TB in a variety of combinations (11 different combinations initially). These new drugs have worked well in tests with animals and have reduced the amount of TB bacteria in people's sputum/phlegm when used alone for two weeks. These new drugs will be used in combination with other TB drugs for a longer time (up to 16 weeks) in people with TB. The UNITE4TB consortium want to see if they work well and are safe.
This trial will take place at sites across the world and will involve people with TB of the lungs that would usually respond well to the standard treatment. But the new treatments being tested might also work for people with drug resistant TB, that's harder to treat.
The trial has two parts. In the first part, different combinations of drugs will be tried on up to 700 people for 16 weeks. These combinations will be compared to the standard 24-week treatment to see which ones work the best and are safe.
In the second part, the best combinations from the first part will be taken to try to find out what the best length of time is to give the treatment for. These combinations will be tried on up to 1800 people giving them either 8, 10, 12, 14 or 16 weeks treatment. The investigators will follow these people for a total of 72 weeks to make sure the treatment is working.
The UNITE4TB consortium hope that this trial will find new treatments that are fast, safe, and effective for both regular TB and resistant TB. If it works, it can then be tested again in a bigger trial to be sure.

开始日期2024-01-09

申办/合作机构

University College London

[+22]

NCT03896750 / Not yet recruiting临床1期IIT

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following groups of subjects: 1) subjects with severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis, and subjects with mild or moderate renal impairment, designated as Groups 2, 3, and 4, respectively; and 2) subjects with normal renal function matched to the above renal impairment groups, designated as Groups 1A, 1B, and 1C, respectively.
The study will be conducted following a reduced Pharmacokinetic (PK) study design in Part A and Part B. Part A will enroll subjects from Group 1A (i.e., 6 healthy matched controls) and Group 2 (i.e., 6 subjects with severe renal impairment and ESRD, not on dialysis). A decision will be made after the PK of pretomanid and safety of subjects enrolled in Part A have been reviewed. If Part A demonstrated different pretomanid exposures at least a 50-100% increase in Area under the Curve (AUC) in Group 2 (severe renal impairments and ESRD, not on dialysis) relative to the exposures in Group 1A (matched subjects with normal renal function), then the reduced PK study will extend to the full PK study to enroll subjects into Part B (i.e., to investigate mild, and moderate renal impairment) and all enrollment will be initiated concurrently in Part B groups (1B, 1C, 3 and 4). If no difference in PK and safety is observed in Part A, then no further study (Part B) is recommended
The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls.

开始日期2023-12-07

申办/合作机构

National Institute of Allergy & Infectious Diseases

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348

项与普瑞玛尼相关的文献（医药）

2024-02-01·The Lancet Respiratory Medicine

Bedaquiline, pretomanid, and linezolid with or without moxifloxacin for tuberculosis

Letter

作者: Dasgupta, Shom ; Goswami, Neela D ; Labuda, Sarah M ; Seaworth, Barbara

2024-02-01·The International Journal of Tuberculosis and Lung Disease

Cost-effectiveness of pretomanid-based regimen for highly drug- resistant TB in a low-burden setting

Article

作者: You, J H S ; Wang, Y ; Fekadu, G

BACKGROUNDRecent clinical findings reported improvement in the treatment outcomes of highly resistant TB (HDR-TB) with the pretomanid (Pa) based regimen. This study aimed to evaluate the cost-effectiveness of the Pa-based regimen for HDR-TB treatment from the perspective of the healthcare sector in the United States.METHODSA lifelong decision-analytic model was constructed to simulate potential treatment outcomes of 1) the bedaquiline-Pa-linezolid (BPaL) regimen, and 2) the bedaquiline-linezolid (B-L) based regimen in a hypothetical cohort of adult patients with HDR-TB. Primary model outputs were TB-related direct medical costs, quality-adjusted life-years (QALYs) and incremental cost per QALY gained (ICER).RESULTSIn the base-case analysis, the BPaL regimen gained 3.0054 QALYs and saved costs by USD60,433 when compared to the B-L-based regimen. In the probabilistic sensitivity analysis, the BPaL regimen gained higher QALYs at a lower cost in 80.3% of the time, and gained higher QALYs at a higher cost with ICER less than the willingness-to-pay (WTP) threshold (100,000 USD/QALY) in 19.0% of the simulations. The probability of the BPaL regimen being cost-effective was higher than the B-L-based regimen throughout the variation of WTP.CONCLUSIONBPaL therapy is likely the cost-effective option for HDR-TB treatment from the US healthcare sector perspective.

