Recruitment activities in the 2nd REJUVENATE cohort at the optimized avibactam dose resumed in January 2017 in Germany and Spain, followed by France after regulatory approval of the recent protocol amendment in February.
Owing to the study sites’ continuing commitment, 7 new patients in France and Spain could be recruited within only 8 days. At the moment, 20 study patients have been or are being treated with ATM/AVI. The current recruitment boost also takes us another step forward to our next milestone, the 2nd safety review of 10 cohort 2 patients that complete all safety and PK assessments, as well as to reaching our recruitment goal of 40 patients.
REJUVENATE is a prospective, open-label, single-arm, dose-confirming multicenter study. The study will be carried out in Spain, France and Germany. Forty 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.