{"title":"Analysis of Adverse Drug Reactions of Clofazimine Reported in the FDA Adverse Event Reporting System from 2004 to 2025 Q1.","authors":"Ruoyu Zhang, Yunwen Tao, Ziwei Bao, Jianping Zhang, Lingwu Zeng, Chen Fang, Meiying Wu","doi":"10.1007/s40121-025-01224-0","DOIUrl":"https://doi.org/10.1007/s40121-025-01224-0","url":null,"abstract":"<p><strong>Introduction: </strong>Clofazimine (CFZ) is an antimycobacterial agent used primarily for leprosy and multidrug-resistant tuberculosis. Despite its long clinical history, comprehensive pharmacovigilance data remain limited. This study aimed to analyze CFZ-associated adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS), identifying and pharmacovigilance signals.</p><p><strong>Methods: </strong>We conducted a retrospective pharmacovigilance analysis of the FAERS database from 2004 to 2025 Q1. ASCII-format data were imported into R 4.4.2 and deduplicated using FDA guidelines. Reports Listing CFZ as the primary suspect drug were identified using generic and brand names. AEs were coded using MedDRA 27.1. Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM), identified signals of disproportionate reporting. Subgroup analyses examined sex differences, while time-to-onset (TTO) analyses characterized latency patterns.</p><p><strong>Results: </strong>A total of 1287 CFZ-related AE reports were identified, with 995 (77.3%) classified as serious. Death (11.6%) and hospitalization (18.1%) were the most frequent serious outcomes. The majority of reports originated from the United States (59.4%). Demographic analysis showed higher reporting among females (49.6%) and patients aged 18-64 years (46.5%). Disproportionality analyses identified 135 preferred terms with positive safety signals. The most prominent signals included QT prolongation (ROR ~ 37.61), drug resistance (ROR ~ 17.31), skin hyperpigmentation (ROR ~ 13.07), and respiratory failure (ROR ~ 7.46), ranging from moderate to strong signal intensity. Subgroup analyses revealed significant sex differences in specific AE signals. TTO analysis indicated varied latency distributions across System Organ Class (SOC) and preferred term levels.</p><p><strong>Conclusion: </strong>Our pharmacovigilance assessment of FAERS data from 2004 to 2025 not only identified multiple serious and consistent safety signals associated with clofazimine such as prolonged QT intervals but also revealed a life-threatening AE respiratory failure. Although the analysis of these AEs cannot directly reflect causal relationships due to the nature of the FAERS data from spontaneous reporting, our findings highlight the critical importance of continuous pharmacovigilance, targeted clinical monitoring, and consideration of sex-based risk differences to ensure the safe use of clofazimine in clinical practice.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":5.3,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145052590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Szu-Yu Liu, Chien Chuang, Chih-Han Juan, Yu-Chien Ho, Sheng-Hua Chou, Yi-Ru Huang, Wan Chin, Hsiang-Ling Ho, Yi-Tsung Lin
{"title":"Comparison of Effectiveness between Ceftazidime/Avibactam and Other Active Therapies for Oxacillinase-48-Producing Carbapenem-Resistant Klebsiella pneumoniae Bacteremia in Taiwan.","authors":"Szu-Yu Liu, Chien Chuang, Chih-Han Juan, Yu-Chien Ho, Sheng-Hua Chou, Yi-Ru Huang, Wan Chin, Hsiang-Ling Ho, Yi-Tsung Lin","doi":"10.1007/s40121-025-01210-6","DOIUrl":"10.1007/s40121-025-01210-6","url":null,"abstract":"<p><strong>Introduction: </strong>Oxacillinase-48 (OXA-48)-producing carbapenem-resistant Klebsiella pneumoniae (CRKP) infections have been increasingly reported in Taiwan. Real-world studies regarding effective treatments for these infections are limited, and recommendations from international guidelines are controversial. The aim of this study was to compare clinical outcomes of OXA-48-producing CRKP bacteremia between patients treated with ceftazidime/avibactam (CZA) and those receiving other active therapies.