Infectious Diseases and Therapy最新文献

{"title":"Demonstrating Clinical Performance of the Elecsys Anti-SARS-CoV-2 Anti-Nucleocapsid Immunoassay Using Real-World Data to Support Regulatory Decision-Making in the USA.","authors":"Eldad A Hod, Baiyu Yang, Carsten Magnus, Christopher M Rank, Fei Yang, Annie Qiu, Joseph Lipschitz, Yona Feit, Alex J Rai, Elodie Baumfeld Andre","doi":"10.1007/s40121-026-01336-1","DOIUrl":"10.1007/s40121-026-01336-1","url":null,"abstract":"<p><strong>Introduction: </strong>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains a global public health concern. Anti-nucleocapsid (anti-N) serology is a key tool for identifying prior infection and supporting population-level surveillance. This study evaluated the clinical performance of the Elecsys^® Anti-SARS-CoV-2 Anti-N immunoassay on the Cobas^® e 601/602 immunoassay analyzer using real-world data from patients with polymerase chain reaction (PCR)-confirmed symptomatic SARS-CoV-2 infection. The study aimed to provide data which, along with clinical study data, supported the transition from Emergency Use Authorization of the assay to full clearance in the USA.</p><p><strong>Methods: </strong>We conducted a retrospective review of electronic medical records and laboratory information system data from patients who presented to Columbia University Irving Medical Center from March 2020 to March 2021. Eligible participants were symptomatic, unvaccinated individuals with PCR-confirmed SARS-CoV-2 infection who subsequently underwent serologic testing. Serologic results were categorized by days post symptom onset (DPSO): 0-7, 8-14, and ≥ 15 days. To avoid repeated measures, only the first serologic result per patient within each DPSO category was included. The primary endpoint was positive percent agreement (PPA) for nonimmunocompromised individuals tested at ≥ 15 DPSO, with a prespecified acceptance threshold of ≥ 90%.</p><p><strong>Results: </strong>A total of 585 serologic tests from 567 patients (77, 45, and 463 samples, in DPSO categories of 0-7, 8-14, and ≥ 15 days, respectively) were evaluated. Among nonimmunocompromised individuals with samples collected ≥ 15 DPSO (N = 285), the PPA was 96.49% (95% confidence interval 93.66%, 98.08%), fulfilling the predefined acceptance criterion. PPA was also consistent across demographic subgroups, supporting the generalizability of the findings.</p><p><strong>Conclusions: </strong>This study demonstrates the feasibility of generating robust clinical evidence for regulatory purposes using real-world data. The clinical performance of the Elecsys Anti-SARS-CoV-2 immunoassay was confirmed using data collected under routine conditions during the pandemic, complementing data from controlled clinical studies and contributing to informed regulatory decision-making.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1479-1491"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147618664","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}

{"title":"The Ongoing Challenge of Pertussis in Eastern and Northern Europe: Recommendations from the Global Pertussis Initiative.","authors":"Mine Durusu Tanriover, Ulrich Heininger, Ergin Çiftçi, Anca Cristina Drăgănescu, Andrzej Fal, Maria Tsolia, Dace Zavadska, Rodrigo Orozco Fernández, Daniela Flavia Hozbor, Donald B Middleton, Rudzani Muloiwa, Flor M Muñoz, Anna Ong-Lim, Tina Q Tan, Kevin Forsyth","doi":"10.1007/s40121-026-01329-0","DOIUrl":"10.1007/s40121-026-01329-0","url":null,"abstract":"<p><p>Pertussis (whooping cough), a vaccine-preventable disease that affects people of any age, has resurged globally after the COVID-19 pandemic. Key reasons for recent pertussis outbreaks include suboptimal pertussis vaccination coverage (particularly for vaccination during pregnancy) and growing vaccination hesitancy. During the 2023-2024 pertussis outbreaks in Europe, adolescents aged 10-14 years and 15-19 years had the first and third highest incidence rates, respectively. To reduce pertussis burden, it is essential to strengthen vaccination programs in the indicated target groups. This requires increased awareness among healthcare professionals about the local epidemiology of pertussis and its clinical presentation, alongside reinforcement of the benefits of vaccination for disease prevention. In parallel, robust surveillance systems and strong public health capacity for early disease detection and response are crucial to effectively manage