REJUVENATE Study Completes Patient Recruitment

On September 22^nd  COMBACTE-CARE’s REJUVENATE study announced  enrollment of the 3^rd and final  patient in  Cohort 3, and thus the completion of patient recruitment for this study!

In July the REJUVENATE Scientific Advisory Committee (SAC) unanimously recommended to proceed to Cohort 3 (final three patients) at the same maintenance dose of ATM 1500 mg/AVI 500 mg and continue to include patients with moderate renal impairment at the equivalent adjusted dose as per protocol.

The REJUVENATE team will now be focusing on the important end of study procedures to ensure a quality database for analysis and interpretation leading to the clinical study report.

REJUVENATE is a Phase II, pharmacokinetic and safety study of aztreonam-avibactam (ATM-AVI). This is a beta-lactam-beta lactamase inhibitor combination intended to treat serious Gram-negative bacterial infections in patients with limited or no treatment options.The trial will be carried out in collaboration with Pfizer.

The study’s primary objective is to determine the pharmacokinetics and safety of ATM-AVI in a population of hospitalized patients with a representative serious bacterial infection (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.