</p><p><strong>Methods: </strong>Unique adult patients with OXA-48-producing CRKP bacteremia who received CZA or other therapies in vitro for at least 3 days between June 2017 and December 2024 at Taipei Veterans General Hospital were enrolled. Clinical characteristics and outcomes were compared among the treatment groups. OXA-48 strains were detected using polymerase chain reaction (PCR) followed by Sanger sequencing.</p><p><strong>Results: </strong>Of 45 patients included in this study, 18 were treated with CZA, and 27 were treated with other active therapies. Four patients received combination therapy. Most strains were OXA-48 producers (n = 42), and the rest were OXA-181 producers. No significant difference in 30-day mortality rate was observed between the treatment groups (22.2% versus 33.3%, p = 0.420), and even in critically ill patients (28.6% versus 43.8%, p = 0.389). Acute Physiology and Chronic Health Evaluation II (APACHE II) score (hazard ratio [HR] 1.07, 95% confidence interval [CI] 1.01-1.15, p = 0.028) was an independent risk factor for 30-day mortality, and colistin-based therapy (HR 3.02, 95% CI 1.00-9.13, p = 0.050) showed marginal significance with 30-day mortality. CZA use was not associated with 30-day mortality.</p><p><strong>Conclusions: </strong>Our findings revealed that CZA and other active therapies showed similar outcomes, but colistin-based regimens should be used cautiously.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2143-2156"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12426294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144804013","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":"JC Polyomavirus Infection: A Narrative Review.","authors":"Meital Elbaz, Dafna Yahav, Yair Mina, Alaa Atamna","doi":"10.1007/s40121-025-01199-y","DOIUrl":"10.1007/s40121-025-01199-y","url":null,"abstract":"<p><p>Progressive multifocal leukoencephalopathy (PML) is a devastating and often fatal central nervous system infection caused by John Cunningham polyomavirus virus (JCPyV). PML results from JCPyV reactivation in the setting of impaired cellular immunity in patients with HIV, organ transplantation, severe inflammatory disease, and an increasing number of modern treatments for cancer and autoimmune diseases. The presence of clinical and imaging manifestations consistent with the diagnosis coupled with the demonstration of JCPyV by PCR in cerebrospinal fluid (CSF) are considered diagnostic. Since there are no effective antiviral treatments available, restoring immune function is a key component in PML treatment. Novel immunotherapeutic approaches can ameliorate PML. Immunotherapeutic interventions, such as use of checkpoint inhibitors and viral specific T-cell, have shown promising results, but additional data are needed. In this review, we summarize the available data on risk factors for JCPyV neurological syndrome, clinical, laboratory, and radiological features, and propose an algorithm for management.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2007-2028"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144730185","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}
Ricard Ferrer, Sonia Luque, Luis Martínez-Martínez, Alfonso de Lossada, Marta Maroto-Diaz, Carlota Moya-Alarcón, Maria Carmen de Ceano-Vivas, Yolanda Moreno, James Dennis, Silviya Nikolova, Evangelos Zormpas, Edward Broughton, Maria Gheorghe