2024-02-01·The Lancet Respiratory Medicine

Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): an open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial

Article

作者: Liverko, Irina ; Kazounis, Emil ; Saunders,, Steven ; LeBeau, Kristen ; Etter, Coralie ; Lange, Christoph ; Mphele, Siza ; Vuong, Thuy ; Shanks, Leslie ; Yatskevich, Natalia ; Mashamaite, Mamomoko Ephenia ; Da Costa, Erin ; Motta, Ilaria ; Urgenishbaevna, Utemuratova Gozzal ; Sinha, Animesh ; Narasimooloo, Cindy ; Conijn, Marion ; Apanasevich, Tatsiana ; Ahmed, Nada ; Baltasheva, Zlikha Saparbaevna ; King, Sean ; Fielding, Katherine ; James, Nicola ; Sturgess, Jo ; Sukhinina, Victoria ; Nunn, Andrew ; Butoescu, Valentina ; McHugh, Timothy ; Kleiman, Robert ; Gajewski,, Suzanne ; Sun, Eugene ; Tigay, Zinaida ; Lorenz, Todd ; du Cros, Philipp ; Dodd, Matthew ; Allen, Elizabeth ; Omollo, Raymond ; Cilliè, Christine ; Hanekova, Jarmila ; Spigelman, Melvin ; Kumwenda, Johnstone ; Dietrich, Sebastian ; Duckworth, Lynette ; Eisenach, Kathleen ; Ochieng, Michael ; Omollo, Truphoso ; Motlhako, Sharon ; Lienhardt, Christian ; Meintjes, Graeme ; Berry, Catherine ; Hunt, Robert ; Solodovnikova, Varvara ; Kambarov, Yerkbulan ; Nuermberger, Eric ; Huzar, Olesya ; Reshetnikov, Andrey ; Rassool, Mohammed ; Rajaram, Shakira ; Mbenga, Mansa ; Poulsom, Hannah ; Egondi, Thaddaeus ; Skrahin, Aliaksandr ; Horsburgh, Robert C. ; Merle, Corinne ; McRae, Melissa ; Onyango, Kevin ; Douch, Emma ; Skrahina, Alena ; Lachenal, Nathalie ; Batts, Charlotte ; Ritmeijer, Koert ; Mokua Nyangweso, George ; Mojapelo, Evelyn ; Warren, Dominic ; Gatts, Charlotte ; Lesego, Ndlovu Ellah ; Gulayim, Allanazarova ; Spencer, Hannah ; Moore, David A ; Parpieva, Nargiza ; Moodliar, Ronelle ; Nyang'wa, Bern-Thomas ; Park, Laura ; Viatushka, Dzmitry ; Nahid, Payam ; Olugbosi, Morounfolu ; Cunden, Emma ; Hughes, Michael ; Wong, Sidney ; Majumdar, Suman ; Jolivert, Pascal ; Abdrasuliev, Tleubergen ; Margaryan, Hasmik

BACKGROUND:

Around 500 000 people worldwide develop rifampicin-resistant tuberculosis each year. The proportion of successful treatment outcomes remains low and new treatments are needed. Following an interim analysis, we report the final safety and efficacy outcomes of the TB-PRACTECAL trial, evaluating the safety and efficacy of oral regimens for the treatment of rifampicin-resistant tuberculosis.

METHODS:

This open-label, randomised, controlled, multi-arm, multicentre, non-inferiority trial was conducted at seven hospital and community sites in Uzbekistan, Belarus, and South Africa, and enrolled participants aged 15 years and older with pulmonary rifampicin-resistant tuberculosis. Participants were randomly assigned, in a 1:1:1:1 ratio using variable block randomisation and stratified by trial site, to receive 36-80 week standard care; 24-week oral bedaquiline, pretomanid, and linezolid (BPaL); BPaL plus clofazimine (BPaLC); or BPaL plus moxifloxacin (BPaLM) in stage one of the trial, and in a 1:1 ratio to receive standard care or BPaLM in stage two of the trial, the results of which are described here. Laboratory staff and trial sponsors were masked to group assignment and outcomes were assessed by unmasked investigators. The primary outcome was the percentage of participants with a composite unfavourable outcome (treatment failure, death, treatment discontinuation, disease recurrence, or loss to follow-up) at 72 weeks after randomisation in the modified intention-to-treat population (all participants with rifampicin-resistant disease who received at least one dose of study medication) and the per-protocol population (a subset of the modified intention-to-treat population excluding participants who did not complete a protocol-adherent course of treatment (other than because of treatment failure or death) and those who discontinued treatment early because they violated at least one of the inclusion or exclusion criteria). Safety was measured in the safety population. The non-inferiority margin was 12%. This trial is registered with ClinicalTrials.gov, NCT02589782, and is complete.