outbreaks and build resilience against future outbreaks. Infants remain at high risk for pertussis, with complications, hospitalisation, and death being more common than in other age groups. Immunisation programmes combining vaccination during pregnancy, to protect newborn infants until their primary immunisation series has induced immunity, and infant immunisation are key to reducing morbidity and mortality. Strategies to improve pertussis vaccination uptake among adolescents and adults, especially those with high-risk medical conditions, are also essential. Strengthening global collaborations to invest in and build surveillance systems capable of identifying and responding to future outbreaks, to align national policies, to scale up immunisation during pregnancy, and to adopt a life-long immunisation approach are needed to better control endemic pertussis and manage future outbreaks.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1175-1201"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147592018","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}

{"title":"Antibiotic Pharmacokinetics and Prostate Penetration in Bacterial Prostatitis: A Systematic Review.","authors":"Rui Ge, Xinwen Nian, Benjuan Liu, Yunyun Yang, Zhuo Wang","doi":"10.1007/s40121-026-01341-4","DOIUrl":"10.1007/s40121-026-01341-4","url":null,"abstract":"<p><strong>Background: </strong>Effective treatment of bacterial prostatitis is limited by poor antibiotic penetration into prostatic tissue due to anatomical and physiological barriers, including the blood-prostate barrier, pH-dependent ion trapping, and protein binding.</p><p><strong>Methods: </strong>A systematic review was conducted to evaluate the intraprostatic pharmacokinetics of antibiotics. PubMed, Embase, and Medline were searched up to December 2024. In total, 44 studies reporting antibiotic concentrations in serum, prostate tissue, or prostatic fluids were included. Prostate tissue-to-serum ratios (PT/S) and pharmacokinetic parameters were analyzed to assess prostate penetration.</p><p><strong>Results: </strong>A total of 44 studies were included. Fluoroquinolones consistently demonstrated favorable intraprostatic penetration (PT/S ≥ 1), supporting their role as first-line agents. Trimethoprim-sulfamethoxazole (TMP-SMX) showed moderate penetration driven primarily by trimethoprim, while macrolides and tetracyclines exhibited variable but measurable distribution. Most β-lactams penetrated poorly into non-inflamed prostate tissue, although selected cephalosporins achieved moderate concentrations in acute inflammatory settings. Fosfomycin showed variable intraprostatic exposure, indicating that tissue diffusion does not uniformly translate into clinical efficacy, particularly in chronic disease.</p><p><strong>Conclusions: </strong>Antibiotic efficacy in prostatitis is strongly influenced by intraprostatic pharmacokinetics rather than drug class alone. Integrating physicochemical properties, disease subtype, and clinical guideline recommendations is essential for rational antibiotic selection and optimized treatment strategies.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1203-1248"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147645122","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}

{"title":"Lessons Learned: Defining the Right Specifications for Diagnostics in Outbreak Situations.","authors":"Markus Beutler, Pablo Bonvehí, May Chu, Veasna Duong, Rosanna W Peeling, Jonas Schmidt-Chanasit, Simon Jochum, Christoph Sticha-Kaiser, Noemi Castelletti, Matthias Strobl, Andreas Wieser","doi":"10.1007/s40121-026-01335-2","DOIUrl":"10.1007/s40121-026-01335-2","url":null,"abstract":"<p><strong>Introduction: </strong>The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic significantly changed the development and use of infectious disease diagnostics, emphasizing the need for rapid implementation, access equity, and revealing challenges in evaluation and licensing from unclear guidelines.</p><p><strong>Methods: </strong>An international expert panel was convened by Roche Diagnostics, Fraunhofer Institute for Translational Medicine and Pharmacology (Immunology, Infection and Pandemic Research division), and Ludwig Maximilians University to address these challenges. The panel aimed to develop parameters for designing minimal viable products and consequence-centered diagnostic strategies, focusing on the broader implications of test results for public health interventions and disease control rather than individual test performance.