The Base of COMBACTE's Future

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Current status: Active Recruiting
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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.

The phase II REJUVENATE project (WP2A) reported the PK and safety of ATM-AVI  in a representative patient population and confirmed the dose regime for Phase III program.  WP2B is a pivotal regulatory submission global phase III study (REVISIT) which will further establish the efficacy and safety of treating a representative population of serious Gram-negative bacterial infections with ATM-AVI. Pfizer, as sponsor, and COMBACTE-CARE via WP2B are conducting this study in co-development with AbbVie (formerly Allergen) and co-funded by the US Biomedical Advanced Research and Development Authority (BARDA).

Current Status

Globally 27 countries,  (11 COMBACTE CARE countries) are participating in the REVISIT study. Currently site initiation is underway following completion of the first in a series of virtual investigator meetings held in June 2020.  First subject is enrolled into the study, at site #1176 (Czech Republic), on 02 Sep 2020.

Study team members

  • Alison Luckey

    EFPIA leader / Pfizer

  • Clara Rosso Fernandez

    Sr. Project Manager / Academic / Hospital Universitario Virgen del Rocío

  • Clothilde Zimmerman

    Project Manager / EFPIA / Pfizer

Study level information

General information
  • Study NO NCT03329092
  • Study Name REVISIT-C3601002
  • Study Type Phase III
  • Study Status Planned
  • Enrollment Period 08/20 - 01/22
Enrollment
  • Total subjects planned 144
  • Total subjects screened 9
  • Total subjects enrolled 9
  • Total subjects completed 0

Study timeline

Light blue
Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 5
Sites activated 0
Bulgaris
Subjects
planned
15
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
Sites planned 3
Sites activated 2
Croatia
Subjects
planned
6
Subjects
enrolled
2
Subjects
completed
0
Subjects completed
0.0%
Sites planned 4
Sites activated 2
Czech Republic
Subjects
planned
9
Subjects
enrolled
2
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 6
Sites activated 0
Subjects
planned
11
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
Sites planned 4
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 3
Spain
Subjects
planned
28
Subjects
enrolled
5
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 12
Sites activated 0
Ukraine
Subjects
planned
21
Subjects
enrolled
0
Subjects
completed
0
Subjects completed
0.0%
02/12/2020

Immense Commitment in REVISIT

29/10/2020

Trial stories: REJUVENATE, COMBACTE’s first interventional clinical trial