Reflections On COMBACTE-NET

The project

Nathalie Seigneuret, IHI Scientific Project Manager for COMBACTE: “COMBACTE-NET was among the very first projects that were launched as part of IMI’s 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. 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. Today, ten years after its work commenced, it can safely be concluded that the public-private consortium has delivered on its goals.”

The results

“First and foremost, the project did create a vast and powerful pan-European infrastructure that is able to rapidly evaluate potential novel antimicrobials” Nathalie says. “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.”

Hasan Jafri, Management Board Member and EFPIA Coordinator for COMBACTE-NET: “COMBACTE-NET has changed the paradigm for clinical research in infectious diseases, not only in Europe but globally. Infectious disease research had long lacked high-quality networks of accomplished clinical research centers and laboratories, and COMBACTE-NET fulfilled that unmet need.”

Nathalie adds: “Tying together these two capabilities is essential for conducting trials in which critically ill patients need to be diagnosed, recruited, appropriately treated, monitored, and evaluated. 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 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 lifethreatening 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.”

Nathalie adds: “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. In all, COMBACTE-NET’s numerous impacts have been substantial, and thanks to Ecraid they will continue to be felt for years to come.”