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Protective Measures Taken in Residential Care Homes in England During the COVID-19 Pandemic. An Assessment of the Change in Mortality Rates Before and During the COVID-19 Pandemic Years. COVID-19大流行期间英格兰寄宿护理院采取的保护措施COVID-19大流行前和期间死亡率变化的评估。
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-26 DOI: 10.1007/s40121-025-01183-6
Michael Stedman, Samuel Kitching, Martin B Whyte, Adrian Heald
{"title":"Protective Measures Taken in Residential Care Homes in England During the COVID-19 Pandemic. An Assessment of the Change in Mortality Rates Before and During the COVID-19 Pandemic Years.","authors":"Michael Stedman, Samuel Kitching, Martin B Whyte, Adrian Heald","doi":"10.1007/s40121-025-01183-6","DOIUrl":"10.1007/s40121-025-01183-6","url":null,"abstract":"<p><strong>Introduction: </strong>Mortality rate increased in the period after 1 January 2020 because of the Sars-Cov-2 (coronavirus disease 2019, COVID-19) pandemic. A significant proportion of those deaths occurred within residential care homes who were mandated to put in place stringent preventative measures including vaccinations, regular testing and visitor restrictions, while maintaining access to front-line healthcare. Our question was, by how much did these measures mitigate this increase in mortality rate?</p><p><strong>Methods: </strong>The Office of National Statistics (ONS) annually publish deaths, by age and sex, for each small geographic entity - the lower layer super output area (LSOA). A baseline of national average deaths per population in 2017-2019, by age group and sex, was calculated. This was then applied to local populations to calculate values of expected deaths and, when divided by the actual deaths, to create a standardised mortality rate (SMR). The change in standardised mortality rate (CSMR) was calculated as % change in SMR 2020-2022 compared with SMR 2017-2019. Excess deaths were then calculated on the basis of the assumption that CSMR would be 0% without the pandemic. The link between LSOA social deprivation index of multiple deprivation (IMD) score and CSMR was established by simple linear regression for each age group. The Care Quality Commission publish annually a register of residential care homes (RCH) which includes the post code location, which can be linked to an LSOA, and the number of beds split according to nursing care (CH) or purely residential homes (RH). Linking presence of RCH beds in LSOAs to outcome was evaluated in two ways, (1) by the amount with no RCH beds plus three tertiles of RCH bed number as the percent of older population (≥ 65 years) and (2) by the type of beds, those with RH only, CH only, or both RH and CH. CSMR was calculated for each of these cohorts. As RCH are mostly occupied by people aged ≥ 80 years, to estimate the impact of restrictions in care homes compared with the general community, the difference in CSMR between LSOAs with 'no RCHs' and 'with RCH' with baseline 0% CSMR were used to calculate the change in excess deaths.</p><p><strong>Results: </strong>Overall CSMR was 8.4%, (age group < 40 years was 5.7%, 40-64 years 13.7%, 65-79 years 11.3%, and ≥ 80 years 5.9%). This reflected 128,385 excess deaths in 2020-2022 compared with 2017-2019 (by age group < 40 years, 2106; 40-64 years: 26,120; 65-79 years: 49,301; and ≥ 80 years: 50,857). Social disadvantage had the most effect on CSMR in the age 80+ years group; in this group, the lowest five deciles (50%) of LSOAs by IMD score had CSMR of 4.5%, with the CSMR then increasing linearly up to 16% in the top IMD decile. In the age group of 80+ years, the 22,357 LSOAS with 'no RCH' had CSMR of 10.0% (as a result of 35,791 excess deaths), while in the 10,484 LSOAs 'with RCH' the CSMR was 3.3%, as a result of 17,840 excess deaths. In ","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1649-1665"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk Factors for Hospital Readmission Following Outpatient Parenteral Antimicrobial Therapy (OPAT). 门诊静脉注射抗菌药物治疗(OPAT)后再入院的危险因素
