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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LAB-Net National Coordinators Meeting

07/12/2016: LAB-Net organized its first LAB-Net National coordinators’ meeting In Antwerp, Belgium. National coordinators from 10 countries (Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Germany, Kosovo, Macedonia, Montenegro, the Netherlands and Spain) joined the event. 
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Good Clinical Practice

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

LAB-Net National Coordinators Meeting

LAB-Net organized its first National coordinators meeting. National coordinators from 10 countries (Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Germany, Kosovo, Macedonia, Montenegro, the Netherlands and Spain) joined the event which was held in Antwerp, Belgium on 28th June, 2016. The participants had the opportunity to find out more about the structure of COMBACTE and its two network pillars, CLIN-Net and LAB-Net, as well as to present their own national laboratory networks.  More information was given to the LAB-Net national coordinators about the future plans and goals of LAB-Net, as well as the upcoming activities in 2016. Roles and responsibilities of the national coordinators were defined followed by a discussion on the topic. The participants were also briefed on the External quality assessment programme of LAB-Net and the plans to deliver Good clinical laboratory practice training to the local labs in the network. 

COMBACTE-NET

Study Update REJUVENATE

Since May 19th, a total of 6 patients have been enrolled in the REJUVENATE Study. Five patients were treated with ATM-AVI, with one screening failure. So far, all patients were enrolled in Spain at the University Hospital Virgen del Rocío, Seville (J. M. Cisneros Herreros & M.J. Hernández-Rodríguez), the Hospital Universitario Virgen Macarena, Seville (J. Rodríguez-Baño & L. Tallón-Aguilar), and the University of Cordoba (J. de la Torre Cisneros). As of now, 13 of 22 participating sites are initiated. Six sites are active and pre-screening and enrolling patients:  1 in France, 2 in Germany, and 3 sites in Spain. The remaining sites await activation following contract execution, and/or will be initiated and activated in July and August. The WP2A team is now working on achieving the next major milestones for REJUVENATE - the early safety and PK assessment of the first 10 patients that complete all study assessments.  This review will support dose selection for the remainder of the Phase II study, including an appropriate dose for inclusion of patients with moderate renal impairment and confirmation of the dose to take forward into the Phase III study (WP2B). At the current recruitment rate inclusion of the 10th patient is expected in August, and 10-patient-review during September 2016.

COMBACTE-CARE

RESCUING: all 1000 cases collected!

Due to the hard work of all the participating sites, site staff, monitors and the study team, all the 1000 cases required for the RESCUING study have been collected. This Marks a very important milestone in this study.

The number of collected cases by the participating countries are depicted in the table below.


Country

#of sites

#of cases collected

Spain

3

162

Greece

2

89

Bulgaria

2

103

Romania

2

140

Turkey

2

100

Hungary

3

98

Israel

3

185

Italy

3

125

Total

20

1002

 

The majority of close-out visits are now scheduled and the goal is to obtain the database lock by the end of July.  Going forward, the plan is to analyze the data over the summer with a target completion date by the end of September 2016. It is hoped that the study report will be available during October 2016.

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

COMBACTE-MAGNET

DRIVE-AB Conference

Beginning of this month, on Thursday June 2nd, IMI's DRIVE-AB, part of the ND4BB program held the “Stimulating innovation, sustainable use and global access to antibiotics” conference in Amsterdam. DRIVE- AB is a public-private consortium developing new economic models to stimulate antibiotic innovation and ensure global access to and sustainable use of antibiotics.

Global leaders agree on the need to maintain a steady supply of new antibiotics for all as a critical part of the strategy to address antibiotic resistance and that new reward models are necessary to achieve this goal. While basic frameworks have been proposed, the DRIVE-AB consortium seeks a level of granularity that other initiatives have not, moving beyond discussions to concrete plans for policy implementation.
DRIVE-AB shared its preliminary proposals at the event, which attracted more than 180 high-level decision-makers and policy experts, economists, regulatory and public health experts and representatives of pharmaceutical companies and research institutions from around the world. 

The conference featured keynote speakers and panellists from the World Health Organization, the European Commission, the European Investment Bank, and the US Centers for Disease Control and Prevention, to name a few. The participation of a diverse group of stakeholders at the conference illustrates the level of global interest in the outcomes of DRIVE-AB, and will help the consortium secure the buy-in of stakeholders who can help to implement new incentive policies.

The consortium is pleased to have brought important stakeholders together to explore solutions to antibiotic innovation, and the robust discussions will help DRIVE-AB to deliver recommendations in 2017 that have a high probability of success. A full conference summary outlining the key messages and outcomes of the meeting in more detail will be published in the coming months.

This conference was generously supported by the Dutch Ministry of Health, Welfare and Sport. Read more on DRIVE-AB.


COMBACTE

 

Events

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
 

Magazine

 
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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