{"title":"Estimating the Value of Aztreonam-Avibactam in Treating Metallo-beta-Lactamase-Producing Enterobacterales Infections in Spain Using the STEDI AMR Value Framework.","authors":"Ricard Ferrer, Sonia Luque, Luis Martínez-Martínez, Alfonso de Lossada, Marta Maroto-Diaz, Carlota Moya-Alarcón, Maria Carmen de Ceano-Vivas, Yolanda Moreno, James Dennis, Silviya Nikolova, Evangelos Zormpas, Edward Broughton, Maria Gheorghe","doi":"10.1007/s40121-025-01202-6","DOIUrl":"10.1007/s40121-025-01202-6","url":null,"abstract":"<p><strong>Introduction: </strong>Treatments for serious infections caused by multidrug-resistant gram-negative bacteria, including metallo-β-lactamase-producing Enterobacterales (MBL-EB), are limited and aztreonam with avibactam (ATM-AVI) is the first β-lactam/β-lactamase inhibitor combination active against MBL-EB approved in Europe and approved for reimbursement by the Spanish National Health System (NHS). This study aims to estimate the value of adding ATM-AVI as a new first-line treatment into the current strategy (ATM-AVI → cefiderocol → colistin + meropenem) in patients with hospital-acquired/ventilator-associated pneumonia (HAP/VAP) and complicated intra-abdominal infections (cIAI), caused by MBL-EB from the Spanish NHS perspective.</p><p><strong>Methods: </strong>A dynamic disease transmission model was developed to assess the value of ATM-AVI considering the transmission, diversity and enablement components of the value framework for antibiotics, called STEDI (spectrum, transmission, enablement, diversity, insurance). Transmission and diversity value were described by estimating direct population-level impact on treatment outcomes and resistance development. Enablement value was estimated by linking population-level improvements in antimicrobial effectiveness into improved prophylactic effectiveness. Inputs for efficacy, resistance, adverse events, and costs were sourced from the REVISIT study, literature and expert opinion. A 10-year infection transmission horizon was used; quality-adjusted life years (QALYs) were estimated over a lifetime and valued using a willingness-to-pay (WTP) threshold of €25,000/QALY gained to calculate the net monetary benefit (NMB). Costs and benefits were discounted at a rate of 3%.</p><p><strong>Results: </strong>Over 10 years, the intervention strategy introducing ATM-AVI was dominant, leading to a 2.96% proportional reduction in resistance, 19,533 fewer infections and 4662 lives saved (47,319 QALYs gained) and a cost saving of €40.5 million. The NMB was €1.22 billion.</p><p><strong>Conclusions: </strong>In Spain, ATM-AVI is a highly cost-effective and urgently needed treatment option for patients with MBL-EB including HAP/VAP and cIAI infections. Using the novel STEDI framework unlocks the considerable value of a new antibiotic which is essential to support incentives for the development of new antimicrobials.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2071-2092"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144730183","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}
Alessio Comitangelo, Alfredo Vozza, Giovanna Ditaranto, Giuseppe Re, Ada Berloco, Erasmo Porfido, Carlo Custodero, Domenico Comitangelo, Sara Madaghiele, Andrea Portacci, Cosimo Tortorella, Giuseppina Piazzolla
{"title":"Early Prediction of In-Hospital Mortality in Patients with Acute Infections: Development of the Acute Severity Infection Score (ASIs).","authors":"Alessio Comitangelo, Alfredo Vozza, Giovanna Ditaranto, Giuseppe Re, Ada Berloco, Erasmo Porfido, Carlo Custodero, Domenico Comitangelo, Sara Madaghiele, Andrea Portacci, Cosimo Tortorella, Giuseppina Piazzolla","doi":"10.1007/s40121-025-01200-8","DOIUrl":"10.1007/s40121-025-01200-8","url":null,"abstract":"<p><strong>Introduction: </strong>Early prognostic stratification in patients hospitalized for acute infections is a major clinical challenge. Existing tools, such as the Sequential Organ Failure Assessment (SOFA) score and Charlson Comorbidity Index (CCI), were not specifically developed for this purpose.</p><p><strong>Objectives: </strong>We aimed to design a novel multidimensional prognostic score, the Acute Severity Infection score (ASIs), to predict in-hospital mortality using routinely available clinical data.