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-03 DOI: 10.1007/s40121-025-01182-7
Melanie Yousif, Matthew Geriak, Logan Vasina, George Sakoulas
{"title":"Risk Factors for Hospital Readmission Following Outpatient Parenteral Antimicrobial Therapy (OPAT).","authors":"Melanie Yousif, Matthew Geriak, Logan Vasina, George Sakoulas","doi":"10.1007/s40121-025-01182-7","DOIUrl":"10.1007/s40121-025-01182-7","url":null,"abstract":"<p><strong>Introduction: </strong>A main goal of outpatient parenteral antibiotic therapy (OPAT) is to streamline patient care and minimize time spent in the inpatient hospital setting. The identification of characteristics of patients who return to the hospital after being discharged on OPAT may identify modifiable steps that can be taken to reduce risk of hospital readmission as a practice improvement strategy.</p><p><strong>Methods: </strong>We performed a retrospective analysis of adult patients prescribed OPAT for ≥ 14 days prescribed by infectious disease consultation for non-urinary tract infections (non-UTI). We compared characteristics including demographics, sites of infection, microbiology, and antimicrobial therapy prescribed.</p><p><strong>Results: </strong>Of 233 adult OPAT patients with non-UTI infections receiving ID consultation, 61 (26%) were readmitted to the hospital (60 days), of which 37 (60%) were due to treatment failure. Ceftriaxone once daily was the most prescribed antimicrobial therapy. Microbiology and infection sites were similar between the two groups. Obesity (body mass index, BMI > 30 kg/m<sup>2</sup>) was more frequent among readmitted patients versus those not readmitted (odds ratio 3.6, 95% confidence interval 1.9-6.5, p < 0.0001). Polymicrobial infections were significantly more frequent among the readmitted group compared with the non-readmitted group (odds ratio 3.2, 95% confidence interval 1.7-6.0, p = 0.0004).</p><p><strong>Conclusions: </strong>Patients with obesity may not be receiving sufficient antimicrobial exposure with standard antibiotic dosing regimens, particularly with ceftriaxone. Antibiotic dosing in patients with obesity requires further study and optimization, particularly with cephalosporins.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1989-1995"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of Continuous Renal Replacement Therapy with Polyacrylonitrile-Derived Filter on Caspofungin Concentration: A Retrospective Study. 聚丙烯腈衍生滤器持续肾脏替代治疗对卡泊芬素浓度影响的回顾性研究。
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-05 DOI: 10.1007/s40121-025-01191-6
Romain Arrestier, Claire Pressiat, Laura Bouabdallah, Paul Masi, Nicolas Mongardon, Anne Hulin, Armand Mekontso Dessap, Keyvan Razazi
{"title":"Impact of Continuous Renal Replacement Therapy with Polyacrylonitrile-Derived Filter on Caspofungin Concentration: A Retrospective Study.","authors":"Romain Arrestier, Claire Pressiat, Laura Bouabdallah, Paul Masi, Nicolas Mongardon, Anne Hulin, Armand Mekontso Dessap, Keyvan Razazi","doi":"10.1007/s40121-025-01191-6","DOIUrl":"10.1007/s40121-025-01191-6","url":null,"abstract":"<p><strong>Introduction: </strong>Caspofungin pharmacokinetics may be altered in critically ill patients. In vitro studies suggest significant drug adsorption with polyacrylonitrile (PAN) membranes during continuous renal replacement therapy (CRRT).</p><p><strong>Methods: </strong>This study retrospectively analyzed 66 plasma caspofungin concentrations (pCAS<sub>conc</sub>) from 35 ICU patients between 2021 and 2024, comparing those on PAN-CRRT (n = 19) versus those without (n = 47).</p><p><strong>Results: </strong>Caspofungin is mainly prescribed for candidemia (40%) and invasive Candida infections (25.7%). Median pCAS<sub>conc</sub> at 12 h was similar between groups, but at 18 and 24 h, it was significantly higher in the PAN-CRRT group [5.3 (4.1-6.9) vs. 3.3 (1.9-3.7) mg/L, p = 0.04 and 5.3 (3.9-5.8) vs. 3.1 (2.5-4.5) mg/L, p = 0.01, respectively]. ECMO use was more frequent in PAN-CRRT patients (75% vs. 21.7%, p = 0.01). Persistent candidemia occurred in three patients (one in PAN-CRRT, two in non-PAN-CRRT).