12/10/2023 combacte-net News Item

Eastern Europe’s Potential in High-Quality Clinical Research

For a long time, Eastern Europe has been a blind spot for clinical research in infectious diseases. The results of COMBACTE-NET’s HONEST-PREPS suggest that this might be a missed opportunity.

HOspital NEtwork STudy – Preparation for a Randomised Evaluation of anti-Pneumonia Strategies (HONEST-PREPS) aimed to build an infrastructure to prospectively enrol patients at risk of hospital-acquired or ventilator-associated pneumonia (HAP/VAP) in the intensive care unit (ICU).

It also aimed to determine the incidence, microbiological etiology (including antimicrobial resistance), management and outcome of HAP/VAP in the ICU.

Primarily Eastern European sites

Within two years, 2,165 patients were included at 12 hospital sites located primarily in Eastern Europe. This choice was deliberate, explains Project Manager Lina Gurskaite (University Medical Center Utrecht): “Eastern Europe is interesting for infectious disease research due to untapped talent, population characteristics and a prevalence of antimicrobial resistance. However, the infrastructure for conducting clinical research there is still developing. When setting up a clinical study, site selection preference often goes to more experienced hospital sites in Western and Southern Europe.”

Helping sites develop their capabilities

“With HONEST-PREPS, we set out to support promising sites in Serbia, the Czech Republic, Romania, Croatia and Albania to further develop their capabilities”, says Lina. “For example, we asked the sites to handle ethical submissions by themselves, which enhanced their knowledge of the process. We also encouraged them to select a dedicated study coordinator to assist the local principal investigator with day-to-day study tasks.” In addition, complimentary Good Clinical Practice training was offered to all local team members, while the LAB-Net team helped to identify gaps in sampling processes and microbiological procedures and provided training.

Overwhelmingly positive response

The benefits of this hands-on approach can be seen in the study’s outcomes, but also in the sites’ feedback. Lina: “The local research teams were very encouraged by the attention and support we provided. Many indicated their intention to use the results to improve their own hospital’s approach to diagnosing HAP/VAP. We hope that the success of the innovative approach used in the HONEST-PREPS study will encourage more studies to appreciate Eastern Europe’s potential for high-quality research.”

Overall, 13% of enrolled patients were diagnosed with HAP/VAP, with Staphylococcus aureus, Acinetobacter baumanni, Klebsiella pneumoniae, or Pseudomonas aeruginosa detected in over half the cases. “HONEST-PREPS delivered relevant information about the epidemiology of HAP/VAP from a region in Europe that is often underreported”, says coordinating researcher Henri van Werkhoven.

Continuing in ECRAID-Base

Although HONEST-PREPS has now reached completion, 8 of the 12 sites have transitioned to ECRAID-Base’s POS-VAP. This Perpetual Observational Study on Ventilator-Associated Pneumonia aims to activate 40 ICU sites in 15 European countries and enrol 20,000 patients in four years. It is part of the EU-funded ECRAID-Base project which is building on COMBACTE’s extensive infrastructure to establish a self-sustainable not-for-profit pan-European clinical research network: Ecraid.