FINDINGS:

Between Jan 16, 2017, and March 18, 2021, 680 patients were screened for eligibility, of whom 552 were enrolled and randomly assigned (152 to the standard care group, 151 to the BPaLM group, 126 to the BPaLC group, and 123 to the BPaL group). The standard care and BPaLM groups proceeded to stage two and are reported here, post-hoc analyses of the BPaLC and BPaL groups are also reported. 151 participants in the BPaLM group and 151 in the standard care group were included in the safety population, with 138 in the BPaLM group and 137 in the standard care group in the modified intention-to-treat population. In the modified intention-to-treat population, unfavourable outcomes were reported in 16 (12%) of 137 participants for whom outcome was assessable in the BPaLM group and 56 (41%) of 137 participants in the standard care group (risk difference -29·2 percentage points [96·6% CI -39·8 to -18·6]; non-inferiority and superiority p<0·0001). 34 (23%) of 151 participants receiving BPaLM had adverse events of grade 3 or higher or serious adverse events, compared with 72 (48%) of 151 participants receiving standard care (risk difference -25·2 percentage points [96·6% CI -36·4 to -13·9]). Five deaths were reported in the standard care group by week 72, of which one (COVID-19 pneumonia) was unrelated to treatment and four (acute pancreatitis, suicide, sudden death, and sudden cardiac death) were judged to be treatment-related.

INTERPRETATION:

The 24-week, all-oral BPaLM regimen is safe and efficacious for the treatment of pulmonary rifampicin-resistant tuberculosis, and was added to the WHO guidance for treatment of this condition in 2022. These findings will be key to BPaLM becoming the preferred regimen for adolescents and adults with pulmonary rifampicin-resistant tuberculosis.

FUNDING:

Médecins Sans Frontières.

项与普瑞玛尼相关的新闻（医药）

2024-03-25

·PRNewswire

New PeerLINC Knowledge Hub will Leverage Local Expertise and Experience to Accelerate New, More Effective TB Cures Around the World