</p><p><strong>Methods: </strong>This retrospective cohort study included 149 adults admitted with acute infections to an internal medicine unit between January 2023 and December 2024. In-hospital all-cause mortality was the primary outcome. Demographic, clinical and laboratory variables obtained within 12 h of admission were analyzed. Variables significantly associated with mortality in both univariate and multivariate regression were incorporated into the ASIs, which ranges from 0 to 7 points. Its performance was compared to SOFA and CCI using ROC curve and Cox regression models.</p><p><strong>Results: </strong>In-hospital mortality occurred in 25.5% of patients. Five variables were independently associated with mortality: lactate ≥ 2.2 mmol/l, frailty composite (confined to bed status, long-term oxygen therapy or advanced malignancy), hemodynamic instability or need for non-invasive ventilation, age ≥ 79.5 years and symptom onset ≥ 3.5 days before admission. ASIs showed the highest discriminative ability (AUC = 0.883) compared to SOFA (AUC = 0.612) and CCI (AUC = 0.742). In multivariate models including all three scores, only ASIs retained independent prognostic significance.</p><p><strong>Conclusions: </strong>The ASIs is a simple tool for early prognostic stratification of patients hospitalized with acute infections. It outperforms existing scores and may enhance clinical decision-making in real-world medical settings.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2053-2070"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12426296/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144730182","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}
Matteo Bassetti, Antonella Cardone, Fatima Cardoso, Vanessa Carter, Oliver A Cornely, Marco Falcone, Daniel Gallego, Maddalena Giannella, Paolo Antonio Grossi, Livio Pagano, Nicola Silvestris, Nikolaos V Sipsas, Alex Soriano, Mario Tumbarello, Pierluigi Viale
{"title":"Can We Lower the Burden of Antimicrobial Resistance (AMR) in Heavily Immunocompromised Patients? A Narrative Review and Call to Action.","authors":"Matteo Bassetti, Antonella Cardone, Fatima Cardoso, Vanessa Carter, Oliver A Cornely, Marco Falcone, Daniel Gallego, Maddalena Giannella, Paolo Antonio Grossi, Livio Pagano, Nicola Silvestris, Nikolaos V Sipsas, Alex Soriano, Mario Tumbarello, Pierluigi Viale","doi":"10.1007/s40121-025-01204-4","DOIUrl":"10.1007/s40121-025-01204-4","url":null,"abstract":"<p><p>Effective antibiotics are a cornerstone of treatment for heavily immunocompromised patients such as those undergoing cancer treatment or transplantation procedures, as these patients are at particularly high risk of adverse outcomes from infections. However, rising antimicrobial resistance (AMR) threatens to undermine our ability to deliver modern treatments, and without action, recent advances in clinical care may be undone. In this narrative review, we examine the broad burdens of AMR for patients and healthcare systems, including excess mortality, underlying disease outcomes, economic costs and the damage to patients' quality of life. Despite the profound impact on individual wellbeing, the patient voice and patient-reported experience measures are largely absent from current research. To protect the everyday benefits of antibiotics, it is vital to educate all those involved in patient care on how we can combat AMR, including appropriate testing, use of effective antibiotics and infection control procedures. Moreover, given the high investment in novel anticancer treatments, good antimicrobial stewardship has the potential to deliver overall cost savings to healthcare systems while ensuring that patients can safely access and benefit from these therapies.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2029-2052"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425879/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144794340","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}
Lorena De La Mora, Montserrat Laguno, Berta Torres, Ivan Chivite, Alberto Foncillas, Alexy Inciarte, Júlia Calvo, Ana González-Cordón, Juan Ambrosioni, Leire Berrocal, Elisa De Lazzari, Esteban Martínez, José Luís Blanco, Rubén Mora, Estela Solbes, Ana Rodriguez, Pilar Callau, Laia Miquel, Jordi Blanch, Duncan Short, Josep Mallolas, Maria Martínez-Rebollar
