The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e.bedaquiline, delamanid) and repurposed (i.e.clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.

The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries. The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs. Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile. A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019.

Antimicrobial resistance represents a global health challenge, with Italy among the most affected countries in Europe. In response, the Veneto Region developed governance models to enhance antimicrobial stewardship (AMS) and infection prevention in both hospital and community settings. This study assessed the implementation of these models and explored strategies for improvement. A survey targeting hospital medical and district health management, hospital pharmacies, and primary care pharmaceutical departments was conducted to evaluate governance adherence, resource allocation, training, and reporting practices. Findings were analyzed by a focus group comprising regional experts, infectious disease specialists, microbiologists, and policymakers, which identified critical gaps and proposed actionable recommendations. Results revealed disparities in AMS implementation between hospital and community care, with key challenges including limited multidisciplinary collaboration, inconsistent resource distribution, and gaps in training. The focus group emphasized the need for stronger governance, standardized protocols, and improved communication to address these shortcomings. This study underscores significant gaps and opportunities within the Veneto Region’s healthcare system and provides a framework for enhancing AMS and infection prevention strategies, bridging the divide between hospital and community care to combat antimicrobial resistance effectively.

Prevalence and impact of occult HBV infection in HIV positive patients is controversial. The aims of this study were to determine the prevalence of occult HBV infection and its impact on histological and virological parameters. 52 HIV/HCV (but HBsAg-negative) co-infected patients, 29 HBsAg and anti-HCV negative chronic hepatitis, and 20 HBsAg positive chronic hepatitis controls were studied. DNA was extracted from frozen biopsies and amplified with primers for S, C and X regions, and for (ccc) HBV-DNA. Sera were tested for HBV-DNA with two quantitative assays (Cobas Amplicor HBV Monitor, and the real-time COBAS (r) Taqman HBV Test, Roche Diagnostics, UK). Occult HBV infection was detected in 7 (13.4%) liver biopsies of the study group, and in none case of the non viral chronic hepatitis group (p=0.04). All serum samples were HBV-DNA negative with Cobas Amplicor HBV monitor assay, while 3 cases were found positive with real time PCR. Statistical analysis didnt show any impact of occult HBV infection on liver histology, CD4+ cells count, HIV and HCV load, and ALT levels. Occult B infection is relatively frequent in HIV/HCV co-infected patients, and is underestimated by common HBV-DNA serological assays. However, it doesnt seem to exert a relevant impact.

Background/Objectives: Healthcare-associated infections (HAIs), including sepsis, represent a major challenge in clinical practice owing to their impact on patient outcomes and healthcare systems. Large language models (LLMs) offer a potential solution by analyzing clinical documentation and providing guideline-based recommendations for infection management. This study aimed to evaluate the performance of LLMs in extracting and assessing clinical data for appropriateness in infection prevention and management practices of patients admitted to an infectious disease ward. Methods: This retrospective proof-of-concept study analyzed the clinical documentation of seven patients diagnosed with sepsis and admitted to the Infectious Disease Unit of San Bortolo Hospital, ULSS 8, in the Veneto region (Italy). The following five domains were assessed: antibiotic therapy, isolation measures, urinary catheter management, infusion line management, and pressure ulcer care. The records, written in Italian, were anonymized and paired with international guidelines to evaluate the ability of LLMs (ChatGPT-4o) to extract relevant data and determine appropriateness. Results: The model demonstrated strengths in antibiotic therapy, urinary catheter management, the accurate identification of indications, de-escalation timing, and removal protocols. However, errors occurred in isolation measures, with incorrect recommendations for contact precautions, and in pressure ulcer management, where non-existent lesions were identified. Conclusions: The findings underscore the potential of LLMs not merely as computational tools but also as valuable allies in advancing evidence-based practice and supporting healthcare professionals in delivering high-quality care.