</p><p><strong>Conclusion: </strong>This study found no evidence of caspofungin depletion with PAN-CRRT, warranting further research on clinical outcomes.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1997-2006"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of Metabolic Dysfunction-Associated Fatty Liver Disease of Varying Severity on Antiviral Treatment Outcomes and Clinical Prognosis in Patients with Chronic Hepatitis B: A Systematic Review and Meta-analysis. 不同严重程度的代谢功能障碍相关脂肪性肝病对慢性乙型肝炎患者抗病毒治疗结果和临床预后的影响:一项系统综述和荟萃分析
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-10 DOI: 10.1007/s40121-025-01189-0
Qianqian Zhu, Chengde Su, Mingdan Li, Yali Xu, Qian Liu, Ying Zhang, Xinyi Zhang, Qiuxiang Li, Huajun Wang, Yawen Luo, Ping Yang
{"title":"Impact of Metabolic Dysfunction-Associated Fatty Liver Disease of Varying Severity on Antiviral Treatment Outcomes and Clinical Prognosis in Patients with Chronic Hepatitis B: A Systematic Review and Meta-analysis.","authors":"Qianqian Zhu, Chengde Su, Mingdan Li, Yali Xu, Qian Liu, Ying Zhang, Xinyi Zhang, Qiuxiang Li, Huajun Wang, Yawen Luo, Ping Yang","doi":"10.1007/s40121-025-01189-0","DOIUrl":"10.1007/s40121-025-01189-0","url":null,"abstract":"<p><strong>Introduction: </strong>The coexistence of hepatitis B virus (HBV) infection and metabolic dysfunction-associated fatty liver disease (MAFLD) is becoming increasingly common. The bidirectional interaction between persistent HBV infection and lipotoxicity may influence the progression of the disease. However, to date, there has been a lack of meta-analyses that stratify this dual-disease population based on the severity of MAFLD.</p><p><strong>Methods: </strong>This study was conducted in accordance with the PRISMA guidelines. Relevant literature on chronic hepatitis B (CHB) coexisting with MAFLD, published in Chinese and English databases from inception to January 6, 2025, was systematically retrieved. A meta-analysis was performed to evaluate the impact of MAFLD of varying severity on the efficacy of antiviral therapy and clinical outcomes in patients with CHB.</p><p><strong>Results: </strong>A total of 24 studies were included, among which seven investigated the impact of MAFLD severity on antiviral treatment efficacy, and 17 explored the influence of MAFLD on clinical outcomes in CHB. The meta-analysis revealed the following: HBeAg seroclearance rate: For the mild MAFLD group versus the CHB-only group, the odds ratio (OR) was 0.62; for the moderate-to-severe MAFLD group versus the CHB-only group, OR = 0.37, indicating a more pronounced negative impact of moderate-to-severe MAFLD on HBeAg seroconversion. HBsAg seroclearance rate: For the mild MAFLD group versus the CHB-only group, OR = 0.43; for the moderate-to-severe MAFLD group versus the CHB-only group, OR = 0.20, further supporting the greater adverse effect of more severe MAFLD on HBsAg seroclearance. Incidence of hepatocellular carcinoma (HCC): For the CHB combined with MAFLD group versus the CHB-only group, OR = 1.77, demonstrating a markedly increased risk of HCC development in the CHB combined with MAFLD group compared to the CHB-only group.</p><p><strong>Conclusions: </strong>This study is the first to systematically examine the complex relationship between CHB and MAFLD from the perspective of hepatic steatosis severity stratification. CHB combined with moderate-to-severe MAFLD is associated with HBsAg/HBeAg seroclearance rate and the likelihood of achieving functional cure, suggesting that MAFLD may exert a potentially beneficial effect on antiviral therapy. However, MAFLD is also significantly associated with an increased risk of HCC, potentially accelerating hepatic carcinogenesis through lipotoxic pathways.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1599-1617"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Colistin Sulfate-Based Combination Therapy for Infections Caused by Carbapenem-Resistant Organisms in Intensive Care Units: A Multicenter, Prospective, Observational Clinical Trial. 以硫酸粘菌素为基础的联合治疗重症监护病房碳青霉烯耐药菌感染:一项多中心、前瞻性、观察性临床试验。
