First Patients in HONEST-PREPS

The study team is pleased to see that the regular care is resuming at the ICUs in Eastern Europe and that the number of COVID-19 patients has reduced significantly. The focus can now shift back to HAP/VAP incidences at the selected hospitals and the study team has been busy training the sites and resuming the start-up preparations. The team expects to have six sites activated and enrolling patients by mid July.

Study Aim

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 enrol 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.

About HONEST-PREPS

HONEST-PREPS is a prospective, observational, multicentre cohort study. The study population are the patients admitted to an ICU at risk for HAP/VAP.

Country level information:

• Serbia: 4x sites selected, 4x EC approvals received, 2x sites contracted, 2x sites initiated, 1x site activated and recruiting
• Czech Republic: 4x sites selected, 4x EC approvals received, 2x sites contracted, 2x sites activated, 1x site recruiting
• Croatia: 3x sites selected, 1x EC approvals received, 0x sites contracted, 0x sites activated
• Romania: 2x sites selected, 1x EC approvals, 0x sites contracted, 0x sites activated
• Hungary: 1x site selected, 0x EC approvals, 0x sites contracted, 0x sites activated
• Latvia: 2x sites selected, 0x EC approvals, 0x sites contracted, 0x sites activated

Planned study duration: HONEST-PREPS observational study is a preparation for a subsequent platform trial (HONEST-PLATFORM: HOspital  NEtwork STudy – PLAtform Trial FOR antibacterial Molecules). The set-up of the infrastructure, training of clinical staff and laboratory staff, data collection and preparation for the HONEST-PLATFORM is expected to take 18-24 months.