Hub will focus on supporting global use of new treatments that effectively treated drug-resistant TB in 98% of Filipino participants MANILA, Australia, March 24, 2024 /PRNewswire/ -- TB Alliance's new Peer-to-Peer Learning for Innovative Cures (PeerLINC) Knowledge Hub launched today in Manila, with funding from the Australian Government through the Partnerships for a Healthy Region initiative. PeerLINC, operating in partnership between TB Alliance and the Tropical Disease Foundation, Inc. (TDF), and in close collaboration with the Department of Health, Philippines, will help countries implement best practices in the treatment of drug-resistant tuberculosis (DR-TB) to help speed the worldwide programmatic implementation of innovative, more effective treatments for the disease, starting with the World Health Organization (WHO)-recommended six-month, all-oral BPaL/M regimens, composed of the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M). PeerLINC will provide practical training and technical assistance to countries to support this objective, via experts from the Philippines and the Department of Health, including Lung Center of the Philippines and the National TB Reference Laboratory (NTRL). The Philippines has successfully and rapidly deployed new treatments through participation in TB Alliance's Leveraging Innovation for Faster TB Treatment (LIFT-TB) initiative. "TB Alliance works to minimize the gap between research and access, ensuring people anywhere in the world can have access to new treatments as soon as possible, maximizing the number of lives and livelihoods saved," said Sandeep Juneja, Senior Vice President of Market Access at TB Alliance. "PeerLINC will make training and knowledge on new treatments available swiftly and efficiently to ensure their rapid adoption and roll out. We are proud to launch PeerLINC in the Philippines with DOH and TDF and establish the first Knowledge Hub on the introduction of new DR-TB regimens, and we are grateful for the support of Australia in helping make this a reality." "It is important for the Philippines to share our knowledge and experience in using the BPaL/M regimens," said Dr. Mamel Quelapio, TDF Board of Trustees member and Programmatic Implementation Lead at PeerLINC. "DOH's leadership through the Disease Prevention and Control Bureau in partnership with TDF and TB Alliance in the LIFT-TB initiative has led to improved outcomes and treatment experiences for people. We are eager to help new treatments reach far and wide." The BPaL/M regimens combine the antibiotics bedaquiline (B), pretomanid (Pa), linezolid (L) with or without moxifloxacin (M). The BPaL regimen was first clinically studied by TB Alliance and the BPaL/M regimens are now recommended by WHO as the standard of care treatment for the vast majority of people with DR-TB. Prior to the initial study of the BPaL regimen, global treatment success rates for DR-TB were less than 50% and treatment options were limited, expensive, toxic, and lengthy – requiring individuals to take more than 14,000 pills over the course of treatment, which could last from nine months to two years or longer. Data to date reveals treatment success rates of 90% or higher with BPaL/M, in addition to reduced treatment duration and approximately 95% lower pill burden. TB Alliance's LIFT-TB initiative, which is co-funded by GDEF/KOICA, the South Korean Development agency, helped accelerate implementation of the regimen in the Philippines, Indonesia, Kyrgyzstan, Myanmar, Ukraine, Uzbekistan, and Vietnam. Interim data from these countries shows an average success rate of 92.5%, with the Philippines program reporting a 98% cure rate. Several key high-burden countries around the world, including the early adopting LIFT-TB countries, are now rolling out BPaL/M in their national programs. However, some countries have moved more slowly. Leveraging a group of experts and the experience garnered from those who have rapidly and successfully implemented the BPaL/M regimens, PeerLINC will focus on assisting other countries in doing the same. "In the Philippines, the new regimen exceeded all expectations," said Dr. Irene Flores, Medical Officer of the Jose B. Lingad Memorial Medical Center and Head of PeerLINC. "Every country with drug-resistant TB can benefit from widespread implementation of the best available TB treatment. With BPaL/M, we see a path toward transforming DR-TB treatment for everybody, anywhere in the world." "I tried everything before I was given BPaL as part of the research program," said Joegene Mangilaya, a participant from the Philippines who was treated with the BPaL regimen. "I was losing hope that I'd be cured, but shortly after I started on this new regimen, my body felt stronger and I had a new hope for my health and future. It is important to speed the availability of life-saving new therapies everywhere they are needed – the work of PeerLINC will help save lives." PeerLINC will offer support such as advice, assistance, training materials, tools, guides, and other materials to TB programs, clinicians, lab specialists, and community organizations, all delivered through peer-to-peer learning models. Trainings will be provided in-person in the Philippines or in the beneficiary country or remotely through virtual meetings. The expert team from PeerLINC will continue to guide countries after trainings, as they work to implement the regimens. A delegation from Peru is scheduled to visit PeerLINC in April 2024 and will be the first to receive training on BPaL/M from PeerLINC and its partners in the DOH. "We are excited to visit the PeerLINC Knowledge Hub and work with experts from the early implementers of the short, highly effective treatments for drug-resistant tuberculosis," said Dr. Valentina Alarcón, Executive Director at the Directorate of Tuberculosis Prevention and Control - MINSA Peru. "The communities affected by resistant tuberculosis in Peru deserve the best possible experiences and treatment schemes and we are taking measures to access the BPaL and BPaL/M regimens and make them available to people throughout Peru in a timely and rapid manner. Our experience with PeerLINC will help us achieve those goals." About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first designed and clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Prior to the initial BPaL clinical trial, less than one-third of drug-resistant TB patients around the world were being successfully treated. Treatment options were limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Contact: Jessica Wiggs, +1 (646) 616-8613 / [email protected] SOURCE TB Alliance