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-29 DOI: 10.1007/s40121-025-01176-5
Fan Zhang, Danyang Peng, Faming He, Ying Liu, Binbin Zang, Yanqiu Gao, Chao Qin, Suping Guo, Yawei Qi, Xisheng Zheng, Lin Guo, Tingting Zhao, Yue Jin, Rongqi Su, Juan Du, Jiazhan Pan, Bingyu Qin, Huanzhang Shao
{"title":"Colistin Sulfate-Based Combination Therapy for Infections Caused by Carbapenem-Resistant Organisms in Intensive Care Units: A Multicenter, Prospective, Observational Clinical Trial.","authors":"Fan Zhang, Danyang Peng, Faming He, Ying Liu, Binbin Zang, Yanqiu Gao, Chao Qin, Suping Guo, Yawei Qi, Xisheng Zheng, Lin Guo, Tingting Zhao, Yue Jin, Rongqi Su, Juan Du, Jiazhan Pan, Bingyu Qin, Huanzhang Shao","doi":"10.1007/s40121-025-01176-5","DOIUrl":"10.1007/s40121-025-01176-5","url":null,"abstract":"<p><strong>Introduction: </strong>With the rapid spread of carbapenem-resistant Gram-negative bacterial infections, polymyxins have reemerged as a critical \"salvage\" antibiotic option.</p><p><strong>Methods: </strong>This multicenter observational study assessed the effectiveness and safety of colistin sulfate-based treatment for carbapenem-resistant organism (CRO) infections in patients in intensive care across ten clinical sites in China. Clinical and microbiological responses, 28-day all-cause mortality, and associated risk factors were analyzed. Nephrotoxicity was assessed using Kidney Disease Improving Global Outcomes (KDIGO) criteria.</p><p><strong>Results: </strong>Of 240 critically ill adult patients with confirmed CRO infection, 91.3% had pulmonary infection, and 77.1% and 52.5% achieved clinical and microbiological response, respectively. Subgroup analyses showed associations between outcomes and patient age and colistin sulfate treatment duration. The 28-day all-cause mortality was 27.1%. Clinical response and mortality were significantly associated with Sequential Organ Failure Assessment (SOFA) score and colistin sulfate treatment duration. Analysis of the receiver operating characteristic (ROC) curve revealed that the thresholds for colistin treatment duration for predicting clinical response and survival were > 9.5 days (area under the curve [AUC] > 0.7). Nephrotoxicity was reported in 13.1% of patients not receiving continuous renal replacement therapy (CRRT), with no significant duration-dependent increase. Post-treatment serum creatinine (Scr) levels remained stable or improved across all renal function subgroups.</p><p><strong>Conclusions: </strong>Colistin sulfate in combination with other antimicrobials can be considered a reasonable and safe treatment option for CRO infections. Understanding the factors involved in this potential beneficial treatment can enable more careful follow-up of patients.</p><p><strong>Trial registration: </strong>ChiCTR, ChiCTR2100044866. Registered on 30 March 2021, https://www.chictr.org.cn/showproj.html?proj=124119 .</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1667-1684"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339826/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stability of Ceftobiprole Medocaril in Portable Elastomeric Infusion Devices. 头孢双prole Medocaril在便携式弹性体输液装置中的稳定性。
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-02 DOI: 10.1007/s40121-025-01174-7
Beatriz Esteban-Cartelle, Brayan J Anaya, Covadonga Pérez Menéndez-Conde, Noelia Vicente-Oliveros, Dolores R Serrano, Ana Álvarez-Díaz, Jesús Fortún-Abete, Pilar Martín-Dávila
