Testing aztreonam-avibactam to treat complicated intra-abdominal infections
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 is carried out in collaboration with Pfizer.
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.
REJUVENATE is a prospective, open-label, single-arm, dose-confirming multicenter study. The study will be carried out in Spain, France and Germany. 40 adult patients with a diagnosis of complicated intra-abdominal infection and the need for a surgical intervention will be enrolled. First a cohort of ten patients will be assessed. When the safety and pharmacokinetic is confirmed, the study will proceed.
The proposed administration of ATM-AVI for enrolled patients is a loading dose, immediately followed by a maintenance infusion. From day two onwards, the dose will be raised. This treatment will be continued for five to fourteen days, deemed appropriate by the investigator. If the patients have shown significant clinical improvement, all study therapies may be discontinued. Assessment of clinical response will be made at End-of-Treatment (EOT), Test-of-Cure Visit (TOC) and Late-Follow-Up (LFU) points.