Pub Date : 2024-08-01Epub Date: 2024-06-27DOI: 10.1016/S1473-3099(24)00425-0
Udani Samarasekera
{"title":"40 years of Helicobacter pylori.","authors":"Udani Samarasekera","doi":"10.1016/S1473-3099(24)00425-0","DOIUrl":"10.1016/S1473-3099(24)00425-0","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141472032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-20DOI: 10.1016/S1473-3099(24)00377-3
Daryl Geers, Lennert Gommers, Ngoc H Tan, Susanne Bogers, Debbie van Baarle, Alba Grifoni, Alessandro Sette, Annemarie Boerma, Frederique Visscher, Mathilde Richard, Mathis Funk, Luca M Zaeck, P Hugo M van der Kuy, Bart L Haagmans, Marion Pg Koopmans, Corine H GeurtsvanKessel, Rory D de Vries
{"title":"Profiling the SARS-CoV-2-specific T-cell response.","authors":"Daryl Geers, Lennert Gommers, Ngoc H Tan, Susanne Bogers, Debbie van Baarle, Alba Grifoni, Alessandro Sette, Annemarie Boerma, Frederique Visscher, Mathilde Richard, Mathis Funk, Luca M Zaeck, P Hugo M van der Kuy, Bart L Haagmans, Marion Pg Koopmans, Corine H GeurtsvanKessel, Rory D de Vries","doi":"10.1016/S1473-3099(24)00377-3","DOIUrl":"10.1016/S1473-3099(24)00377-3","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141443610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01DOI: 10.1016/S1473-3099(24)00404-3
Ahmed H Fahal, Eiman Siddig Ahmed, Sahar Mubarak Bakhiet, Osama Elhadi Bakhiet, Lamis Ahmed Fahal, Abubakar Ahmed Mohamed, El Semani Widaa Mohamedelamin, Mustafa El Nour Bahar, Hadil Yassir Attalla, Emmanuel Edwar Siddig, Najwa A Mhmoud, Ahmed Mudawi Musa, Wendy W J van de Sande, Bruno Scherrer, Peelen Oyieko, Thaddaeus W Egondi, Kevin O Onyango, Katsura Hata, Wan-Yu Chu, Thomas P C Dorlo, Roger J Brüggemann, Borna A Nyaoke, Nathalie Strub-Wourgaft, Eduard E Zijlstra
Background: Eumycetoma is an implantation mycosis characterised by a large subcutaneous mass in the extremities commonly caused by the fungus Madurella mycetomatis. Despite the long duration of treatment, commonly a minimum of 12 months, treatment failure is frequent and can lead to amputation. We aimed to compare the efficacy of two doses of fosravuconazole, a synthetic antifungal designed for use in onychomycosis and repurposed for mycetoma, with standard-of-care itraconazole, both in combination with surgery.
Methods: This phase 2, randomised, double-blind, active-controlled, superiority trial was conducted in a single centre in Sudan. Patients with eumycetoma caused by M mycetomatis, who were aged 15 years or older, with a set lesion diameter (>2 cm and ≤16 cm) requiring surgery were included. There was a limit of 20 female patients in the initial enrolment, owing to preclinical toxicity concerns. Exclusion criteria included previous surgical or medical treatment for eumycetoma; presence of loco-regional lymphatic extension; osteomyelitis, or other bone involvement; pregnancy or lactation; severe concomitant diseases; a BMI under 16 kg/m2; contraindication to use of the study drugs; pre-existing liver disease; lymphatic extension; osteomyelitis; transaminase levels more than two times the laboratory's upper limit of normal, or elevated levels of alkaline phosphatase or bilirubin; or any history of hypersensitivity to any azole antifungal drug. Patients were randomly allocated in a 1:1:1 ratio to 300 mg fosravuconazole weekly for 12 months (group 1); 200 mg fosravuconazole weekly for 12 months (group 2); or 400 mg itraconazole daily for 12 months (group 3) using a random number list with non-disclosed fixed blocks of size 12, with equal allocation to each of the three arms within a block. To ensure masking between groups, placebo pills were used to disguise the difference in dosing schedules. All groups took pills twice daily with meals. In all groups, surgery was performed at 6 months. The primary outcome was complete cure at end of treatment at the month 12 visit, as evidenced by absence of mycetoma mass, sinuses, and discharge; normal ultrasonography or MRI examination of the eumycetoma site; and, if a mass was present, negative fungal culture from the former mycetoma site. The primary outcome was assessed in the modified intention-to-treat (mITT) population (all patients who received one or more treatment dose with one or more primary efficacy assessment). Safety was assessed in all patients who received one or more doses of the study drug. This study is registered with ClinicalTrials.gov (NCT03086226) and is complete.
