Celebrating Success: Major Achievement in COMBACTE-CARE

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HONEST-PREPS Receives First Ethical Approvals in Record Time

COMBACTE-NET’s observational study into Hospital Acquired and Ventilator Associated Pneumonia (HAP/VAP) is full steam ahead in setting up in Eastern Europe. The study received its first approval from local Ethical Committee (EC) for two of its selected sites in Serbia. This has been done in just two weeks time, after submitting the documents at the very end of December 2019. The team looks forward to further receive timely EC approvals from other selected sites in Czech Republic and Croatia.

The aim of the HONEST-PREPS (HOspital NEtwork STudy – Preparation for a Randomized Evaluation of anti-Pneumonia Strategies) is to set up an infrastructure to prospectively enroll patients at risks of HAP/VAP in the Intensive Care Unit (ICU). Collected data will be used to inform future diagnostic, preventative and therapeutic trials. In addition to capturing HAP/VAP episodes in a timely manner, HONEST-PREPS will determine the incidence, microbiological etiology (including antibiotic resistance), management and outcome of HAP/VAP in the ICU.

HONEST-PREPS aims to build and develop a strong ongoing relationship with its sites by investing in the local infrastructure. The sites will be trained to perform high quality research. ‘On-the-job’ training will be provided and the local research teams will be offered complimentary Good Clinical Practice certification. The sites will receive support from the operational team in Utrecht, the Netherlands during the trial. The study team will bring less experienced sites up to the highest standards and build up their skills and knowledge in clinical trials. The COMBACTE team believes that this type of approach will help strengthen the ongoing commitment to combat antibiotic resistance and difficult-to-treat infections.

The sponsor’s team is encouraged by the sites’ displayed commitment. This new approach to clinical trials could set the gold standards for the future trials, working towards the common goal of fighting bacterial resistance.

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