Implementing integrated One Health surveillance of antimicrobial resistance (OH-AMR) remains a challenge globally, particularly in developing countries. Resource limitations, infrastructural gaps and inadequate technical capacity often hinder adherence to standardised antimicrobial resistance (AMR) surveillance guidelines, resulting in suboptimal data coverage and quality in resource-constrained settings. Moreover, considerable disparities exist in the design and execution of OH-AMR surveillance systems across regions, further complicating global data harmonisation and comparative analyses. Therefore, considering the complex ecosystem of OH-AMR and its effective implementation in the low- and middle-income countries (LMICs), a consensus-based multidisciplinary research agenda should be prioritised. In recent years, the Delphi method has become a popular tool in systematic and bias-free consensus building on a certain research domain or complex topics. Therefore, with the overarching objective of setting an operational standard for OH-AMR surveillance in LMICs, we aim to perform a Delphi study by engaging the experts from relevant domains.

To streamline the traditional time-consuming Delphi technique, we plan to implement a real-time Table-Top Delphi exercise for rapid consensus building. Moreover, to capitalise on the convention of experts from diverse fields in real-time, we propose to conduct the study during an international conference on AMR. With systematic modification in the Delphi technique, the study will be conducted in two rounds where the first round will be performed in real-time followed by a second round online. For this purpose, a set of questions being prepared based on the identified gaps in existing scientific literature, evidence and guidelines for OH-AMR will be used. The questionnaire will be dispatched on an electronic platform to accumulate the responses from the experts in real-time while ensuring the anonymity and controlled feedback. Consensus will be defined as 70% or more of respondents selecting the same option for a given question. Considering the engagement of stakeholders from multiple domains of the trifecta, a total of 50 participants will be recruited in the study to have 70% replicable consensus where responses from at least 40 participants are expected in both rounds. The outcome of this Delphi study will pave the way for the implementation of an optimised OH-AMR surveillance strategy, especially in the global south, leading to actionable outcomes.

The study will be conducted in accordance with the guidelines of the Ethics Advisory Board, Leipzig University, Germany. The Ethics Advisory Board has no concern on the study protocol (2025.08.27_eb_348) in terms of research ethics. Before participating in the survey, individuals will be required to provide informed consent through the Welphi electronic platform (Yes/No options). Participation will be entirely voluntary, and participants may withdraw their consent and discontinue participation at any stage of the study. The findings of the study will be shared with the major stakeholders including the quadripartite organisations, global and regional networks on AMR and presented in international conferences and social media forums on AMR. The outcome of the study will be published in a peer-reviewed journal.

Reports on the epidemiology and outcomes of acute kidney injury in the critically ill provide variable estimates based on differences in populations and underlying exposures. Current and generalisable incidence data are needed along with information on long-term patient and kidney outcomes.

The acute kidney injury-epidemiology in intensive care unit patients 2 (AKI-EPI 2) study aims to describe the occurrence and associated outcomes of AKI in critically ill patients worldwide. In addition, in selected centres, it aims to further describe the influence of AKI on long-term kidney and patient outcomes.

This is an international prospective, observational study of patients admitted to the intensive care unit (ICU). Each participating centre will record data from 100 consecutive patients fulfilling the following eligibility criteria: age≥18 years, admission to the ICU for more than 24 hours and informed consent according to the local ethics committee (EC). Exclusion criteria include end-stage kidney disease treated with maintenance renal replacement therapy (RRT), readmission to the ICU or missing AKI-defining data. Particular attention will be paid to recruiting centres from all continents and to ensure geographical diversity and representativeness. The target sample is 10 642 patients. The primary endpoint is the occurrence and maximum severity of AKI within 7 days of ICU admission according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints include AKI severity, AKI duration, RRT use and hospital survival. In selected centres, health-related quality of life, major adverse kidney events and vital status will also be captured at day 90 and 1 year from admission.

AKI-EPI 2 has been approved by the EC of the Ghent University and University Hospital. Approval will be sought by corresponding ECs for all participating centres.

Results will be presented at conferences, disseminated in peer-reviewed journals and will guide future research in the field of critical care nephrology.

NCT07207031.

Recent studies have shown that sodium-glucose cotransporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease in people at high cardiovascular risk, with or without type 2 diabetes. To date, all published studies have excluded kidney transplant recipients (KTRs). The Dapagliflozin Early After Kidney Transplantation (DEAK) study aims to prospectively evaluate the effects of the SGLT2 inhibitor dapagliflozin on kidney function, histopathology and metabolic outcomes among de novo KTRs.

This nationwide, investigator-initiated, single-transplant-centre, randomised, placebo-controlled, prospective clinical trial with two parallel groups aims to enrol 330 de novo adult KTRs (aged 18–75 years) with an estimated glomerular filtration rate (eGFR) of at least 25 mL/min/1.73 m². Participants are enrolled 6–8 weeks after transplantation and randomised 1:1 to receive dapagliflozin 10 mg/day or placebo for 3 years. Recipients with conditions that may intermittently affect kidney function, such as recent acute rejection or ongoing infection, are ineligible for inclusion.

