REJUVENATE
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 was carried out in collaboration with Pfizer.
Testing ATM-AVI
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.
The proposed administration of ATM-AVI for enrolled patients was a loading dose, immediately followed by a maintenance infusion. From day two onwards, the dose was raised. This treatment was continued for five to fourteen days, deemed appropriate by the investigator. If the patients showed significant clinical improvement, all study therapies were discontinued. Assessment of clinical response was made at End-of-Treatment (EOT), Test-of-Cure Visit (TOC) and Late-Follow-Up (LFU) points.
Study team members
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Alison Luckey
Study Physician / EFPIA leader / Pfizer
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Barbara Evans
LAB - Other, please specify / EFPIA / Pfizer
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Boudewijn Jonge, de
LAB - Other, please specify / EFPIA / Pfizer
Study level information
- Study NO N/A
- Study Name REJUVENATE
- Study Type Phase II
- Study Status Database Lock
- Enrollment Period 05/16 - 09/17
- Total subjects planned 40
- Total subjects screened 40
- Total subjects enrolled 34
- Total subjects completed 24
Study timeline
- Light blue
- Preparation phase
- Dark blue
- Trial period
Country level information
planned 12
enrolled 2
completed 1
planned 12
enrolled 3
completed 0
planned 20
enrolled 29
completed 24
Related updates
EMA recommends Marketing Authorization for ATM-AVI
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