{"title":"Long-Term Health Outcomes of People with HIV Engaged in Chemsex: A Prospective Cohort Study on Drug Use, Sexual Behaviour, Sexually-Transmitted Infections and Vulnerability.","authors":"Lorena De La Mora, Montserrat Laguno, Berta Torres, Ivan Chivite, Alberto Foncillas, Alexy Inciarte, Júlia Calvo, Ana González-Cordón, Juan Ambrosioni, Leire Berrocal, Elisa De Lazzari, Esteban Martínez, José Luís Blanco, Rubén Mora, Estela Solbes, Ana Rodriguez, Pilar Callau, Laia Miquel, Jordi Blanch, Duncan Short, Josep Mallolas, Maria Martínez-Rebollar","doi":"10.1007/s40121-025-01201-7","DOIUrl":"10.1007/s40121-025-01201-7","url":null,"abstract":"<p><strong>Introduction: </strong>Chemsex, the intentional use of drugs to enhance sexual experiences among gay, bisexual, and other men who have sex with men (gbMSM), is linked to high-risk sexual behaviours and increased sexually transmitted infections (STIs). Data on its long-term evolution after implementing specific strategies in HIV settings are limited. We evaluated the incidence of drug use, sexual behaviour, STIs, and vulnerabilities over 3 years following a specific approach at the HIV Unit of Hospital Clinic in Barcelona, Spain.</p><p><strong>Methods: </strong>We included 209 gbMSM living with HIV who engaged in chemsex in a prospective cohort (2018-2022). Quarterly visits assessed sexual behaviours, drug use, and STIs screening. Data were collected via self-administered questionnaires, medical records, and microbiological tests. Statistical analyses included descriptive statistics and Poisson regression models.</p><p><strong>Results: </strong>Chemsex incidence decreased significantly (IRR 0.88, 95% CI 0.83-0.92, p < 0.001). People engaging in intravenous drug use (slamming) decreased in year 2 (IRR 0.71, 95% CI 0.52-0.98, p = 0.037) but rose non-significantly in year 3 (IRR 0.86, 95% CI 0.60-1.25, p = 0.434). High-risk sexual behaviours persisted, specifically unprotected anal sex (IRR 1.02, 95% CI 0.96-1.08, p = 0.481) and unprotected fisting (IRR 1.20, 95% CI 1.05-1.39, p = 0.010). Syphilis cases declined (IRR 0.40, 95% CI 0.26-0.60, p < 0.001). At baseline, 29% had HCV antibodies, with five new acute HCV cases. Concerns about chemsex decreased (IRR 0.52, 95% CI 0.43-0.63, p < 0.001), whereas the demand for sexuality-related assistance increased (IRR 1.53, 95% CI 1.20-1.94, p = 0.004). Loss to follow-up (21%) was greater among younger individuals, people engaging in intravenous drug use (slamming) (IRR 2.43 95% CI 1.33-4.42, p = 0.004), detectable HIV viral load (IRR 3.01, 95% CI 1.57-5.76, p = 0.001), and greater need for help (IRR 1.35, 95% CI 1.03-1.78, p = 0.03). Migrants and sex workers had higher rates of syphilis, lower education levels, and increased prevalence of STIs.</p><p><strong>Conclusion: </strong>Chemsex incidence and syphilis rates declined, but persistent high-risk behaviours, subgroup vulnerabilities, and increasing demand for sexuality-related assistance require targeted interventions and comprehensive support.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2113-2130"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144784260","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}
Alexander Domnich, Francesco Lapi, Andrea Orsi, Piero Luigi Lai, Alessio Signori, Luca Pestarino, Pier Claudio Brasesco, Marta Vicentini, Anna Puggina, Alen Marijam, Maria João Fonseca, Elisa Turriani, Carlo-Simone Trombetta, Giada Garzillo, Federica Stefanelli, Valentina Ricucci, Bianca Bruzzone, Donatella Panatto, Giancarlo Icardi