</p><p><strong>Results: </strong>Key findings included the need to tailor target product profiles to outbreak scenarios, considering socioeconomic factors and outbreak phases. Prioritizing rapid, cost-effective, and widely accessible tests, even at the expense of lower sensitivity was highlighted. Using such tools was effective during the SARS-CoV-2 pandemic because they were wider-reaching and identified more cases, especially in low-/middle-income countries where highly sensitive molecular tests had limited availability.</p><p><strong>Conclusion: </strong>Modeling different testing strategies allows outbreak control programs to quantify the impact of trade-offs between accessibility, affordability, and speed of diagnosis in different outbreak settings.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1385-1399"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129102/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147521079","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}

{"title":"Modeling the Public Health Impact of Introducing 4CMenB Vaccination for Infants in the Brazilian National Immunization Program.","authors":"Thatiana Pinto, Zeki Kocaata, Ana Medina, Igor Sampietri, Graziela Bernardino, Justyna Zawieja, Yaneth Gil-Rojas, Anna Tytuła, Maria Gabriela Graña, Elise Kuylen","doi":"10.1007/s40121-026-01322-7","DOIUrl":"10.1007/s40121-026-01322-7","url":null,"abstract":"<p><strong>Introduction: </strong>Invasive meningococcal disease (IMD) caused by meningococcal serogroup B (MenB) is a rare but serious illness with potentially life-threatening outcomes, particularly in infants. In Brazil, IMD is endemic, with the highest incidence in infants and most cases being due to MenB. The four-component MenB vaccine (4CMenB), with potential cross-protection against other meningococcal serogroups, is approved in Brazil for active immunization of individuals aged 2 months to 50 years. This modeling study assessed the public health impact on all age groups in Brazil of introducing routine vaccination with the 4CMenB vaccine in infants aged < 1 year.</p><p><strong>Methods: </strong>A static multigenerational multicohort model was developed using a discrete-time Markov approach over a 100-year time horizon. The model incorporates vaccine effectiveness, coverage, and waning rates to estimate the decrease in IMD incidence under the vaccination strategy (2 + 1 schedule at ages 3, 5, and 12 months) evaluated vs. no vaccination. Annual incidence rates of IMD by age group and serogroup between 2007 and 2023, excluding the COVID-19 pandemic period, were retrieved and adjusted for underreporting. Annual IMD-related deaths were calculated from age-specific case fatality rates.</p><p><strong>Results: </strong>Assuming 69% cross-protection against serogroup W (MenW), the 4CMenB vaccination of infants would avert 63,038 (- 21%) IMD cases caused by MenB and MenW, and 11,301 (- 20%) deaths in all age groups. The model predicted a reduction of 21,408 (- 43%) MenB cases and 3335 (- 43%) deaths due to MenB in the < 1-year age group.</p><p><strong>Conclusion: </strong>This modeling study highlights the considerable public health impact of introducing the 4CMenB vaccine for infants as part of Brazil's routine vaccination schedule. By reducing IMD morbidity and mortality, routine 4CMenB immunization has the potential to substantially decrease the disease burden, improve long-term health outcomes, and reinforce the potential impact of preventive measures within the national immunization program. Graphical Abstract available for this article.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1509-1524"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147633183","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}

