Database Re-lock Achieved 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.

Small inconsistencies

The REJUVENATE study team noticed a small number of data inconsistencies during statistical analysis that required unlocking of the REJUVENATE database on May 14. Thanks to the concerted effort of Pfizer and CTCC data management and the site’s commitment to resolve the issues in question, database re-lock was achieved on May 29.

Statistical analysis expected Q2 2018

Statistical analysis can now be resumed and results of the full statistical analysis are now expected mid Q2 2018. In addition, the WP2A/REJUVENATE team is pleased to announce that all study sites are closed as of 16 May 2018.

About REJUVENATE

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.