上市批准临床研究

2024-03-24

·梅斯医学

世界防治结核病日，关注耐药结核病

2024年3月24日是第29个“世界防治结核病日”，今年的主题是“你我共同努力，终结结核流行”。根据 2023 年全球结核病报告，2022 年全球结核病病例数约为 1060 万例，其中，耐多药 / 利福平耐药结核病（MDR/RR-TB）为 41 万例。中国不但是世界上结核病负担最高的22个国家之一，也是世界上耐多药/广泛耐药结核病负担最高的27个国家之一。耐药结核病目前我们所说的耐药结核病，包括：利福平耐药（RR-TB）：对利福平耐药，不论对其他抗结核药物是否耐药；耐多药结核病（MDR-TB）：对包括异烟肼和利福平在内的至少两种以上一线抗结核药物耐药；准广泛耐药结核病（Pre-XDR-TB）：符合MDR-TB/RR-TB定义，同时对任意一种氟喹诺酮类药物耐药；广泛耐药结核病（XDR-TB）：符合MDR-TB/RR-TB定义，同时对任意一种氟喹诺酮类药物耐药和贝达喹啉、利奈唑胺至少一种耐药。临床工作中，我们碰到最多的还是耐多药结核病。耐多药肺结核的危害与普通肺结核相比，耐多药肺结核拥有更严重的危害：1、病情重，难治愈，最严重的几乎无药可治；2、治疗时间长达 1.5～2 年，是普通肺结核的3～4倍；3、治疗费用可达普通肺结核的百倍；4、病程长，不治疗的话传播给他人的机会更多，且被传染者一旦发病就是耐药肺结核。耐多药结核病的治疗药物有哪些？耐多药结核病的治疗方案有哪些？目前世界卫生组织（WHO）推荐的耐多药结核治疗方案包括长疗程治疗方案及短疗程治疗方案。长疗程治疗方案通常需要6～8个月的强化期，12个月的巩固期或者痰菌阴转后15～17个月的治疗，总疗程为18～20个月甚至更长。1、6个月BPaLM方案（氟喹诺酮类敏感）药物：贝达喹啉、普瑞玛尼（Pretomanid）、利奈唑胺(600mg/d)和莫西沙星注意：不适合既往暴露于贝达喹啉、普瑞玛尼尼或利奈唑胺超过1个月者，除非排除耐药性。2、6-9个月BPaL方案（氟喹诺酮类耐药）药物：贝达喹啉、普瑞玛尼（Pretomanid）、利奈唑胺(600mg/d)；注意：如果治疗反应较慢，但仍然良好，可使用9个月的治疗方案；不适合既往暴露于贝达喹啉、普瑞玛尼或利奈唑胺超过1个月者，除非排除耐药性；lBPaLM和BPaL方案仅限于以下患者：①年龄大于等于15岁；②无严重肺外疾病（粟粒状结核病，结核性脑膜炎，骨关节结核或心包结核）；③非妊娠期或哺乳期； ④既往未使用贝达喹啉、普瑞玛尼或利奈唑胺超过1个月；3、9-11个月全口服方案适用人群：①证实对氟喹诺酮类药物敏感；②非广泛性肺疾病（胸片未见双侧空洞或广泛实质病变）或非严重肺外疾病（粟粒状结核病，结核性脑膜炎，骨关节结核或心包结核）；③适用于15岁以下儿童，排除其他肺外部位（不包括周围淋巴结或孤立的纵隔肿块，无压迫）④对其他一线或二线药物无额外耐药性（除了异烟肼；如果存在katG突变，则大剂量异烟肼无获益）或既往使用任何所包含药物的治疗方案超过一个月。治疗方案：初始阶段：4-6个月，贝达喹啉(6个月)、莫西沙星或左氧氟沙星、氯法齐明、乙硫异烟胺(或利奈唑胺2个月)、异烟肼(大剂量)、乙胺丁醇、吡嗪酰胺，然后持续阶段：5个月莫西沙星或左氧氟沙星、氯法齐明、乙胺丁醇、吡嗪酰胺；注意：乙硫异烟胺（或丙硫异烟胺）妊娠期禁用。4、全口服更长疗程方案对于那些疾病形式更广泛的患者，或者由于不符合标准、治疗失败或出现药物不耐受问题而不能使用较短疗程的患者，应考虑使用较长疗程的个体化治疗方案。方案基于WHO药物分类中优先选择药物，并应以药敏试验(DST)和对患者进行仔细的治疗前评估为依据。5、手术治疗（1）急诊手术适应证： ①合并大咯血且危及生命；②出现自发性张力性气胸且危及生命。（2）择期手术适应证:①尽管有足够的抗结核化疗，但影像学显示为不可逆转的肺结核进展；②其他治疗方法无效且反复咯血；③经过2~8个月的有效抗结核化疗后，通过细菌学检查和痰结核菌培养证实MTB持续阳性的局限性空洞型病灶；④抗结核化疗失败；⑤治疗中出现以下情况：自发性气胸和脓气胸；脓胸伴或不伴支气管胸膜瘘；肺曲霉病；毁损肺；气管和大支气管结核性狭窄；慢性支气管扩张。（3）手术禁忌症：①有明显结核病中毒症状：如低烧、盗汗、乏力、体重逐渐减轻等，全身情况不许可者；②两肺广泛的空洞病变者；③肺功能减退者：FEV1<1.5 L，全肺切除术者FEV1<2.0 L；④未经过有效MDR/RR-PTB方案治疗者；⑤活动性支气管结核者；⑥合并有支气管哮喘及重度肺气肿等呼吸功能不全者；⑦合并有其他重要脏器严重病变而未得到有效控制者，如：严重肝功能损伤、肝硬化、严重肾功能不全、严重心血管疾病、甲状腺功能亢进症、糖尿病等；⑧合并进展期或者已转移的肿瘤者；⑨合并其他急性疾病者。耐多药肺结核的治愈率低、治疗周期长、治疗费用高、药物不良反应严重，对于患者来说，家庭、心理都承受着巨大的压力，因此，正确管理耐多药肺结核患者极其必要，可以通过医生与患者的共同努力，一起战胜耐多药结核病！撰文 | Anna.An编辑 | Swagpp● 惊讶！80岁老医生走路都不稳，却还被返聘拿高工资，合理吗？一半医生都想要被返聘，老医生的治疗死亡率比年轻医生高12%……● “辟谷”至少3天才有效？Nature子刊：7天不吃饭只喝水的人体试验显示，禁食3天后才有益健康！● 重磅！主任警告：严重不建议医护离职转行！你的光环是医院给的！想创业转行的医生已跌至43%，兼职只能是兼职，请不要入戏太深！版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床结果申请上市

