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Trials
Current status: In preparation
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REVISIT

Determining efficacy and safety of ATM-AVI for treating serious infections caused by Gram-negative, carbapenem-resistant, bacteria. REVISIT – Revisiting serious bacterial infection with innovation is conducting a Phase III randomized, open-label, comparative clinical trial to determine the efficacy and safety of aztreonam-avibactam (ATM-AVI). ATM-AVI is intended for treating serious bacterial infections caused by Gram-negative bacteria, including metallo-beta-lactamase-producing MDR pathogens, for which there are limited or no treatment options.

Determining efficacy and safety

In the Phase II REJUVENATE project (WP2A), the pharmacokinetics and safety of ATM-AVI are being investigated. In WP2B this research has progressed into a Phase III clinical trial (REVISIT) to determine the efficacy and safety of treating a representative population of serious Gram-negative bacterial infections with ATM-AVI.

Regulatory approval

Pfizer, as sponsor, and COMBACTE-CARE via WP2B are conducting a global study in partnership with, and co-funded by the US Biomedical Advanced Research and Development Authority (BARDA). REVISIT will be a pivotal Phase III study for the ATM-AVI regulatory submission package.

Current status

Globally 27 countries, 11 in Europe are participating in the REVISIT study. Regulatory and Ethics submissions are ongoing in most of the countries. To date, Clinical Trial Application approvals have been obtained in 10 countries globally, including 4 in Europe, and the study is now entering the patient randomization phase. *Recruitment has been temporarily suspended in study C3601002 due to a delay in investigational product availability.  Revised study timelines to be posted upon IMI approval.

Study team members

  • Alison Luckey

    EFPIA leader / Pfizer

  • Boudewijn Jonge, de

    EFPIA / Pfizer

  • Clara Rosso Fernandez

    Sr. Project Manager / Academic / Virgen del Rocio University Hospital

Study level information

General information
  • Study NO NCT03329092
  • Study Name REVISIT-C3601002
  • Study Type Phase III
  • Study Status Planned
  • Enrollment Period 04/18 - 07/19
Enrollment
  • Total subjects planned 144
  • Total subjects screened 0
  • Total subjects enrolled 0
  • Total subjects completed 0

Study timeline

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Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 6
Sites activated 0
Bulgaris
Subjects
planned 15
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 3
Sites activated 0
Croatia
Subjects
planned 6
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 4
Sites activated 0
Czech Republic
Subjects
planned 9
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 7
Sites activated 0
Greece
Subjects
planned 17
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 2
Sites activated 0
Hungary
Subjects
planned 4
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 5
Sites activated 0
Subjects
planned 11
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 5
Sites activated 0
Italy
Subjects
planned 11
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 5
Sites activated 0
Romania
Subjects
planned 9
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 13
Sites activated 0
Spain
Subjects
planned 28
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 5
Sites activated 0
Turkey
Subjects
planned 11
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%
Sites planned 9
Sites activated 0
Ukraine
Subjects
planned 21
Subjects
enrolled 0
Subjects
completed 0
Subjects completed
0.0%

Related updates

October 03, 2020

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April 05, 2020

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The multidisciplinary team of the Virgen del Rocío University Hospital in Seville – one of COMBACTE-CARE’s top recruiters in the Aztreonam...

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