ASPIRE-ICU: Focus on Final 10% and Data Completion

The ASPIRE-ICU study has reached over 90% of the total enrollment with 1840 inclusions to date, while still counting on every day!

Stable enrollment

The recruitment rate has been stable, with approximately 15 inclusions per week. The last few months registered a total of 69 enrolled subjects in May, 60 in June, and 60 in July. Despite the summer season with less expected pneumonia cases and a lack of staff on sites due to the holidays, recruitment remained constant.

Top enrollers of July 2018:

1. Tartu University Hospital, Estonia – 11 inclusions
2. Clinical Center Kragujevac, Serbia – 9 inclusions
3. UMC Utrecht, The Netherlands – 8 inclusions
4. Military Medical Academy, Bulgaria – 6 inclusions
5. Hospital Kyjov, Czech Republic – 5 inclusions
6. UH Wales, UK – 5 inclusions

These were followed by Clinical Center of Serbia (Serbia), HU Central de Asturias (Spain), Amphia Hospital (The Netherlands), CH Lyon Sud (France), CH Victor Dupouy (France), Jósa András County Hospital (Hungary), and UH Queen Joanna (Bulgaria) with one to four inclusions.

As the study nears completion, the study team expects to close sites in the upcoming months. The first site that has been closed successfully is Hospital Universitario Germans Trias i Pujol in Spain, after reaching the target of 100 inclusions. The ASPIRE-ICU study team would like to congratulate and thank the site for its collaboration, contribution and energy put in the study.

The ASPIRE-ICU study will be finished once the 2000 inclusions target is reached. At the current inclusion rate it is expected that the study will end in October or November 2018.

Data completion

Next to recruitment of new subjects, quality of the data is just as important. Data completion is followed by proper statistical analyses. Conclusions can then be drawn regarding the incidence of S. aureus and P. aeruginosa ICU pneumonia, specifically ventilator-associated pneumonia (VAP), and its association with patient-related and contextual factors.
Therefore in the upcoming months a stronger focus will be on data completion, database cleaning, and locking of completed subjects.

The final goal of the ASPIRE-ICU study is to develop a risk prediction model to quantify the risk of acquiring S. aureus or P. aeruginosa pneumonia during ICU stay. Associated with this, to improve the treatment of S. aureus or P. aeruginosa pneumonia and to decrease the mortality of patients in the ICU.

The ASPIRE-ICU study team is thankful and appreciative for all of the sites’ great effort so far, and looks forward to the last inclusions that will mark the end of the study.