{"title":"Stability of Ceftobiprole Medocaril in Portable Elastomeric Infusion Devices.","authors":"Beatriz Esteban-Cartelle, Brayan J Anaya, Covadonga Pérez Menéndez-Conde, Noelia Vicente-Oliveros, Dolores R Serrano, Ana Álvarez-Díaz, Jesús Fortún-Abete, Pilar Martín-Dávila","doi":"10.1007/s40121-025-01174-7","DOIUrl":"10.1007/s40121-025-01174-7","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Ceftobiprole medocaril is a new fifth-generation cephalosporin commercially available as a prodrug. Since it is newly introduced in therapy, there is limited data on its physicochemical stability for outpatient parenteral antimicrobial therapy (OPAT). This work aimed to demonstrate the suitability of ceftobiprole medocaril in OPAT, determining the physicochemical stability within portable elastomeric infusion devices (Accufuser C0100L 10 mL/h 300 mL).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Physicochemical stability was evaluated in 6.25 mg/mL solutions in sodium chloride 0.9% and dextrose 5% at three temperatures (2-8 °C, 25 °C, and 32 °C) using a previously validated liquid chromatography triple quadrupole mass spectrometry (LC-QQQ-MS) method. Drug adsorption onto device walls was also determined at the end of the study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Ceftobiprole medocaril remained above 95% of the initial concentration in sodium chloride 0.9% for up to 24 h at both refrigerated (2-8 °C) and ambient conditions (25 °C). Stability was reduced in dextrose 5% solutions. While pH increased slightly over time, it remained within acceptable limits for intravenous administration, and no particle formation was detected. Drug adsorption to the elastomeric device was negligible (&lt; 0.1%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Ceftobiprole medocaril is suitable for administration in OPAT at 6.25 mg/mL in sodium chloride 0.9% over 24 h at 25 °C using Accufuser&lt;sup&gt;®&lt;/sup&gt; portable elastomeric infusion devices. These findings support the development of practical administration protocols for ceftobiprole medocaril in home-based antimicrobial therapy. Ceftobiprole medocaril is a new antibiotic used to treat serious infections. Because it was recently introduced, there is limited information about its stability when used for outpatient parenteral antimicrobial therapy (OPAT), a treatment that allows patients to receive intravenous antibiotics at home using portable elastomeric infusion devices. This study examined how stable ceftobiprole medocaril remains when stored and administered in portable elastomeric infusion devices. The antibiotic was diluted in two commonly used fluids (saline and dextrose) and kept at different temperatures: refrigerated (2-8 °C), room temperature (25 °C), and body temperature (32 °C). Researchers measured how much of the drug remained active over 24 hours and whether it adhered to the inside of the device. The results showed that ceftobiprole medocaril in saline solution (sodium chloride 0.9%) remained stable for 24 hours at room temperature and when refrigerated, keeping over 95% of its original amount. In dextrose, the drug was less stable. The pH changed slightly, but no harmful particles formed, and less than 0.1% of the drug stuck to the infusion device, confirming that the device is suitable for this use. On the basis of these findings, ceftobiprole medocaril can be safely administered in saline solutio","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1685-1696"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring Human Use of Monoclonal Antibodies Against Critical Bacteria: A Scoping Review of Clinical Trials. 探索人类使用单克隆抗体对抗关键细菌:临床试验的范围综述。
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-25 DOI: 10.1007/s40121-025-01195-2
Marco Piscaglia, Giovanni Scaglione, Camilla Genovese, Fabio Borgonovo, Fabio Brivio, Flavia Rampichini, Renata Grifantini, Alessandra Bandera, Andrea Gori, Marta Colaneri, Emanuele Palomba