{"title":"Prospective Study of Treatment with Ensitrelvir for COVID-19 in Patients Undergoing Hemodialysis (PROTECT-HD).","authors":"Mineaki Kitamura, Takahiro Takazono, Naoki Hosogaya, Shimpei Morimoto, Masahiro Kinoshita, Eriko Hamada, Ryosuke Shimizu, Shogo Miyazawa, Shintaro Tanaka, Tomoya Nishino, Hiroshi Mukae","doi":"10.1007/s40121-026-01327-2","DOIUrl":"10.1007/s40121-026-01327-2","url":null,"abstract":"<p><strong>Introduction: </strong>Patients on hemodialysis (HD) are vulnerable to COVID-19 and often excluded from pivotal antiviral trials. Ensitrelvir, an oral SARS-CoV-2 3C-like protease inhibitor approved in Japan, remains unevaluated in patients undergoing HD. This study assesses the pharmacokinetics, antiviral activity, safety, and clinical effectiveness of ensitrelvir in participants with mild COVID-19 undergoing HD.</p><p><strong>Methods: </strong>In this prospective, single-arm, open-label study (December 2024-April 2025), participants with mild COVID-19 undergoing HD received ensitrelvir 375 mg on Day 1, followed by 125 mg once daily on Days 2-5. On Visit 2 (Day 3), plasma ensitrelvir concentrations were measured at three time points prior to ensitrelvir administration-before, during, and after dialysis. On Visit 3 (Day 5), blood samples were collected after dialysis and prior to ensitrelvir administration. Clinical outcomes, body temperature, SARS-CoV-2 viral load, and viral titers were monitored through Day 8. The primary endpoint was plasma concentration of ensitrelvir relative to dialysis; secondary endpoints included clinical outcomes, body temperature, and changes in viral load.</p><p><strong>Results: </strong>Eight participants were evaluated: mean age, 68.1 years; mean body weight, 58.0 kg; and mean body mass index, 24.1 kg/m². Plasma ensitrelvir concentrations (geometric mean) remained stable, with similar levels before (18.0 µg/mL) and after dialysis (16.4 µg/mL). All participants were judged clinically effective by the investigator by Day 8. Body temperature normalized within 16.6-48.0 h in four participants, and in one participant after 59.2 h. SARS-CoV-2 viral load (mean ± standard deviation) declined by 2.85 ± 1.52 log₁₀ copies/mL from baseline to Day 8. No treatment-emergent adverse events, hospitalizations, or severe COVID-19-related complications occurred.</p><p><strong>Conclusion: </strong>No dose adjustment was required regardless of HD. In participants with mild COVID-19 undergoing HD, plasma ensitrelvir concentrations were similar to those previously reported in healthy individuals. Ensitrelvir showed favorable antiviral and clinical responses, supporting its safe use without dose adjustments.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials ID: jRCTs071240069.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1451-1466"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147592008","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}

{"title":"Antiretroviral Therapy Switching Among People with HIV in the United States is not Uncommon Despite Virologic Suppression: An OPERA Cohort Study.","authors":"Karam Mounzer, Michael D Osterman, Laurence Brunet, Ricky K Hsu, Anthony M Mills, Gerald Pierone, Michael G Sension, Jennifer S Fusco, Sean P Fleming, Girish Prajapati, Gregory P Fusco","doi":"10.1007/s40121-026-01334-3","DOIUrl":"10.1007/s40121-026-01334-3","url":null,"abstract":"<p><strong>Introduction: </strong>Although antiretroviral therapy (ART) has substantially improved treatment-related outcomes among people with HIV (PWH), individuals may still undergo ART regimen switches for clinical and non-clinical reasons. While prior studies have focused on virologic outcomes, contemporary data describing ART regimen switching in routine care in the US, especially among virologically suppressed PWH, are limited. In an evolving HIV treatment landscape, including expanding switch strategies, this study estimated the incidence of ART regimen switching among virologically suppressed PWH and characterized switch patterns.</p><p><strong>Methods: </strong>This observational cohort study used prospectively collected, routine electronic health records data from the OPERA Cohort. Adult PWH who were active in care and on a complete ART regimen between July 1, 2024 and June 30, 2025 were eligible. An ART regimen switch was defined as any change in antiretroviral agent, excluding pharmacokinetic boosting agents. Incidence of ART regimen switching was assessed during this 1-year period, overall and among PWH who were virologically suppressed. PWH who underwent a switch were characterized. Pre- and post-suppressed switch regimens, as well as patterns of suppressed switching, were outlined.</p><p><strong>Results: </strong>Among 73,078 PWH who were eligible, 8188 (11%) experienced ≥ 1 ART regimen switch during the 1-year study period. Of 68,147 individuals who were virologically suppressed to < 200 copies/ml during the study period, 6888 (10%) experienced ≥ 1 ART regimen switch while suppressed. The rate of suppressed switching was 14.5 per 100 person-years. Integrase inhibitors predominated both pre- and post-switch regimens. Overall, 51% of suppressed switches resulted in regimen simplification (lower pill count, fewer anchor agents, and/or transition to a complete long-acting injectable regimen).