Data Base Lock Completed in REJUVENATE Study

On March 1st, COMBACTE-CARE’s REJUVENATE study achieved database lock, following completion of the blind data review (i.e. review of template tables, files and listings before database lock and release of data for analysis) at the end of February. This crucial milestone marks the start of the final statistical analysis and writing of the final clinical study report.

Following the database lock, close-out visits for French, German and Spanish sites will take place. Results of the full statistical analysis are expected at the beginning of Q2 2018, with finalization of the complete study report in Q3 2018.

The REJUVENATE team is grateful for the hard work and dedication of the study sites and staff, whose constant support and collaboration greatly contributed in achieving this milestone.

REJUVENATE’s primary objective is to test ATM-AVI as a treatment for hospitalized patients with a complicated intra-abdominal infection. Secondary objectives include assessment of treatment outcome (proportion of patients with clinical cure at the TOC visit) and the relationship between exposure of ATM-AVI and clinical cure.