Findings: Between May 9, 2017, and June 10, 2021, 104 patients were randomly allocated (34 in group 1 and 2, respectively, and 36 in group 3). 86 (83%) of 104 patients were male and 18 (17%) patients were female. After an unplanned second interim an
背景：真菌瘤（Eumycetoma）是一种种植性真菌病，其特征是四肢皮下出现巨大肿块，通常由真菌马杜雷拉霉菌引起。尽管治疗时间较长，通常至少需要 12 个月，但治疗失败的情况屡见不鲜，并可能导致截肢。我们的目的是比较两种剂量的福斯拉康唑与伊曲康唑的疗效，福斯拉康唑是一种合成抗真菌药，专为甲真菌病设计，并被重新用于霉菌瘤的治疗，两种药物均与手术相结合：这项二期随机、双盲、主动对照、优效性试验在苏丹的一个中心进行。纳入的患者均为霉形体引起的眼球瘤患者，年龄在15岁或15岁以上，病变直径在一定范围内（大于2厘米且小于16厘米），需要进行手术治疗。出于临床前毒性的考虑，首次招募的女性患者人数限制为 20 人。排除标准包括：曾接受过umycetoma手术或药物治疗；存在局部区域淋巴扩展；骨髓炎或其他骨骼受累；怀孕或哺乳期；严重并发症；体重指数低于16 kg/m2；研究药物禁忌症；已有肝病；淋巴管扩展；骨髓炎；转氨酶水平超过实验室正常值上限的两倍，或碱性磷酸酶或胆红素水平升高；或对任何唑类抗真菌药物有过敏史。患者按1:1:1的比例随机分配到每周300毫克福斯拉康唑（第1组）、每周200毫克福斯拉康唑（第2组）或每天400毫克伊曲康唑（第3组），为期12个月。为确保组间的掩蔽性，使用安慰剂药片来掩盖用药计划的差异。所有治疗组每天用药两次，随餐服用。所有组别均在 6 个月后进行手术。主要结果是在治疗结束后第12个月的检查中完全治愈，具体表现为无真菌瘤肿块、窦道和分泌物；真菌瘤部位的超声波或核磁共振检查正常；如果存在肿块，原真菌瘤部位的真菌培养阴性。主要疗效在改良意向性治疗（mITT）人群（所有接受过一次或多次治疗并进行过一次或多次主要疗效评估的患者）中进行评估。安全性在所有接受过一次或多次治疗的患者中进行评估。本研究已在ClinicalTrials.gov（NCT03086226）注册，研究结果完整：2017年5月9日至2021年6月10日期间，104名患者被随机分配（第1组和第2组分别有34人，第3组有36人）。104名患者中有86名（83%）为男性，18名（17%）为女性。在进行了计划外的第二次中期分析后，研究因无效而提前终止。在mITT人群中，第1组34例（95% CI 32-68）中有17例（50%）在12个月时完全治愈，第2组34例（47-80）中有22例（65%）完全治愈，第3组36例（58-88）中有27例（75%）完全治愈，两种剂量的福斯拉康唑疗效均不优于伊曲康唑（200毫克福斯拉康唑P=0-35，300毫克福斯拉康唑P=0-030）。83名患者共发生了205起治疗突发不良事件，2名患者发生了导致停药的严重不良事件，均与治疗无关：无论使用哪种剂量的福斯拉康唑治疗，其疗效都不优于伊曲康唑，而且两种剂量的疗效在数量上也较低。然而，福斯拉康唑没有出现新的安全信号，与相对昂贵且难以使用的伊曲康唑相比，福斯拉康唑的药片负担较轻，药物相互作用风险较低，这表明有必要进一步研究疗程更短、治愈率更高且无需手术的有效治疗方法：被忽视疾病药物倡议。
{"title":"Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial.","authors":"Ahmed H Fahal, Eiman Siddig Ahmed, Sahar Mubarak Bakhiet, Osama Elhadi Bakhiet, Lamis Ahmed Fahal, Abubakar Ahmed Mohamed, El Semani Widaa Mohamedelamin, Mustafa El Nour Bahar, Hadil Yassir Attalla, Emmanuel Edwar Siddig, Najwa A Mhmoud, Ahmed Mudawi Musa, Wendy W J van de Sande, Bruno Scherrer, Peelen Oyieko, Thaddaeus W Egondi, Kevin O Onyango, Katsura Hata, Wan-Yu Chu, Thomas P C Dorlo, Roger J Brüggemann, Borna A Nyaoke, Nathalie Strub-Wourgaft, Eduard E Zijlstra","doi":"10.1016/S1473-3099(24)00404-3","DOIUrl":"https://doi.org/10.1016/S1473-3099(24)00404-3","url":null,"abstract":"<p><strong>Background: </strong>Eumycetoma is an implantation mycosis characterised by a large subcutaneous mass in the extremities commonly caused by the fungus Madurella mycetomatis. Despite the long duration of treatment, commonly a minimum of 12 months, treatment failure is frequent and can lead to amputation. We aimed to compare the efficacy of two doses of fosravuconazole, a synthetic antifungal designed for use in onychomycosis and repurposed for mycetoma, with standard-of-care itraconazole, both in combination with surgery.