COMBACTE-NET
Combatting bacterial resistance in Europe – networksThese networks will enable the collection of data required for accurately identifying clinical needs and coming up with ideas for developing effective new antibacterial treatment options. Importantly, the networks will form the backbone for all clinical studies within the wider ND4BB program.
COMBACTE-NET aims to:
- provide a large network for rapid evaluation of novel treatment strategies;
- generate innovative trial designs to facilitate the registration of novel antibacterial agents;
- design and validate tests to support the diagnosis of patients, identify the most appropriate treatments, and monitor the patient’s response
Pan-European Networks
One of the key outcomes of COMBACTE-NET is a high-quality European clinical trial and laboratory network in which new antibacterial drugs can be evaluated for the treatment and prevention of infections caused by multi-resistant bacteria. Over 760 laboratories and over 990 clinical trial sites all over Europe are already interconnected. These networks will enable the collection of data required for accurately identifying clinical needs and coming up with ideas for developing effective new antibacterial treatment options. An important aspect of the networks is that they will form the backbone for all clinical studies within the wider ND4BB program.
CLIN-Net
A network of clinics and hospitals offering access to fast numbers of patients and with the capability to perform high-quality clinical trials.
LAB-Net
A network of microbiology laboratories delivering high-quality and standardized information on microbial strains and antibiotic resistance.
STAT-Net
A network of academic and industry experts on clinical trial design working to optimize the design of Phase II and Phase III clinical trials.
Clinical trials
The following clinical studies are being/have been executed within COMBACTE-NET:
SAATELLITE
A Phase II, randomized, double-blind, placebo-controlled trial to test the safety and efficacy of MEDI4893, a monoclonal antibody against S. aureus Alpha Toxin, developed to prevent nosocomial pneumonia due to S. aureus in adult ICU patients. This compound is being developed by AstraZeneca.
ASPIRE-ICU
A prospective, observational, epidemiologic cohort study of ICU patients to determine the incidence and determinants of healthcare associated infections caused by S. aureus or P. aeruginosa. This study is being performed in collaboration with AstraZeneca.
ASPIRE-SSI
A prospective, observational, epidemiologic cohort study of surgical patients to determine the incidence and determinants of S. aureus healthcare associated infections.
ANTICIPATE
A prospective observational cohort study of patients receiving antibiotic treatment during hospitalization to estimate the incidence of C. difficile infections, antibiotic-associated diarrhea, and changes in the diversity and composition of the intestinal microbiota. Performed in collaboration with Da Volterra.
ARTHR-IS
A retrospective, observational study, to provide estimates of the rate of S. aureus prosthetic joint infections (SA-PJI), hospitalizations and surgical procedures related to SA-PJI, predictors for such infections and the factors influencing therapeutic failure. This study is carried out in collaboration with GlaxoSmithKline.
EXPECT
A feasibility study to assess parameters for an ExPEC10V Phase III clinical efficacy trial in adults of 60 years and older. The study will be performed in collaboration with Janssen.
HONEST-PREPS
A prospective, observational, multicenter cohort study. The study population are the patients admitted to an intensive care unit at risk for hospital acquired and ventilator associated pneumonia.
Clinical trials for candidate drugs
- Suvratoxumab (formerly MEDI4893) is a monoclonal antibody from AstraZeneca, that could protect mechanically ventilated patients against infections with Staphylococcus aureus, preventing bacterial toxins from damaging their organs and tissues;
- Da Volterra’s DAV132 is a promising new therapeutic agent for the prevention of serious Clostridium difficile infections. In the ANTICIPATE study, it is tested for safety and pharmacokinetics. In essence, it adsorbs small molecules such as antibiotics, preventing bacteria present in the gut from harming the patient;
Management Board
From left to right: Dr. Bruno François (CHU Limoges), Prof. Dr. Marc Bonten (UMCU), Dr. Venanzio Vella (GSK), Dr. Hasan Jafri (AstraZeneca), Prof. Dr. Stephan Harbarth (HU Genève), Prof. Dr. Herman Goossens (UAntwerpen), Peter Hermans (Janssen)
Project Management Office
From left to right: Claire-Marie Martis (UMC Utrecht), Dr. Ram Venkatachalam (UMC Utrecht), Marie-Noëlle Bouverne (Da Volterra), Dr. Drieke Vandamme (CHU Limoges), Dr. Ron de Winter (UMC Utrecht), Elodie Pfender (CHU Limoges), Kristin Kopasz (AstraZeneca), Terramika Bellamy (AstraZeneca)
