15/02/2023 combacte-net News Item

The year 2022 for CLIN-Net

During the COMBACTE years, CLIN-Net has built a solid network of 1,221 sites and 4,055 contacts. These sites participated in and contributed to large, international clinical trials focused on antimicrobial resistance. Per June 2022, CLIN-Net transitioned into Ecraid (the European Clinical Research Alliance on Infectious Diseases) to continue to use and strengthen this network infrastructure and to keep advancing clinical research in the field of infectious diseases.

Site selections

One of the main tasks of the CLIN-Net team is to perform site selections for a variety of clinical studies. In 2022, CLIN-Net conducted and/or supported 13 site selections.

One of the COMBACTE site selections performed by the team is for the Phase III trial SAATELLITE-2 in collaboration with Aridis Pharmaceuticals. SAATELLITE-2 evaluates the use of suvratoxumab in ICU (intensive-care unit) patients at high risk of developing nosocomial pneumonia caused by S. aureus. 77 sites have been pre-selected thus far with the help of CLIN-Net and LAB-Net, with the final aim to select 100 European sites.

Last year, the team also finalized a successful COMBACTE site identification in collaboration with GlaxoSmithKline. At completion, more than 10 European sites in 6 different countries with an expertise in SSTI diagnosis and management were identified as sites that could be contacted to participate in future GSK studies.

Within Ecraid, CLIN-Net has put forward its network for the ECRAID-Base Perpetual Observational Studies (POS) and aided with site selection for the European arm of REMAP-CAP. For REMAP-CAP, a total of 232 sites is currently active across 15 countries in Europe. Furthermore, CLIN-Net is involved in major European projects such as VACCELERATE.

Performance

CLIN-Net has built a rich portfolio of sites and their performance. By having insight in the previous quantitative and qualitative performance of sites in clinical trials, CLIN-Net can quickly select the most compatible sites when a study request reaches the team. All the data collected during site selections is carefully analyzed and used to differentiate between the sites. Matching the answers to the feasibility questionnaires to the key selection criteria ensures only the most appropriate sites are selected for participation.

Training

Besides the focus on building and consolidating the hospital network, CLIN-Net wants to ensure sites can deliver high quality research. Preferably all researchers within CLIN-Net are GCP certified. To get all CLIN-Net investigators trained, we offer GCP trainings. A total of 1097 researchers completed the (before given F2F and online) GCP training of which 27 participants passed the exam in the last year.

Within Ecraid, CLIN-Net supports ESCMID in the assessment on the training and educational needs of the network and has sent out a questionnaire to 750 PIs that participate in COMBACTE, PREPARE and REMAP-CAP studies. This survey showed a main interest in GCP training, research methodology and data management. In collaboration with ESCMID, CLIN-Net will further explore how these training interests can be met.

ECLs & Network

CLIN-Net will keep focusing on strengthening our relationships with the sites, investigators and the Ecraid Clinical Liaisons, key opinion leaders in the field of infectious diseases and/or members of established cooperative networks of experienced centers specializing in infectious diseases and ICUs. Now that the COVID-19 pandemic has come to an end, CLIN-Net is able to pick up country and site visits which provide an opportunity to meet local contacts and investigators in person, learn about the challenges and opportunities they encounter, and gain deeper understanding of the local healthcare infrastructure and politics. With the focus on collaboration, clinical research in the field of infectious diseases can be further improved.