</p><p><strong>Methods: </strong>This phase 2, randomised, double-blind, active-controlled, superiority trial was conducted in a single centre in Sudan. Patients with eumycetoma caused by M mycetomatis, who were aged 15 years or older, with a set lesion diameter (>2 cm and ≤16 cm) requiring surgery were included. There was a limit of 20 female patients in the initial enrolment, owing to preclinical toxicity concerns. Exclusion criteria included previous surgical or medical treatment for eumycetoma; presence of loco-regional lymphatic extension; osteomyelitis, or other bone involvement; pregnancy or lactation; severe concomitant diseases; a BMI under 16 kg/m<sup>2</sup>; contraindication to use of the study drugs; pre-existing liver disease; lymphatic extension; osteomyelitis; transaminase levels more than two times the laboratory's upper limit of normal, or elevated levels of alkaline phosphatase or bilirubin; or any history of hypersensitivity to any azole antifungal drug. Patients were randomly allocated in a 1:1:1 ratio to 300 mg fosravuconazole weekly for 12 months (group 1); 200 mg fosravuconazole weekly for 12 months (group 2); or 400 mg itraconazole daily for 12 months (group 3) using a random number list with non-disclosed fixed blocks of size 12, with equal allocation to each of the three arms within a block. To ensure masking between groups, placebo pills were used to disguise the difference in dosing schedules. All groups took pills twice daily with meals. In all groups, surgery was performed at 6 months. The primary outcome was complete cure at end of treatment at the month 12 visit, as evidenced by absence of mycetoma mass, sinuses, and discharge; normal ultrasonography or MRI examination of the eumycetoma site; and, if a mass was present, negative fungal culture from the former mycetoma site. The primary outcome was assessed in the modified intention-to-treat (mITT) population (all patients who received one or more treatment dose with one or more primary efficacy assessment). Safety was assessed in all patients who received one or more doses of the study drug. This study is registered with ClinicalTrials.gov (NCT03086226) and is complete.</p><p><strong>Findings: </strong>Between May 9, 2017, and June 10, 2021, 104 patients were randomly allocated (34 in group 1 and 2, respectively, and 36 in group 3). 86 (83%) of 104 patients were male and 18 (17%) patients were female. After an unplanned second interim an","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-06-27DOI: 10.1016/S1473-3099(24)00426-2
{"title":"Correction to Lancet Infect Dis 2024; published online Feb 9. https://doi.org/10.1016/S1473-3099(23)00731-4.","authors":"","doi":"10.1016/S1473-3099(24)00426-2","DOIUrl":"10.1016/S1473-3099(24)00426-2","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141472033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-09DOI: 10.1016/S1473-3099(24)00446-8
Alix Boisson-Walsh
{"title":"Escalating mpox epidemic in DR Congo.","authors":"Alix Boisson-Walsh","doi":"10.1016/S1473-3099(24)00446-8","DOIUrl":"10.1016/S1473-3099(24)00446-8","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141602046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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