HONEST-PREPS Trial Story

Lina Gurskaite (University Medical Center Utrecht) Project Manager of HONEST-PREPS: “HONEST-PREPS has showed that hospital acquired infections is still a very prevalent problem causing additional burden to the patients. We have also learned that the infection prevention and identification measures differ significantly across the European countries.

The experience working on this study has also shown that conducting clinical studies and trials in the ICU setting is still very challenging. The contribution from ICU personnel and other clinical teams involved by taking part in the study on top of their normal duties is simply invaluable.

The most valuable part for me was the human factor of working with dedicated healthcare professionals across several European countries. We have learned that building more personal (face to face) relationships with the local study teams could have a long lasting effects in existing and future collaborations. Such relationships are important in strengthening the network and working together in fighting against infectious diseases”.

COVID-19 Hurdles

The kickoff of HONEST-PREPS has gone smoothly, no thanks to the start of the COVID-19 pandemic, with the study enrolling its first patients in May 2020.

The COVID-19 pandemic had an enormous effect on the study conduct, resulting in 1/3 of the selected sites not being activated and having activation and patient enrollment delayed. For the sites that did manage to start up, ensuring continuous enrolment was difficult due to additional care required for the increased number of patients in the ICUs during the pandemic.

This unquestionably resulted in additional workload for the ICU teams where in some cases the study had to be put on hold until the situation has improved. Most of the participating countries had patient visiting restrictions imposed, which did not allow the local research team to obtain the informed consent in order to enrol the patients in the study. By end of the enrolment period 2165 out of 3000 patients were recruited in HONEST-PREPS study.

Investing in Local Infrastructure

HONEST-PREPS has been building and developing a strong ongoing relationship with its sites by investing in the local infrastructure. The sites have been trained to perform high quality research. ‘On-the-job’ training was provided and the local research teams were offered complimentary Good Clinical Practice certification.

The sites received support from the operational team in Utrecht, the Netherlands during the trial. The study team worked hard on bringing less experienced sites up to the highest standards and build up their skills and knowledge in clinical trials.

It is anticipated that this type of approach could help strengthen the ongoing commitment to combat antibiotic resistance and difficult-to-treat infections.

Role of CLIN-Net

CLIN-Net has a vast hospital network and a well established infrastructure across Europe. Admittedly, Eastern European network is still relatively small compared to a widespread network in Western Europe. CLIN-Net contributed enormously in finding and evaluating suitable sites for HONEST-PREPS study in Eastern Europe. By carrying out site qualification visits, attending teleconferences, new hospitals were identified and additional connections were established which will undoubtedly make a contribution  to an existing network.

On the 1^st of May 2022, HONEST-PREPS concluded patient enrolment, after almost two years since the first patient was included. A total of 2165 patients have been included at 12 sites located in Serbia, Czech Republic, Romania, Croatia, Albania and France.

During the data cleaning process the local study teams’ participation was great, and responding to the queries and completing any missing data was done in a timely manner. Thanks to their cooperation the database lock for HONEST-PREPS study was achieved on August 14th 2022.

“The sponsor team learned that the key to a good relationship is visiting the sites and the local teams in person. This approach resulted in better collaboration, more effective communication, greater commitment by the local teams and higher recruitment rates” says Ms. Gurskaite.

HONEST-PREPS Continues in Ecraid

Even though the HONEST-PREPS study nears its end, well-performing HONEST-PREPS sites have had the opportunity to transition to ECRAID-Base’s POS-VAP (Perpetual Observational Study into Ventilator Associated Pneumonia) ICU study with the prospect of joining future Randomized Controlled Trials.

The aim of POS-VAP is to activate 40 ICU sites in 15 European countries and enroll 20.000 patients in 4 years. Well-performing and actively-recruiting HONEST-PREPS sites were recommended to transfer to the ECRAID-Base POS-VAP study after, if they met the qualification criteria.

UMC Utrecht team is excited to see that the relationships established with majority of the HONEST-PREPS sites will continue further by the same sites taking part in the POS-VAP and hopefully more studies and trials in the future.

Both the HONEST-PREPS and POS-VAP teams are very excited to be working together in making this transition as smooth as possible as well as the future prospects this new collaboration will bring within Ecraid.