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Objectives: Sexual assault (SA) is recognized as a public health problem of epidemic proportions. Guidelines recommend the administration of post‐exposure prophylaxis (PEP) after an SA. However, few data are available about the feasibility of this strategy, and this study was conducted to assess this. Methods: We conducted a retrospective, longitudinal, observational study in SA victims attending the Hospital Clinic in Barcelona from 2006 to 2015. A total of 1695 SA victims attended the emergency room (ER), of whom 883 met the PEP criteria. Five follow‐up visits were scheduled at days 1, 10, 28, 90 and 180 in the out‐patient clinic. The primary endpoint was PEP completion rate at day 28. Secondary endpoints were loss to follow‐up, treatment discontinuation, occurrence of adverse events (AEs) and rate of seroconversion. Results: The median age of participants was 25 years [interquartile range (IQR) 21–33 years] and 93% were female. The median interval between exposure and presentation at the ER was 13 h (IQR 6–24 h). The level of risk was appreciable in 47% (n = 466) of individuals. Of 883 patients receiving PEP, 631 lived in Catalonia. In this group, the PEP completion rate at day 28 was 29% (n = 183). The follow‐up rate was 63% (n = 400) and 38% (n = 241) at days 1 and 28, respectively. Treatment discontinuation was present in 58 (15%) of 400 patients who attended at least the day 1 visit, the main reason being AEs (n = 35; 60%). AEs were reported in 226 (56%) patients, and were mainly gastrointestinal (n = 196; 49%). Only 211 (33%) patients returned for HIV testing at day 90. A single seroconversion was observed in a men who have sex with men (MSM) patient at day 120. Conclusions: Follow‐up and compliance rates in SA victims were poor. In addition, > 50% of the patients experienced AEs, which were the main reason for PEP interruption. Strategies to increase follow‐up testing and new better tolerated drug regimens must be investigated to address these issues. [ABSTRACT FROM AUTHOR]

Issue: Recently, innovative clinical trial designs have been proposed, which have the potential to revolutionize clinical research. Whereas classical trials mostly evaluate only one investigational drug, platform trials embed various trials under a shared master protocol to enable the evaluation of multiple interventions for a disease or condition. Platform trials have mostly been used to evaluate cancer therapies, but also recently for COVID-19. The EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project aims to expand the use of platform trials as the backbone of drug development. Description of Issue: EU-PEARL is a Innovative Medicines Initiative 2 Joint Undertaking funded project (2019-2023), and a strategic public and private sector alliance, which aims to support the transformation of the classical trial approach into a cross-company collaborative, multi-compound platform, centred around patients, not diseases. How to operationalize and sustain this? A multi-stakeholder, mixed-methods approach is taken, focused around the concept of an integrated research platform (IRP), i.e., a common enabling framework for platform trials. The IRP will be established as a sustainable and scalable global solution, consisting of an infrastructure, workflows, and guidance on how to meet complex regulatory, ethical, legal, statistical and data requirements. Lessons from COVID-19 trials will be incorporated. Results: A disease-agnostic IRP is being developed, as well as four disease specific IRPs in four areas of high public health relevance, i.e. major depressive disorder, tuberculosis, nonalcoholic steatohepatitis, and neurofibromatosis. Lessons: Multi-stakeholder, multi-sector and multi-disciplinary collaborations are challenging in practice, but rewarding in outcomes. Given the complexity of setting-up these novel trials, clear communication and standardized terminology must be established, as well as continual awareness building of their components, challenges and benefits. Key messages: EU-PEARL intends to stage the clinical trials of the future, which will be more adaptive, efficient and patient-centred by design and outcome. EU-PEARĹs efforts aim to contribute to timely societal access to affordable medicines and address unmet health needs. [ABSTRACT FROM AUTHOR]

The Enterococcus species is the third main cause of infective endocarditis (IE) worldwide, and it is gaining relevance, especially among healthcare-associated cases. Patients with enterococcal IE are older and have more comorbidities than other types of IE. Classical treatment options are limited due to the emergence of high-level aminoglycosides resistance (HLAR), vancomycin resistance and multidrug resistance in some cases. Besides, few new antimicrobial alternatives have shown real efficacy, despite some of them being recommended by major guidelines (including linezolid and daptomycin). Ampicillin plus ceftriaxone 2 g iv./12 h is a good option for Enterococcus faecalis IE caused by HLAR strains, but randomized clinical trials are essential to demonstrate its efficacy for non-HLAR EFIE and to compare it with ampicillin plus short-course gentamicin. The main mechanisms of resistance and treatment options are also reviewed for other enterococcal species.