{"title":"A Cluster Randomized Study to Explore Case Definitions, Clinical Course and Consequences of RSV in Community-Dwelling Adults Aged ≥ 50 Years.","authors":"Alexander Domnich, Francesco Lapi, Andrea Orsi, Piero Luigi Lai, Alessio Signori, Luca Pestarino, Pier Claudio Brasesco, Marta Vicentini, Anna Puggina, Alen Marijam, Maria João Fonseca, Elisa Turriani, Carlo-Simone Trombetta, Giada Garzillo, Federica Stefanelli, Valentina Ricucci, Bianca Bruzzone, Donatella Panatto, Giancarlo Icardi","doi":"10.1007/s40121-025-01205-3","DOIUrl":"10.1007/s40121-025-01205-3","url":null,"abstract":"<p><strong>Introduction: </strong>In Europe, surveillance of respiratory syncytial virus (RSV) has been recently incorporated into existing influenza monitoring platforms that are based on influenza-like illness (ILI) or acute respiratory infection (ARI) case definitions. This study aims to compare RSV rates captured by ARI versus ILI case definitions and to describe the clinical and economic trajectories of RSV in older adults.</p><p><strong>Methods: </strong>The study was conducted in Italy during the 2023/2024 and 2024/2025 seasons. Thirty-eight general practitioners were randomized 1:1 to enroll individuals ≥ 50 years presenting for care and meeting the European criteria for ARI or ILI, respectively. Alternative definitions were also explored. All subjects were tested for respiratory pathogens. RSV-positive individuals were followed for up to one month.</p><p><strong>Results: </strong>Of 1431 patients (ARI: 741; ILI: 690) included, 5.2% tested positive for RSV. Odds of RSV in the ARI group (5.8%) was 26% higher than in the ILI group (4.6%) [odds ratio (OR) 1.26; 95% CI 0.60-2.65]. Exclusion of GPs with unexpectedly low enrollment rates increased the OR to 1.67 (95% CI 0.80-3.42). Conversely, adults in the ILI group showed higher rates of influenza A (OR 0.83; 95% CI 0.47-1.44) and SARS-CoV-2 (OR 0.57; 95% CI 0.34-0.95). A proposed alternative case definition, denoted as ARI with wheezing and/or productive cough and/or rhonchi and/or dyspnea was sensitive at 92.0% and specific at 30.8%. Among 75 RSV-positive outpatients, the case-complication, case-hospitalization and case-fatality rates were 30.7%, 2.7%, and 1.3%, respectively. The mean costs per RSV case were € 168.71 from the payer perspective and up to € 899.51 from the societal perspective.</p><p><strong>Conclusions: </strong>Compared to a highly sensitive ARI definition, ILI-based surveillance likely underestimates the incidence of RSV. Further qualifiers can enhance specificity of the ARI case definition. The study confirms a significant burden of RSV in older adults.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2093-2111"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12426295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768619","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":"A Cohort Study of Pediatric Severe Community-Acquired Pneumonia Involving AI-Based CT Image Parameters and Electronic Health Record Data.","authors":"Mengyuan He, Jianpeng Yuan, Aijiao Liu, Rui Pu, Wenqi Yu, Yinzhu Wang, Li Wang, Xing Nie, Jinsheng Yi, Hongman Xue, Junfeng Xie","doi":"10.1007/s40121-025-01197-0","DOIUrl":"10.1007/s40121-025-01197-0","url":null,"abstract":"<p><strong>Introduction: </strong>Community-acquired pneumonia (CAP) is a significant concern for children worldwide and is associated with a high morbidity and mortality. To improve patient outcomes, early intervention and accurate diagnosis are essential. Artificial intelligence (AI) can mine and label imaging data and thus may contribute to precision research and personalized clinical management.</p><p><strong>Methods: </strong>The baseline characteristics of 230 children with severe CAP hospitalized from January 2023 to October 2024 were retrospectively analyzed. The patients were divided into two groups according to the presence of respiratory failure. The predictive ability of AI-derived chest CT (computed tomography) indices alone for respiratory failure was assessed via logistic regression analysis. ROC (receiver operating characteristic) curves were plotted for these regression models.