</p><p><strong>Conclusions: </strong>In this large, contemporary US cohort, ART regimen switching was somewhat common and most frequently occurred among virologically suppressed PWH. These real-world findings on the incidence and patterns of virologically suppressed switches provide insight into new trends in treatment optimization and the need for new therapeutic options.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1297-1314"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147498686","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}

{"title":"Respiratory Syncytial Virus Immunization Strategies for Older Adults in Gulf Cooperation Council Countries: Expert Consensus and Recommendations.","authors":"Nawal AlKaabi, Mohammed Abukhattab, Mona Al-Ahmad, Osama A A S Albaksami, Sara Al Dallal, Manaf M Alqahtani, Adel Salman Alsayyad, Ahmad Subhi, Hilal Al Hashami, Jamila Bin Adi, Fahad A A Alghimlas, Batoul Alwazan, Bassam Mahboub, Anas Adel, Onur Ozudogru, Salah Al Awaidy","doi":"10.1007/s40121-026-01313-8","DOIUrl":"10.1007/s40121-026-01313-8","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory syncytial virus (RSV) poses a significant health risk to older adults, particularly those with chronic comorbidities, in the Gulf Cooperation Council (GCC) countries. Despite its high burden, RSV remains underrecognized among older adults in this region. This manuscript aims to highlight the burden of RSV among older adults in GCC countries and provide expert consensus recommendations for the implementation of targeted prevention measures, including vaccination strategies.</p><p><strong>Methods: </strong>A multidisciplinary panel of experts from GCC countries reviewed international, regional, and country-level data on RSV. The panel formulated recommendations on the basis of a comprehensive literature review and expert consensus, focusing on the integration of RSV vaccination into routine immunization programs for older adults.</p><p><strong>Results: </strong>Older adults, especially those with chronic conditions including but not limited to cardiovascular disease, chronic kidney disease, chronic lung disease, and diabetes, are at an increased risk for severe RSV-related outcomes. Effective vaccines present an opportunity to significantly reduce the incidence and severity of RSV in this vulnerable population. Key recommendations for safeguarding older adults in GCC countries include implementing clear immunization schedules for adults at a country-level that include targeted RSV vaccination, especially among high-risk groups. Providing continuous education for healthcare professionals, increasing vaccine availability, equity, and affordability, conducting public awareness campaigns, and strengthening local surveillance systems also play a crucial role in addressing vaccine-preventable diseases such as RSV.</p><p><strong>Conclusions: </strong>Integrating RSV vaccination into routine immunization schedules, alongside other key vaccines, is essential for achieving comprehensive and optimal protection for older adults in GCC countries.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1425-1449"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147573895","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}

{"title":"Diagnostic Performance and Clinical Outcomes of Pertussis in Hospitalized Children in Relation to Available Vaccination Status: A Retrospective Cohort Study.","authors":"Dominika Lachowicz, Barbara Jastrzębska, Ewa Bukowska, Magdalena Grzeszczuk, Małgorzata Pieścik-Lech, Waleria Hryniewicz, Edyta Podsiadły","doi":"10.1007/s40121-026-01340-5","DOIUrl":"10.1007/s40121-026-01340-5","url":null,"abstract":"<p><strong>Introduction: </strong>Bordetella pertussis infections have resurged globally, posing notable public health challenges, particularly in pediatric populations. Poland remains the only EU country that continues to use the whole-cell pertussis vaccine (wP) in routine immunization. This study evaluated the vaccination status and diagnostic value of available testing modalities in relation to the clinical presentation and management of pertussis in pediatric patients.