The Last of COMBACTE: COMBACTE-NET

First One In, Last One Out

COMBACTE-NET was the first project that was launched as part of Innovative Medicines Initiative’s (now Innovative Health Initiative) New Drugs for Bad Bugs (ND4BB) programme, which aims to counter antimicrobial resistance by strengthening everything from basic science and drug development to clinical testing and finding new business models.

European Clinical Research Network

The COMBACTE-NET project was tasked specifically with building a European network of research clinics, labo­ratories, and investigators that can be utilised to rapidly evaluate novel antimicrobial agents. In addition, COMBACTE-NET was set up to employ that newly created network by conduc­ting various high-quality clinical trials that tested the safety and efficacy of some specific candidate drugs.

COMBACTE-NET’s networks have delivered on their promise. They have proved capable of conducting not just observational studies but Phase I, Phase II and Phase III clinical trials as well, even in complicated clinical settings such as mechanically ventilated patients in intensive care.

COMBACTE-NET created a vast and powerful pan-European infrastructure that is able to rapidly evaluate potential novel antimicrobials. That infrastructure includes CLIN-Net, a network of over 1,200 hospitals that can quickly and reliably recruit patients for inclusion in multinational, multi-centre trials. It also includes LAB-Net, a network of over 900 microbiology laboratories that can quickly deliver reliable, standardised data on microbial strains and their resistance against existing antibiotics.

Both these networks now form a sustainable antimicrobial resistance clinical research network and have been active in and are a part of Ecraid – the European Clinical Research Alliance on Infectious Diseases – the result of COMBACTE’s 12-year mandate.

Highlights

COMBACTE-NET proved effective, for example, in a Phase II study of suvratoxumab, a novel monoclonal antibody targeting alpha toxin from the Staphylococcus aureus bacteria to protect highly vulnerable, critically ill patients from developing life-threatening infections.

These capabilities and infrastructure created by COMBACTE-NET were utilized effectively for other projects such as the Phase II study of gremubamab, an antibody against Pseudomonas aeruginosa, also studied in critically ill patients at risk for serious life-threatening infections.

Another one of COMBACTE-NET’s key contributions was generating data in support of novel methodological trial approaches (for example, the use of composite endpoints).

Those data informed discussion with regulators about how to use innovative study designs to make future clinical trials more time-efficient. COMBACTE-NET’s broad-based infrastructure even proved extremely useful outside the realm of novel antimicrobials.

During the COVID-19 pandemic, rapid molecular diagnostic capabilities, strengthened across Europe through the CLIN-Net and LAB-Net frameworks, proved critical in the fight against SARS-CoV-2.

Scientific Papers

Publishing the results of the clinical trials in COMBACTE-NET is a clear demonstration of  the value of the longstanding and productive public-private partnership.

All these papers can be found in COMBACTE’s Publication Library.

Together, the 46 pharmaceutical and academic partners in the project have delivered groundbreaking results and fostered a culture of mutual learning. They have contributed immensely to making an impact in society, but most notably ensuring the sustainability of these efforts.

The peer-reviewed papers are fundamental in driving medical progress and improving patient care.  Most importantly they strengthen the exchange of knowledge at a European, but also at an international level. Making these outcomes open to the scientific community ensures informed clinical guidelines, shaping public health strategies and driving future research.

Ultimately, they strengthen the foundation of evidence-based medicine, providing a sustainable framework for advancing medical research and ensuring that the global healthcare community continues to improve health outcomes worldwide.