{"title":"Exploring Human Use of Monoclonal Antibodies Against Critical Bacteria: A Scoping Review of Clinical Trials.","authors":"Marco Piscaglia, Giovanni Scaglione, Camilla Genovese, Fabio Borgonovo, Fabio Brivio, Flavia Rampichini, Renata Grifantini, Alessandra Bandera, Andrea Gori, Marta Colaneri, Emanuele Palomba","doi":"10.1007/s40121-025-01195-2","DOIUrl":"10.1007/s40121-025-01195-2","url":null,"abstract":"<p><strong>Introduction: </strong>The global spread of multidrug-resistant organisms (MDROs), particularly the World Health Organization (WHO) priority pathogens, poses a major challenge to infection treatment, necessitating alternative therapeutic strategies. Monoclonal antibodies (mAbs) have emerged as a potential approach. This review evaluates the clinical efficacy, safety, and limitations of mAbs targeting critical bacterial pathogens, analyzing factors influencing therapeutic outcomes, and proposing strategies to optimize their clinical application.</p><p><strong>Methods: </strong>A comprehensive analysis of clinical trials investigating antibacterial mAbs was conducted. The review assessed key factors influencing therapeutic outcomes, including trial design, patient heterogeneity, and pharmacokinetics (PK). Comparative analysis was performed to examine differences in efficacy, safety, and limitations across studies. A structured risk of bias assessment was performed using Cochrane Methods' tools.</p><p><strong>Results: </strong>Owing to the low number of studies against MDROs, all trials about mAbs targeting Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA) were included, disregarding resistance profiles. Generally, clinical trials evaluating antibacterial mAbs have shown preliminary evidence. For PA, panobacumab exhibited a favorable safety profile but lacked clear clinical benefits, showing a good survival rate but in a small uncontrolled trial. Rivabazumab reduced bacterial colonization, but did not significantly lower pneumonia incidence. Gremubamab was well tolerated but failed to meet efficacy endpoints. For SA, tosatoxumab and suvratoxumab failed to show statistical significance but may have potential benefits for pneumonia, although phase III trials are needed.</p><p><strong>Conclusions: </strong>Inconsistent efficacy may stem from complex host-pathogen interactions, biofilm formation, and variations in patient immune status. Future trials should investigate early mAb administration, stratified patient selection, and standardized antibiotic coadministration, poorly addressed thus far. Optimized dosing and mAb combination regimens are promising yet unexplored paths, while high production costs and regulatory issues remain a significant barrier.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1619-1647"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144730184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advanced Liver Disease Events in People with HIV and Hepatitis B Virus Coinfection Initiating Antiretroviral Therapy in the United States. 在美国,HIV和乙型肝炎病毒合并感染患者开始抗逆转录病毒治疗的晚期肝病事件
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-15 DOI: 10.1007/s40121-025-01192-5
Ching-Yi Chuo, Woodie Zachry, Melanie de Boer, Laura Telep, Li Tao
{"title":"Advanced Liver Disease Events in People with HIV and Hepatitis B Virus Coinfection Initiating Antiretroviral Therapy in the United States.","authors":"Ching-Yi Chuo, Woodie Zachry, Melanie de Boer, Laura Telep, Li Tao","doi":"10.1007/s40121-025-01192-5","DOIUrl":"10.1007/s40121-025-01192-5","url":null,"abstract":"<p><strong>Introduction: </strong>HIV/hepatitis B virus (HBV) coinfection elevates the risk of liver-related complications compared to HIV or HBV mono-infections. While some antiretroviral therapy (ART) regimens slow liver disease progression, the long-term effects of tenofovir-based and non-tenofovir-based ART on advanced liver disease events in people with HIV/HBV remain unclear.</p><p><strong>Methods: </strong>People with HIV/HBV and aged ≥ 18 years or older who initiated ART between April 2016 and January 2024 were included from the US HealthVerity claims database. Advanced liver disease events (cirrhosis, liver decompensation, hepatocellular carcinoma [HCC], and liver transplant) were evaluated overall and individually among people who received tenofovir alafenamide (TAF)-based, tenofovir disoproxil fumarate (TDF)-based, or non-tenofovir-based ART; people with events prior to ART initiation were excluded. The time to advanced liver disease events were estimated with Kaplan-Meier methods. Adjusted hazard ratios and 95% CIs were calculated using Cox proportional hazards models. To evaluate liver function over time, alanine aminotransferase and aspartate aminotransferase levels before and after ART initiation were assessed for up to 1 year using adjusted mixed-effect models.