Combatting Bacterial
Resistance in Europe

About COMBACTE

Antimicrobial resistance is a growing problem worldwide, and with few new drugs making it to the market, there is an urgent need for new medicines to treat resistant infections.
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First Patient in REJUVENATE Study

05/29/2016: It is with great pleasure that we announce the recruitment of the first patient in COMBACTE-CARE’s REJUVENATE study.
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GCP

To assure a European research infrastructure performing high-quality clinical trials related to antibiotic resistance, all CLIN-Net participants are required to comply with ‘Good Clinical Practices’ (GCP).
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Highlights

First Patient in REJUVENATE Study

It is with great pleasure that we announce the recruitment of the first patients in COMBACTE-CARE’s REJUVENATE study. José Miguel Cisneros Herreros from the University Hospital Virgen del Rocio, Jesús Rodríguez-Baño and Luis Tallón's team from Hospital Universitario Virgen Macarena, enrolled the first patients on the 19th and 26th of May respectively.

REJUVENATE is a prospective, open-label, multicenter, phase IIa study to determine the pharmacokinetics, safety and tolerability of aztreonam-avibactam (ATM-AVI) in hospitalized adults with complicated intra-abdominal infections (cIAI). A total of 40 patients will be enrolled in 3 European countries (France, Germany, Spain).  ATM-AVI is being developed by AstraZeneca for the treatment of serious bacterial infections due to susceptible Gram-negative bacteria, including metallo-β-lactamase producing multi-drug resistant pathogens.  The first study site, the University Hospital Cologne, Germany, was initiated on March 30th with additional sites activated in Germany, Spain and France during April and May.  

Clinical Trials Centre Cologne (CTCC), of the University of Cologne was selected to act as an academic research organization (ARO) for the REJUVENATE study. COMBACTE-CARE’s  REJUVENATE  is the first study across the Innovative Medicines Initiative (IMI), New Drugs4Bad Bugs  programme, with an academic partner ARO providing study operations.  

COMBACTE-CARE, a project with 18 academic and 3 pharmaceutical partners, led by AstraZeneca as the coordinator and The University of Utrecht as the managing entity, aims to better understand the clinical management and outcomes of hospitalized patients with carbapenem resistant Enterobacteriaceae (CRE)  infections, to analyse clinical and microbiological data to provide new insights for novel clinical trial designs, and to make recommendations for the development of novel antibiotics to treat resistant infections.

Seamus O'Brien, AstraZeneca EFPIA Coordinator


COMBACTE-CARE

RESCUING Study Update

20 sites across 8 countries (i.e. Bulgaria, Greece, Hungary, Israel, Italy, Romania, Spain and Turkey) were initiated following web-based investigator meetings and online trainings performed in November and December 2015. Approximately 40-60 consecutive cases of cUTI are to be included from each site to attain a target recruitment of 1000 patients. 

The RESCUING study is a retrospective observational study to assess the clinical management and outcomes of hospitalized patients with complicated urinary tract infections (cUTI) in European countries with a high prevalence of multidrug resistant (MDR) gram-negative bacteria. The results of this study will provide a better understanding of the clinical management of hospitalized patients with cUTI due to MDR gram-negative bacteria.   

The first case was enrolled on December  23rd, 2015. Currently, 18 sites are actively enrolling cases and over 500 cases have now been entered into the eCRF. The deadline for data completion was 31st May 2016. The data will be analyzed starting in September 2016 and the study report should be available by December 2016. Thus far, the study appears to be on track.  

If you have any questions or comments, please feel free to contact the study lead Miguel Pujol using the following email address: mpujol@bellvitgehospital.c

 

Country

Number of sites

Number of cases started

Number of cases completed

Spain

3

114

96

Greece

2

64

60

Bulgaria

2

19

16

Romania

2

65

63

Turkey

2

70

55

Hungary

2

19

10

Israel

3

93

86

Italy

2

27

23

Total

18

471

409

 


COMBACTE-MAGNET

Building Sustainability for AMR and EID Research in Europe

Today 9 AMR and ID experts met in Amsterdam to discuss the development of a new European clinical research network for AMR and Emerging ID (working name ECRAID). This initiative stems from the IMI-funded COMBACTE consortia and the FP7-funded PREPARE project. COMBACTE’s mission is to improve the quality and efficiency of clinical trials with new antimicrobial agents in Europe. To that aim it is establishing a clinical and laboratory network (CLIN-Net and LAB-Net). PREPARE’s mission is to prepare Europe for the next pandemic with an emerging ID.  Both projects are still funded for the next years, but both projects also aim to create sustainability of their activities. The leadership of both projects agreed to pursue this ambition together. 
 

Today was the first meeting to achieve this. The purpose of this new organization will be something like “To reduce the impact of infections on society”, and the vision will be something like “We make this possible by efficiently generating rigorous evidence for improved diagnostics, prevention and treatment of infections and to better respond to EID threats. This is facilitated by a European multidisciplinary clinical research network and innovative research approaches.” A long way to go, but the first steps have been set. We will keep you posted.


Marc Bonten, UMC Utrecht, Academic Coordinator

General

DRIVE-AB Conference on Sustainable Development and use of Antibiotics

DRIVE-AB is one of seven projects in the Innovative Medicines Initiative’s (IMI) New Drugs for Bad Bugs (ND4BB) programme, and is focused on the economic and societal aspects of antibiotic R&D. New incentives, coupled with provisions for sustainable use and equitable access policies, are needed to stimulate antibiotic innovation. The interdisciplinary team researches and develops such new economic models to stimulate the desired antibiotic innovation. The project is based on an extensive stakeholder engagement process that includes policy- and decision-makers, companies and academic institutions, medical community, regulators, health technology assessment and reimbursement institutions, and civil society.

DRIVE-AB will hold a high-level conference entitled ‘Stimulating innovation, sustainable use and global access to antibiotics’ on the 2nd June in Amsterdam, the Netherlands. The goal of the event is to bring together policy makers, regulatory and public health experts, and economists to identify and evaluate reward models that are feasible, practical and can be implemented globally. This conference, generously funded by the Government of the Netherlands will bring together about 150 decision-makers and policy influencers from around the world to explore current and proposed efforts to address the need for new antibiotics. 

The main goal of the meeting is to move beyond discussions and identify key policies that can be implemented globally to both stimulate the innovation of critically-needed new treatments and ensure their availability and sustainable use. A smaller policy meeting the next day will capitalize on the presence of key high-level policy-makers and stakeholders that have attended the DRIVE-AB conference on 2 June and will build on those discussions. This follow-up meeting will focus on DRIVE-AB’s preliminary work on new economic models, share DRIVE-AB’s preliminary technical analysis of the models currently identified as most promising and receive feedback, identify implementation challenges and knowledge gaps, and develop a roadmap for the remaining 18 months of the project. Input from the conference and the policy meeting will help inform DRIVE AB’s policy recommendations to the European Commission. 

Read more on DRIVE-AB.



 

 


General

 

Events

28jun

LAB-Net National Coordinators Meeting, Antwerp, Belgium

Duration: One Day Event
01sep

Annual Meeting STAT-Net, Manchester, England

Duration: One Day Event
22sep

Face to Face GCP Training, Athens, Greece

Duration: 3 Days
12oct

CLIN-Net National Coordinators Meeting, Schiphol, The Netherlands

Duration: One Day Event
 
This research project receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115523 | 115620 | 115737 resources of which are composed of financial contribution from the European Union Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution.
     
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