The primary endpoint of the study is the difference in the chronic eGFR slope between treatment groups over 3 years, estimated using the European Kidney Function Consortium equation. Secondary and safety endpoints include changes in measured GFR (iohexol clearance), urinary albumin/creatinine ratio, blood pressure, infections and safety clinical chemistry. Exploratory endpoints evaluated after 1.5 years include changes in body composition and glucose tolerance; between-group differences in urinary metabolomics; transplant kidney biopsy inflammation and fibrosis scores (n=140) and kidney biopsy messenger RNA and protein expression (n=50). The protocol also includes a 10-year poststudy registry follow-up of eGFR slope, cardiovascular events and graft and patient survival.

The study protocol (EudraCT number: 2022-002428-10) has been approved by the Norwegian Medical Products Agency, the Regional Committee for Medical Research Ethics in Southeast Norway (REK Southeast number 426076) and by the data protection offices at the participating hospitals. The main results will be published in international, peer-reviewed scientific journals.

NCT05788276.

To estimate the relative effectiveness of vaccination (0, 1, 2, ≥3 doses) and prior infection, in combination, on risk of SARS-CoV-2 infection/reinfection.

Prospective cohort study.

We recruited participants for the Aegis Study from nine clinics across five US states. Participants must have been 18 years or older, had a history of a positive PCR for SARS-CoV-2, SARS-CoV-2 antigen or antibody test for SARS-CoV-2 with documentation or had no suspected or documented prior SARS-CoV-2 infection, intended to remain in study area for the next 12 months, and had elevated risk of future SARS-CoV-2 exposure. Exclusion criteria included acute illness, contraindication to phlebotomy, use of immunosuppressants or receipt of systemic immunoglobulins.

We used extended Cox regression with robust standard errors to estimate the association between time-varying number of vaccine doses and baseline prior infection on risk of infection/reinfection among a prospective cohort of US adults between February 2021 and January 2023, accounting for censoring using inverse probability of censoring weights. Additionally, to quantify possible exposure misclassification of prior infection by comparing prior infection operationalised as (1) documented/self-reported prior infection and (2) documented/self-reported prior infection plus nucleocapsid antibody indication of prior infection.

Of n=2178 who completed enrolment, n=1887 adults (63% female; 65% non-Latino White) contributed 366 905 days of observation. Participants contributed an average of 7.2 months of follow-up between February 2021 and January 2023. 28% (n=533) of individuals were infected or reinfected during the study period. Similar relative effectiveness was observed between the two different operationalisations of prior infection. After correction for prior infection status in the nearly 16% of those without study documentation of prior infection who had nucleocapsid antibody levels comparable to documented cases, relative to the unvaccinated with no prior infection, estimated effectiveness generally increased with increasing vaccine doses and prior infection (without prior infection: one (17%, 95% CI –31% to 47%), two (49%, 95% CI 31% to 63%), ≥three (71%, 95% CI 58% to 80%) vaccine doses; with prior infection: none (56%, 95% CI 30% to 72%), one (71%, 95% CI 42% to 86%), two (65%, 95% CI 49% to 76%), ≥three (80%, 95% CI 68% to 88%) vaccine doses). Pairwise comparisons at each vaccine dose (ref: no prior infection) revealed that prior infection provided additional protection, with stronger relationships for no and one dose (none: 56% (95% CI 30% to 72%), one: 66% (95% CI 28% to 84%), two: 31% (95% CI 7% to 49%), ≥three 31% (95% CI 0% to 53%)). There was a marked decrease in the protection offered by vaccination, prior infection, or both in the Omicron period versus pre-Omicron period.

In our real-world observational sample, vaccination (with two and ≥three vaccine doses of any Food and Drug Administration Emergency Use Authorization approved vaccine) and prior infection conferred benefits for protection against infection/reinfection. Re-classification of prior infection status based on antibody levels had little effect on results.

Stereotactic body radiotherapy (SBRT) delivered on an MRI-guided linear accelerator (MR-linac) enables highly conformal prostate cancer irradiation. The DESTINATION 2 trial is a federated, randomised phase II/R-IDEAL 2b study evaluating whether de-escalating the dose to prostate tissue, while maintaining a high dose to MRI-visible tumour(s) in two fractions, reduces genitourinary (GU) treatment-related adverse events (AE) without compromising disease control in men with localised prostate cancer.

200 men worldwide with localised, MRI-visible prostate cancer will be randomised 1:1 to receive either (1) prescribed uniform dose MR-linac SBRT (27 Gy in two fractions to the whole prostate and seminal vesicles with 0 mm CTV-PTV margin) or (2) de-escalated SBRT (20 Gy in two fractions to whole prostate with 0 mm CTV-PTV margin and 27 Gy in two fractions to MRI-visible tumour(s) with a 4 mm intraprostatic margin applied to the GTV. All treatments are delivered using MRI-guided adaptive Radiotherapy (MRIgRT). The primary endpoint is the absolute and relative risk reduction in acute grade 2+GU AE (CTCAE v5) within 12 weeks of completing radiotherapy. Secondary endpoints include late GU AE, acute and late gastrointestinal (GI) AE, sexual AE, patient-reported outcomes, dosimetry, technical feasibility and 2-year biochemical relapse-free survival.

This is a federated trial design in which each centre operates independently with its own sponsor, ethics committee approval and regulatory oversight. Each centre is responsible for obtaining and maintaining local ethics approval in accordance with their national and institutional requirements. The UK centre (The Royal Marsden NHS Foundation Trust) has received ethical approval from the East of England–Cambridge South Research Ethics Committee (REC reference: 24/EE/0163; IRAS: 338368). Results will be disseminated via peer-reviewed publications and conference presentations.

NCT06638541.