REVISIT Completes Recruitment
In November 2022 COMBACTE-CARE received approval for a 6 month no-cost extension from 31st December 2022 till 30th June 2023 to support completion of the WP2B* ATM-AVI Phase III study (REVISIT). Completion of the project by this date is key to support the final financial reporting requirements by the consortia during December 2023.
WP2B continues to make tremendous progress to meet these revised project deadlines and the New Year (13th January 2023) saw completion of the study recruitment. This goal was achieved through the contribution of 138 global sites, 68 of which were from the COMBACTE CLIN-Net network. 422 patients have been randomised globally, 200 from the COMBACTE CLIN-Net network. The study is on track to achieve a final clinical study report later this year.
The participation of our COMBACTE CLIN-Net network and academic lead partners, Yehuda Carmeli, Mical Paul, George Daikos, and Jose-Miguel Cisneros, have been critical to the success of this project, and we wish to recognize the exceptional achievements of some of our highest enrollers in the COMBACTE network around the world.
| Country | # Enrolled |
| Ukraine | 70 |
| Spain | 53 |
| Turkey | 25 |
| Czech Republic | 20 |
| Bulgaria | 8 |
| Romania | 7 |
| Greece | 7 |
| Italy | 5 |
| Hungary | 0 |
| Country | Site / PI | Total Enrolled |
| Spain | 1135 / de La Torre Cisneros | 23 |
| Ukraine | 1247 / Gumenchuk | 19 |
| Ukraine | 1207 / Titov | 17 |
| Spain | 1133 / Jimenez Rodriguez | 17 |
| Ukraine | 1214/Pyptiuk | 11 |
| Turkey | 1143/Aksoy | 10 |
*A prospective, randomised, multicenter, assessor-blind, parallel group, comparative study to determine the efficacy, safety, and tolerability of aztreonam-avibactam for the treatment of serious infections due to metallo-β-lactamase producing Gram-negative pathogens (REVISIT).
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