</p><p><strong>Results: </strong>After adjusting for age, white blood cell count, neutrophils, lymphocytes, creatinine, wheezing, and fever > 5 days, a greater number of involved lung lobes [odds ratio 1.347, 95% confidence interval (95% CI) 1.036-1.750, P = 0.026] and bilateral lung involvement (odds ratio 2.734, 95% CI 1.084-6.893, P = 0.033) were significantly associated with respiratory failure. The discriminatory power (as measured by the area under curve) of Model 2 and Model 3, which included electronic health record data and the accuracy of CT imaging features, was better than that of Model 0 and Model 1, which contained only the chest CT parameters. The sensitivity and specificity of Model 2 at the optimal critical value (0.441) were 84.3% and 59.8%, respectively. The sensitivity and specificity of Model 3 at the optimal critical value (0.446) were 68.6% and 76.0%, respectively.</p><p><strong>Conclusion: </strong>The use of AI-derived chest CT indices may achieve high diagnostic accuracy and guide precise interventions for patients with severe CAP. However, clinical, laboratory, and AI-derived chest CT indices should be included to accurately predict and treat severe CAP.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2131-2141"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798979","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}
Olga C Aroniadis, Beth Guthmueller, Kaitlin Dehlin, Shivam Srivastava, Paul Feuerstadt, Anthony Lembo, Horst C Weber
{"title":"Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome.","authors":"Olga C Aroniadis, Beth Guthmueller, Kaitlin Dehlin, Shivam Srivastava, Paul Feuerstadt, Anthony Lembo, Horst C Weber","doi":"10.1007/s40121-025-01208-0","DOIUrl":"10.1007/s40121-025-01208-0","url":null,"abstract":"<p><strong>Introduction: </strong>The safety and efficacy of microbiota-based products in patients with irritable bowel syndrome (IBS) and recurrent Clostridioides difficile infection (rCDI) has not been studied. Fecal microbiota, live-jslm (RBL; REBYOTA<sup>®</sup>) is an FDA-approved, single-dose, microbiota-based product to prevent rCDI in adults following standard-of-care (SOC) antibiotic treatment. This was an exploratory subgroup analysis of PUNCH CD3-OLS, a phase 3, open-label, prospective study conducted in the United States (US) and Canada, to evaluate the safety and efficacy of RBL in participants with documented rCDI and concurrent IBS.</p><p><strong>Methods: </strong>Participants aged ≥ 18 years with a diagnosis of rCDI and who completed SOC antibiotic treatment were enrolled in this study. The primary endpoint of PUNCH CD3-OLS was the number of participants with RBL- or administration-related treatment-emergent adverse events (TEAEs). Secondary endpoints included treatment success at 8 weeks and sustained clinical response at 6 months. In this subgroup analysis, ongoing IBS was confirmed based on medical record documentation at the time of RBL administration.</p><p><strong>Results: </strong>Among the 697 RBL recipients, 90 had comorbid IBS. After RBL administration, 52 participants with IBS (57.8%) and 278 participants without IBS (45.8%) experienced TEAEs through 8 weeks. Most TEAEs were mild (22.2% with IBS, 20.1% without IBS) or moderate (26.7% with IBS, 18.8% without IBS). Serious TEAEs were reported by 1 participant with IBS (pneumonia reported to be unrelated to RBL) and 26 participants without IBS [most of which were related to preexisting conditions (3.1%)]. Among all participants, 68.9% with IBS and 75.6% without IBS had absence of CDI diarrhea through 8 weeks after RBL administration. Of the participants with treatment success, 82.3% with IBS and 92.2% without IBS had sustained clinical response through 6 months.</p><p><strong>Conclusion: </strong>RBL is a safe and efficacious option to prevent CDI recurrence in patients with concurrent IBS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03931941.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"2157-2169"},"PeriodicalIF":5.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12425869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816456","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}