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REJUVENATE
Current status: Database Lock
combacte-care

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.

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.

Study information

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.

Study team members

  • Alison Luckey

    Study Physician / EFPIA leader / Pfizer

  • Angela Steinbach

    Project Manager / Academic / UKK Uniklinik Köln

  • Barbara Sowinski

    Medical Writer / EFPIA / Pfizer

Study level information

General information
  • Study NO N/A
  • Study Name REJUVENATE
  • Study Type Phase II
  • Study Status Database Lock
  • Enrollment Period 05/16 - 09/17
Enrollment
  • Total subjects planned 40
  • Total subjects screened 40
  • Total subjects enrolled 34
  • Total subjects completed 24

Study timeline

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Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 6
Sites activated 5
France
Subjects
planned
12
Subjects
enrolled
2
Subjects
completed
1
Subjects completed
8.3%
Sites planned 6
Sites activated 5
Germany
Subjects
planned
12
Subjects
enrolled
3
Subjects
completed
0
Subjects completed
0.0%
Sites planned 10
Sites activated 10
Spain
Subjects
planned
20
Subjects
enrolled
29
Subjects
completed
23
Subjects completed
115.0%