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REVISIT
Current status: In preparation
combacte-care

Determining efficacy and safety of ATM-AVI for treating infections caused by Gram-negative bacteria

REVISIT – Revisiting serious bacterial infection with innovation. WP2B is a Phase III randomized comparative clinical trial to determine the efficacy and safety of aztreonam-avibactam (ATM-AVI), an extremely effective combination of two known antibiotics. It is intended for treating serious bacterial infections caused by Gram-negative bacteria, including metallo-beta-lactamase-producing MDR pathogens.

Determining efficacy and safety

In the REJUVENATE project ATM-AVI is already being Phase II tested for pharmacokinetics and safety. In WP2B this research is entering the next stage. A Phase III clinical trial will determine the efficacy and safety of treating Gram-negative bacterial infections with ATM-AVI.

Regulatory approval

WP2B is a global study carried out together with Pfizer and funded in part by the US Biomedical Advanced Research and Development Authority (BARDA). In the event of positive outcomes of this Phase III research, Pfizer will be able to apply for regulatory approval of ATM-AVI.

Study team members

  • Alison Luckey

    Medical Director / EFPIA leader / Pfizer

  • Annemarie Engbers

    Sr. Project Manager / Academic / UMC Utrecht

  • Boudewijn Jonge, de

    Clinical Microbiologist / EFPIA / Pfizer

Study level information

General information
  • Study NO NCT03329092
  • Study Name REVISIT- ATM-AVI study
  • Study Type Clinical Study Phase III
  • Study Status Planned
  • Enrollment Period 04/18 - 07/19
Enrollment
  • Total subjects planned 140
  • Total subjects screened 0
  • Total subjects enrolled 0
  • Total subjects completed 0

Study timeline

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Preparation phase
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Trial period

Country level information

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Sites planned 6
Sites activated 0
Bulgaris
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0
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0
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Subjects completed
0.0%
Sites planned 3
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Croatia
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0
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Sites planned 4
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Czech Republic
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Sites planned 7
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Greece
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Sites planned 2
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Hungary
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Sites planned 5
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0
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Sites planned 5
Sites activated 0
Italy
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0
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0
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0
Subjects completed
0.0%
Sites planned 5
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Romania
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Subjects completed
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Sites planned 13
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Spain
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0.0%
Sites planned 5
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Turkey
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0
Subjects completed
0.0%
Sites planned 9
Sites activated 0
Ukraine
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