</p><p><strong>Results: </strong>Among 3095 people included, 76% initiated TAF-based, 13% initiated TDF-based, and 11% initiated non-tenofovir-based ART. TAF-based and TDF-based ART had significantly longer times to any advanced liver disease event compared to non-tenofovir-based ART (log-rank P < 0.01). After adjustment, both TAF-based and TDF-based ART retained significantly reduced the risk of any advanced liver disease event and TAF-based ART had a lower risk of cirrhosis and risk of HCC compared with non-tenofovir-based ART (P < 0.05). Tenofovir-based ART was associated with stable liver enzyme levels over time.</p><p><strong>Conclusions: </strong>Tenofovir-based ART was associated with a reduced risk of severe liver-related complications overall. TAF-based ART was associated with progression to cirrhosis and HCC, relative to non-tenofovir-based ART in people with HIV/HBV. These findings highlight the importance of tenofovir-based ART regimens in improving outcomes for people with HIV/HBV.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1829-1842"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Syndemics of Antimicrobial Resistance: Non-communicable Diseases, Social Deprivation, and the Rise of Multidrug-Resistant Infections. 抗微生物药物耐药性综合症:非传染性疾病、社会剥夺和耐多药感染的增加。
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-03 DOI: 10.1007/s40121-025-01188-1
Jacinda C Abdul-Mutakabbir, Raheem Abdul-Mutakabbir
{"title":"Syndemics of Antimicrobial Resistance: Non-communicable Diseases, Social Deprivation, and the Rise of Multidrug-Resistant Infections.","authors":"Jacinda C Abdul-Mutakabbir, Raheem Abdul-Mutakabbir","doi":"10.1007/s40121-025-01188-1","DOIUrl":"10.1007/s40121-025-01188-1","url":null,"abstract":"<p><p>Antimicrobial resistance (AMR) constitutes a global health emergency that results in significant morbidity, mortality, and economic burden. Despite its severity, this issue remains inadequately addressed in public health discussions worldwide. This commentary employs a syndemic perspective to explore the synergistic relationship between multidrug-resistant (MDR) infections and non-communicable chronic diseases (NCDs). NCDs, including cardiovascular disease, chronic respiratory conditions, cancer, and diabetes mellitus, are prevalent among socially deprived populations, creating conditions that facilitate bacterial colonization and worsen disease severity, thus heightening the risk of infection and resulting in poorer clinical outcomes. Conversely, MDR infections can also exacerbate NCDs by provoking inflammatory responses and disrupting homeostasis. The commentary further underscores how social determinants of health (SDoH), such as economic hardship, limited access to healthcare, and lower educational attainment, intensify this syndemic relationship, particularly in low- and middle-income countries (LMICs) and among socially deprived populations in high-income countries. In conclusion, we provide actionable recommendations for clinicians to consider when identifying and addressing syndemics in AMR. Embracing a syndemic approach to combat AMR may yield more effective strategies to alleviate the AMR \"silent pandemic,\" especially benefiting populations disproportionately impacted by overlapping social, economic, and health vulnerabilities.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1561-1575"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of Hyperbaric Oxygen in Patients with Necrotizing Soft Tissue Infections: A Scandinavian Multicenter, Prospective, Observational Cohort. 使用高压氧治疗坏死性软组织感染患者:斯堪的纳维亚多中心前瞻性观察队列研究
IF 5.3 3区 医学