</p><p><strong>Methods: </strong>A retrospective cohort study of 269 children was conducted between January and December 2024. Patients with B. pertussis infection confirmed by real-time polymerase chain reaction (PCR; PCR-Fluorescence Probing Kit, Sansure, China) and/or serological testing (NovaLisa B. pertussis ELISA, Gold Standard Diagnostic, Germany) were included. Clinical characteristics and vaccination histories of confirmed cases were obtained from electronic medical records and telephone interviews with parents.</p><p><strong>Results: </strong>Pertussis was laboratory-confirmed in 76 of the 269 tested children (28%). PCR accounted for the majority of laboratory-confirmed cases and remained positive in some children during the fifth and sixth week of coughing. The highest proportion of cases was observed in infants under 1 year of age (n = 25, 32.9%). In older age groups, the proportion of cases reached 17% in children aged 1-5 years, 19% in those aged 6-11 years, and 10% in children aged 12-15 years. Adolescents over 15 years of age accounted for only two cases (2.6%). Twelve patients met criteria for severe pertussis (PSS > 5), which occurred in both vaccinated and unvaccinated children. The interval between disease onset and the last vaccine dose ranged from 1 month to 12 years, and a trend toward more pronounced clinical manifestations with longer time since the last booster was observed. No differences in clinical symptoms were found between children vaccinated with wP and acellular (aP) vaccines.</p><p><strong>Conclusions: </strong>The occurrence of cases several years after vaccination highlights the importance of continued surveillance to strengthen pertussis prevention strategies. Pertussis cases occurring within 5 years of wP vaccination warrant further population-based and molecular studies to evaluate potential factors such as waning immunity or antigenic changes in circulating B. pertussis strains.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1467-1477"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13128975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147609045","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}

{"title":"Multicenter Real-World Outpatient Use of Intravenous Omadacycline.","authors":"Lucinda J Van Anglen, Cathy L Koo, Kimberly A Couch","doi":"10.1007/s40121-026-01345-0","DOIUrl":"10.1007/s40121-026-01345-0","url":null,"abstract":"<p><strong>Introduction: </strong>Omadacycline is indicated for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. With limited real-world data, we report the clinical experience and outcomes of intravenous (IV) omadacycline in outpatient settings for treatment of any infection.</p><p><strong>Methods: </strong>We conducted a multicenter, retrospective review of adults who received IV omadacycline for any infection between April 2019 and November 2022. Clinical data included infection type, microbiology, therapy characteristics, and adverse events. Clinical success was defined as complete or partial symptom resolution at the completion of IV omadacycline. Recurrence data at 12 months were assessed for patients with bone and joint infections (BJI).</p><p><strong>Results: </strong>The study included 67 patients (median age, 59 years; 56.7% male; median Charlson index, 4) from 17 infectious disease office infusion centers. Most had BJI (53.7%), followed by complicated skin and skin structure infections (29.8%), complicated intra-abdominal infections (7.5%), respiratory tract infections (7.5%), and urinary tract infections (1.5%). The most common Gram-positive pathogen was methicillin-resistant Staphylococcus aureus (14.2%), and the most common Gram-negative pathogen was Enterobacter spp. (7.5%). Nontuberculous mycobacteria were identified in nine patients. Clinical success occurred in 86.9% of evaluable patients. Non-success was due to persistent infection (6.7%), adverse events (3.3%), and resistant pathogens (1.7%). Patients with BJI had sustained clinical success at 12 months in 72.4%.</p><p><strong>Conclusions: </strong>Omadacycline was shown to be safe and effective when used as IV therapy in the outpatient setting to treat a variety of serious infections, including bone and joint infections, and mycobacterial infections.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1525-1538"},"PeriodicalIF":5.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147633110","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}