REVISIT is one of the studies in COMBACTE that offers an important contribution in the battle against AMR. With academia and pharma shoulder-to-shoulder on the frontline, REVISIT studied the efficacy and safety of a fixed combination of aztreonam and avibactam (ATM-AVI) in a Phase III randomised, open-label, comparative clinical trial.
We spoke with Dr. José Miguel Cisneros Herreros (Hospital Universitario Virgen del Rocio, Seville, Spain) and Pfizer’s Lisa Grimsditch and Rienk Pypstra about the impact of REVISIT.
“If successful, REVISIT could optimise the care of patients with complicated intra-abdominal infections and hospital acquired pneumonias”, says José Miguel. He adds: “The design, implementation and application of the study protocol has the potential to improve the care of future patients, the communication flows including the detection of potential candidates, the systematic sampling for microbiological diagnosis, and more timely administration of antimicrobials.”
New antibiotic combination: BL/BLI
Rienk says: “We set out to demonstrate the activity of this new Beta-Lactam/Beta-Lactamase Inhibitor (BL/BLI) combination, and we have now completed patient recruitment. We were able to do so with the collaboration that was on offer through this consortium.” If the study demonstrates the safety and efficacy of this new BL/BLI combination, and if approved, ATM-AVI will allow physicians to have a simple and straightforward solution to a problem that currently requires various combinations of antibiotics. Rienk: “This would be a huge benefit that REVISIT will have brought to the community.”
Solid collaboration every step of the way
“The collaboration between academia and pharma was one of the most outstanding features of the REVISIT clinical trial, and in my opinion has been
key to its success”, says José Miguel, who cites increased commitment and motivation among the investigators as a factor leading to successful patient recruitment. It’s a similar story from Pfizer’s perspective who outlined that a much closer collaboration, frequent contact and working together as partners made for a different mindset and an evolved relationship. According to Lisa, this collaboration is a really strong theme running throughout COMBACTE-CARE, not just in science and clinical efforts, but also in project management and management boards. “Solid collaboration was there every step of the way leading to everyone coming together to solve problems.”
Rare but highly resistant
For Pfizer, a COMBACTE-CARE industry partner, testing the safety and efficacy of ATM-AVI was paramount. Antimicrobial resistance (AMR) is one of the biggest threats to global health today and urgently needs to be addressed, a concern that Pfizer takes very seriously. Rienk: “Patients and clinicians need new therapeutic modalities to treat infections caused by these rare but highly resistant pathogens. It’s why we are involved.”
“The data quality, and future patient benefits were at the forefront of the minds of all involved”
Selecting the right sites is key
Aside from the pending clinical study results, much has already been learnt from the REVISIT study, including how important selecting the right sites and investigators is, and how key it is for efficient and high quality recruitment. The fulfilment of the target sample size despite the pandemic is a major achievement. For José Miguel, “the most important benefit has been the creation of a multidisciplinary team, with an active involvement of surgeons, nurses, microbiologists, pharmacists and infectologists, along with the challenge of carrying out the project in the hospital and leading it in our country.”
Unique site relationship-building opportunities
Rienk says that Spain was a particularly good example in relation to recruiting patients who are difficult to find for a combination of reasons. Collaboration between pharmaceutical companies and academic centres is vital and allows for knowledge sharing and encourages unique site relationship-building opportunities. Rienk: “Together with our academic partners we selected high-potential sites, and offered support to help ensure high quality standards. With this endeavour COMBACTE-CARE has established a high-quality clinical trial network in Europe: European Clinical Research Alliances on Infectious Diseases (Ecraid).” Lisa believes that the willingness of the academic partners was inspiring. “A specific example is the support for the study sites, which was designed to provide investigators with support through a 24/7 global support line with national leads offering advice. It exemplified how people came together to ensure that the study progress, the data quality, and future patient benefits were at the
forefront of the minds of all involved.”