Infectious Diseases and Therapy Pub Date : 2025-08-01 Epub Date: 2025-07-04 DOI: 10.1007/s40121-025-01184-5
Ole Hyldegaard, Michael Nekludov, Per Arnell, Torbjørn Nedrebø, Ylva Karlsson, Martin Bruun Madsen, Steinar Skrede, Vitor Martins Dos Santos, Mattias Svensson, Anders Perner, Julie Vinkel, Anders Kjellberg, Anders Rosén, Johan Douglas, Trond Bruun, Christopher Hardt, Anna Norrby-Teglund, Morten Hedetoft
{"title":"Use of Hyperbaric Oxygen in Patients with Necrotizing Soft Tissue Infections: A Scandinavian Multicenter, Prospective, Observational Cohort.","authors":"Ole Hyldegaard, Michael Nekludov, Per Arnell, Torbjørn Nedrebø, Ylva Karlsson, Martin Bruun Madsen, Steinar Skrede, Vitor Martins Dos Santos, Mattias Svensson, Anders Perner, Julie Vinkel, Anders Kjellberg, Anders Rosén, Johan Douglas, Trond Bruun, Christopher Hardt, Anna Norrby-Teglund, Morten Hedetoft","doi":"10.1007/s40121-025-01184-5","DOIUrl":"10.1007/s40121-025-01184-5","url":null,"abstract":"<p><strong>Introduction: </strong>Hyperbaric oxygen (HBO<sub>2</sub>) treatment is regularly used as adjuvant treatment in patients with necrotizing soft tissue infections (NSTI). Several observational studies have suggested an association between hyperbaric oxygen (HBO<sub>2</sub>) treatment and improved survival in patients with necrotizing soft tissue infections (NSTIs); however, the evidence remains inconclusive. Most patients with NSTI are severely ill, having sepsis or septic shock, and requiring mechanical ventilation and inotropic support in an intensive care unit (ICU). Although recent data suggest that the beneficial effect of HBO<sub>2</sub> may be largest in the most severely ill, not all patients may receive it due to hemodynamic instability, pressure chamber capabilities, and availability, thereby potentially introducing selection bias.</p><p><strong>Methods: </strong>From January 2013 until June 2017, we conducted a multicenter, prospective, consecutive, observational study (The INFECT study, ClinicalTrials.gov number; NCT01790698) enrolling NSTI patients at five clinical centers delivering HBO<sub>2</sub> to NSTI patients in an ICU setting in Denmark, Norway, and Sweden.</p><p><strong>Results: </strong>A total of 409 consecutive patients with necrotizing soft tissue infections were prospectively enrolled in the study, of whom 402 (98.3%) were admitted to the ICU. A total of 329 NSTI patients received HBO<sub>2</sub>, and 80 patients did not. Median time from arrival at a specialized hospital to first HBO<sub>2</sub> was 4.3 h (IQR 2.5-7.7). Patients receiving HBO<sub>2</sub> had less often chronic liver disease, penetrating trauma within 4 weeks before NSTI, lower extremity NSTI involvement, and acute kidney injury and lower severity scores (Simplified Acute Physiology Score; SAPS-2 and Sequential Organ Failure Assessment score; SOFA score) than patients not treated with HBO<sub>2</sub>. Patients receiving HBO<sub>2</sub> were more frequently on mechanical ventilation. All-cause 30- and 90-day mortality for the HBO<sub>2</sub>-treated patients was 22/325 (7%) and 36/325 (11%) and for non-HBO<sub>2</sub>-treated patients 34/80 (43%) and 37/80 (46%). In exploratory analyses, HBO<sub>2</sub> was associated with lower all-cause 30-day mortality in unadjusted and in that adjusted for sex, lactate, SAPS-2, and baseline norepinephrine infusion rate.</p><p><strong>Conclusions: </strong>Patients receiving HBO<sub>2</sub> in this cohort were less acutely ill than those not receiving HBO<sub>2</sub> likely influencing physicians' decisions thereby introducing selection bias. In exploratory analyses, the use of HBO<sub>2</sub> was associated with a reduced 30-day all-cause mortality. A randomized trial of HBO<sub>2</sub> treatment seems warranted in patients with NSTI.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov number NCT01790698.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1715-1738"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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