ASPIRE-ICU Completes Database Lock

Major milestone achieved in the ASPIRE-ICU study: on May 1^st, the database lock of all data has been performed!

In the last couple of months, all sites and the study team have been working hard to finalize this study. The focus was on data completion, sample retrieval, monitoring activities and (filing all) essential documentation.

The very first patient in ASPIRE-ICU was included on June 12, 2015. The study recruitment phase took almost 3,5 years and was completed on October 26, 2018. From that time onward, the last enrolled patients were followed up. The last patient last visit was performed in January 2019.

Many sites have already been closed or will be closed in the upcoming week. The final numbers for the ASPIRE-ICU study:

• 11 countries in Europe
• 30 hospitals
• 10.526 patients screened
• 2031 patients enrolled
• 8297 queries closed
• 31.372 samples taken
• almost 10.000 documents filed

The last study activities include filing the last essential documents, the sample analysis by the central lab and biomarker partners and preparing the final study report. As this study experienced many changes, e.g. in protocols and study staff, the study is also being evaluated with the sites and with the internal team. The most important lessons learned will be documented for future COMBACTE studies.

The ASPIRE-ICU study team is thankful to all investigators and the involved study team members for their continuous efforts and dedication in the last months!

Preliminary results

Preliminary results from the ASPIRE-ICU were presented during ECCMID 2019 in Amsterdam.

ASPIRE-ICU’s coordinator investigator Fleur Paling: These results are preliminary result on the main outcome of interest of ASPIRE-ICU, and are analyzed in cooperation with the statistical team from the University of Freiburg (Institute of Statistics). Upcoming after this are the multivariate analyses quantifying the independent association of S. aureus colonization status and other factors in relation to S. aureus ICU pneumonia. Finally, a prediction model will be built, that will predict the occurrence of S. aureus ICU pneumonia depending on available risk factors.”

Read the full insight from Fleur Paling.