This passing year was momentous for the ECRAID-Base consortium of 19 partner organisations based in nine European countries.
Funded through the European Union’s programme for research and innovation, the project helped establish Ecraid as an independent, not-for-profit organisation that today has its own head office, staff and operations. This new legal entity is tasked with coordinating the unification of several networks into one centralised sustainable network that shares resources, data and expertise to tackle urgent infectious diseases threats.
The first studies to benefit from this unified infrastructure are five Perpetual Observational Studies (POS), which lay the groundwork for rapidly implementing randomised controlled trials and other clinical trials in the face of future outbreaks. In August, the POS on ventilator-associated pneumonia (VAP) was the first to start recruiting patients, followed by the study on complicated urinary tract infection (cUTI) in October.
POS-VAP • First of the POS to start patient inclusion, POS-VAP has already enrolled 126 patients in 5 of the 40 selected sites. Sites in 7 more countries received approval to start enrolling, while site initiation visits are underway in Spain, Croatia and Albania.
POS-cUTI • The study on patients with cUTI wraps up the year with 41 selected sites in 15 countries, 30 enrolled patients across 7 active sites, 21 EC approvals, 20 ongoing regulatory submissions and 11 signed CTAs.
POS-ARI-ER • 41 sites have been selected for the POS on acute respiratory infections (ARI) in the emergency room. The team is now awaiting approval from the UK authority that oversees its work. The first countries to start recruiting patients will likely be UK, Spain, France and Italy.
POS-ARI-PC • The POS-ARI-PC focusses on patients with ARI presenting in primary care. In 2022, the team developed two overarching protocols called POS-ARI-PC Audit and POS-ARI-PC Core. The former allows for flexible, annual, anonymous, prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. This infrastructure will then be enhanced for patient sampling and follow-up under the POS-ARI-PC Core protocol. Implementation will begin in early 2023 in nearly 20 European countries.
POS-Disease X • This ambitious study aims to prospectively investigate and describe the aetiology, clinical management and clinical impact of atypical viral infections in immunocompromised patients in Europe. During the year, the team organised ten brainstorm meetings dedicated to defining the target population, inclusion criteria, study parameters, recruitment strategy, and sampling protocol. The master protocol that was drafted as a result has been finalised.
REMAP-CAP • Besides the POS, ECRAID-Base is also home to the European arm of this ground-breaking global adaptive platform trial REMAP-CAP. So far, it has reached over 7000 patients and 13.500 patient randomisations in over 200 European sites. In December, the trial received a £2.9 million grant for research into severe flu in the UK. Days later, the Irish Critical Care Clinical Trials Network was honoured at the Irish Healthcare Awards for its work on REMAP-CAP. To wrap up a successful year, Lennie Derde, Lead Investigator for Europe, hosted a group of Dutch investigators at a meeting in the city of Utrecht.
LAB-Net, Ecraid’s laboratory network, took the lead in designing a general microbiology questionnaire to collect data about clinical samples collected within the different POS. The team also created a general laboratory manual for the POS containing the latest and current requirements for good laboratory practice as well as good clinical sampling. This will be distributed to sites, both laboratory and clinical, along with all other study materials.
Special focus was placed on the development and implementation of data collection tools, including the master Data Management Plan that describes the project’s general data management policy, and a harmonised electronic Case Report From to be used by all POS studies.
The team tasked with pandemic preparedness and research into unexplained febrile illness with unusual epidemiology and/or clinical presentation responded swiftly on two emerging threats. It helped set up a rapid survey to assess the extent and geographical distribution of the suspected outbreak of acute hepatitis of unknown aetiology among children. Later, it joined efforts to tackle the outbreak of MPOX virus (formally monkeypox) by investigating vaccine the immunological response to MPOX infection and vaccination.
It was a busy year for the team responsible for organising trainings and educational activities for young researchers. Their initiatives include the workshops “How to make clinical trials more efficient” and “Young Investigator Workshop” at ECCMID, “Better methods for clinical studies in infectious diseases and clinical microbiology” in the Netherlands, and “Diagnostic stewardship in settings with limited resources and high AMR prevalence” in Croatia. In November, they co-organized the ERS Postgraduate course “How to improve research strategies in pneumonia”.
Good science requires good communications. In 2022, we rolled out the second iteration of the Ecraid website that includes a dedicated microsite for the ECRAID-Base project, as well as tagging functionality that makes it easy to find project- and study-related content. We also kicked off the "Purpose-driven, people-centred: The people behind the science" series of profile articles, with the first three shining a spotlight on project operatives working on different POS. Among the many other communications activities undertaken throughout the year are the first issues of the dedicated POS-VAP and POS-cUTI newsletters.
The project began in the midst of the COVID-19 pandemic, which severely restricted its ability to communicate in person. In 2022, consortium members finally got the chance to meet face-to-face. They first came together during its General Assembly in Antwerp, Belgium, in June. And in December, representatives of each team travelled to the Italian city of Verona to discuss challenges and find solutions together.
Last but not least, the consortium delivered its first periodic report to the European Commission in October.