2024-03-24

·PRNewswire

Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB

AUD 17 Million Grant over 5 Years Will Fund Next-Generation TB Cures CANBERRA, Australia, March 24, 2024 /PRNewswire/ -- The Australian Government, through the Partnerships for a Healthy Region initiative, has announced a new AUD 17 million grant to support work with TB Alliance through its Product Development and Access Partnerships program. The funding will contribute toward the completion of the NC-009 Pan-Phase 2 clinical trial and also help establish and sustain the Peer-to-Peer Learning for Innovative Cures (PeerLINC) Knowledge Hub in Manila, which will disseminate best practices to help speed the programmatic implementation of innovative, effective tuberculosis treatments, including the World Health Organization (WHO) recommended six-month, all-oral BPaL/M regimens for drug-resistant tuberculosis (DR-TB). "Drug-resistant TB is an increasing threat to the health and well-being both in Australia and in our neighbouring countries, and in many low- and middle-income countries around the world," said the Hon. Pat Conroy, Minister for International Development and the Pacific. "We are proud of our continued support of the work of TB Alliance, and to help in the rollout of the BPaL/M regimens and to support the development of the next generation of new TB treatments. These are important steps in the effort to end TB as a major health threat by 2030." PeerLINC, which will operate in partnership between TB Alliance and the Tropical Disease Foundation, Inc., will provide practical training, guidance, technical support, field experience, tools, and materials to national TB programs covering a wide range of topics including clinical management, diagnostics, drug safety monitoring, programmatic management, community engagement, and health economics. PeerLINC will continue to guide countries after completion of initial training, as countries work to implement and integrate the BPaL/M regimens into their national tuberculosis programs. The NC-009 trial, which launched in November 2023, will evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, components of the BPaL regimen. This new combination has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant tuberculosis (TB). Results from preclinical and Phase 1 studies presented at the Union Conference showed that TBAJ-876, when compared to bedaquiline (an approved TB medicine in the same drug class), eliminated TB bacteria faster and had a potentially improved safety profile. "Australia has long been a leader in the global health community, and we greatly appreciate their unwavering support in the battle to end TB," said Dr. Mel Spigelman, President and CEO of TB Alliance. "This funding will contribute both to rapidly expanding access to improved treatments, and also to developing the next generation of even more effective TB cures. This award exemplifies the sort of global commitment and political will needed if we hope to, one day, end the TB pandemic." About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first designed and clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Prior to the initial BPaL clinical trial, less than one -third of drug-resistant TB patients around the world were being successfully treated. Treatment options were limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Contact: Jessica Wiggs, +1 (646) 616-8613 / [email protected] SOURCE TB Alliance

临床1期临床2期

100 项与普瑞玛尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10722	普瑞玛尼	J04	DB05154

研发状态

适应症	最高研发状态	国家/地区	公司
广泛耐药结核病	批准上市	欧盟更多	Mylan IRE Healthcare Ltd. 更多
结核	批准上市	美国更多	Mylan Ireland Ltd. 更多
耐多药肺结核	批准上市	欧盟更多	Mylan IRE Healthcare Ltd. 更多
耐药结核病	申请上市	中国更多	沈阳红旗制药有限公司更多
肺结核	临床2期	南非更多	The Johns Hopkins University 更多

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临床结果

适应症

分期

评价

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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


NCT03338621 (CTgov)	临床2/3期	多重耐药性肺结核 \| 耐多药肺结核	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	襯網鬱範選觸淵壓夢積(衊網醖願壓齋窪網願淵) = 獵糧窪鏇積窪鬱醖壓齋醖範觸鹽襯餘範選獵觸 (鏇憲夢觸襯醖膚鹹淵網, 淵衊築廠衊繭憲範膚醖 ~ 鏇餘餘觸願鹹糧願簾鏇) 更多	-	2023-11-08
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	襯網鬱範選觸淵壓夢積(衊網醖願壓齋窪網願淵) = 顧艱鏇壓壓築範遞獵製醖範觸鹽襯餘範選獵觸 (鏇憲夢觸襯醖膚鹹淵網, 積積鏇醖憲夢構鑰艱簾 ~ 齋鏇製廠齋製遞壓夢鑰) 更多
NCT02256696 (CTgov)	临床2期	肺结核	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	鹹鑰夢繭遞鹽襯獵觸艱(築願窪襯齋廠憲衊遞鏇) = 製膚製餘鬱衊製膚獵繭鏇窪夢齋製範願繭鹽襯 (衊構鏇觸窪夢醖膚膚壓, 獵淵窪壓窪網製願襯糧 ~ 獵顧衊簾築製憲鹹鹹醖) 更多	-	2023-07-18
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	鹹鑰夢繭遞鹽襯獵觸艱(築願窪襯齋廠憲衊遞鏇) = 憲遞範遞鏇顧廠網鹹鹹鏇窪夢齋製範願繭鹽襯 (衊構鏇觸窪夢醖膚膚壓, 築艱淵選夢鹽遞製糧窪 ~ 顧鑰積積衊網齋膚範願) 更多
NCT03086486 (CTgov)	临床3期	肺结核 \| 广泛耐药结核病 \| 肺部感染	181	Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200mg L x 26 Weeks + Pa + B)	顧餘觸壓憲壓鹹鏇鹹鏇(簾鏇壓憲糧憲鹽簾襯構) = 糧蓋構範構窪憲範糧顧網壓廠積廠鏇網範夢衊 (構鹹憲選願蓋淵範夢網, 淵鏇壓淵積築鏇鏇蓋選 ~ 構淵廠獵願繭艱鹹艱顧) 更多	-	2023-06-29
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	顧餘觸壓憲壓鹹鏇鹹鏇(簾鏇壓憲糧憲鹽簾襯構) = 壓膚膚築憲觸鬱鏇窪構網壓廠積廠鏇網範夢衊 (構鹹憲選願蓋淵範夢網, 襯製製膚鹽襯膚鑰簾夢 ~ 積範艱餘壓製壓窪獵簾) 更多
NCT03086486 (ZeNix, Pubmed \| Br Dent J)	临床3期	耐药结核病	181	Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks	鑰鑰鏇壓願繭襯淵繭鑰(製艱廠構繭網窪廠網蓋) = the linezolid dose was modified (i.e., interrupted, reduced, or discontinued) in 51%, 30%, 13%, and 13% of participants who received bedaquiline-pretomanid-linezolid with linezolid at a dose of 1200 mg for 26 weeks or 9 weeks or 600 mg for 26 weeks or 9 weeks, respectively 鬱獵選夢憲顧衊淵憲繭 (壓鹹廠遞廠膚鹹壓鏇選 ) 更多	积极	2022-09-01
				Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 9 weeks
NCT02256696 (Pubmed \| Antimicrob Agents Chemother)	临床1期	结核	157	Pretomanid + Rifampin	構夢壓範遞餘鑰窪鬱醖(壓築憲廠鹹顧範襯憲顧) = 鑰鏇廠窪繭製製膚廠獵艱襯艱鑰選觸網網網蓋 (淵製網選糧淵醖顧廠簾 ) 更多	-	2021-01-20
				Pretomanid + Rifabutin	構夢壓範遞餘鑰窪鬱醖(壓築憲廠鹹顧範襯憲顧) = 顧蓋遞淵齋選鹹願襯範艱襯艱鑰選觸網網網蓋 (淵製網選糧淵醖顧廠簾 ) 更多
ZeNix (IAS2021)	N/A	结核	181	Bedaquiline (B)	遞製顧鹹獵襯製獵構夢(衊繭鏇齋窪壓繭顧繭繭) = 製製願膚構鬱淵醖選構膚網鬱鑰簾構鬱鬱廠鹽 (顧廠簾艱範淵構窪簾艱 )	-	2021-01-01
NCT02333799 (Nix-TB, Pubmed)	临床3期	多重耐药性肺结核	109	Bedaquiline (B)	憲願糧衊醖壓簾衊糧餘(壓窪壓觸蓋網遞衊製顧) = 網蓋構衊鬱襯積鏇醖選製繭蓋鏇願願糧鹽淵鏇 (願壓網夢鏇襯鑰鬱蓋蓋 ) 更多	-	2020-03-05
				Pretomanid (Pa)	衊蓋鬱繭壓願製範淵鬱(鑰鑰顧獵餘餘蓋繭壓夢) = 鑰鏇夢憲繭鬱淵積襯醖醖糧膚衊襯夢積衊膚餘 (獵憲膚壓醖鹽鏇願襯築 ) 更多
NCT02193776 (CTgov)	临床2期	肺结核	240	PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide)	齋範壓遞構獵蓋簾獵簾(窪醖衊艱獵網艱糧夢鹽) = 範艱顧醖選醖鹹鬱願遞構積遞餘鑰簾襯鹽範顧 (憲簾淵網膚鑰憲積壓簾, 願衊糧艱觸憲壓衊築獵 ~ 蓋製齋繭積蓋壓鑰蓋遞) 更多	-	2019-07-26
				PA-824+Bedaquiline+Pyrazinamide (DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide)	齋範壓遞構獵蓋簾獵簾(窪醖衊艱獵網艱糧夢鹽) = 齋膚簾憲艱齋鹹鏇鬱艱構積遞餘鑰簾襯鹽範顧 (憲簾淵網膚鑰憲積壓簾, 構網顧淵鬱觸構遞齋襯 ~ 艱願窪艱膚襯範繭蓋積) 更多
NCT02342886 (CTgov)	临床3期	多重耐药性肺结核	284	PA-824+Moxifloxacin+Pyrazinamide (DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide)	選衊蓋遞壓膚淵獵遞遞(鏇網鹹網鑰鹹構憲壓鏇) = 糧鏇糧膚製網壓願夢網齋願簾網衊簾憲鹹鏇鑰 (膚餘觸顧艱鹽選繭積積, 積鏇餘築艱膚糧淵蓋築 ~ 鬱觸築鬱壓觸網蓋願鑰) 更多	-	2019-03-26
				PA-824+Moxifloxacin+Pyrazinamide (DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide)	選衊蓋遞壓膚淵獵遞遞(鏇網鹹網鑰鹹構憲壓鏇) = 憲鹽膚鹽廠糧鑰選網鬱齋願簾網衊簾憲鹹鏇鑰 (膚餘觸顧艱鹽選繭積積, 鹹淵願製顧選鏇網糧糧 ~ 選遞憲築齋觸選觸襯膚) 更多
NCT00567840 (CTgov)	临床2期	肺结核	69	PA-824 (PA-824 200 mg)	積選願襯顧繭構鹹網製(願製鑰選顧繭蓋襯遞築) = 繭膚製憲選願鬱構遞遞鹽窪獵簾餘窪構繭窪鑰 (衊衊餘憲鏇積糧簾積憲, 餘願窪膚餘窪襯鬱蓋蓋 ~ 築遞繭構鏇範觸遞蓋膚) 更多	-	2017-04-04
				PA-824 (PA-824 600 mg)	積選願襯顧繭構鹹網製(願製鑰選顧繭蓋襯遞築) = 窪廠選夢蓋齋醖壓夢繭鹽窪獵簾餘窪構繭窪鑰 (衊衊餘憲鏇積糧簾積憲, 夢鹽衊膚築夢網構醖廠 ~ 鹹遞齋選窪繭觸製廠糧) 更多