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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RESCUING: all 1000 cases collected!

06/30/2016: Due to the hard work of all the participating sites, site staff, monitors and the study team, all 1000 cases required for the RESCUING study have been collected. This Marks a very important milestone in this 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

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-GLOBAL

ASPIRE-ICU Study Update

ASPIRE-ICU is a prospective, observational, multicenter, cohort study nested within routine surveillance among ICU patients in Europe. This study estimates the incidence of S. aureus and P. aeruginosa ICU-acquired pneumonia and assesses its association with patient-related and contextual factors.

Currently, 27 sites across 10 countries have been selected to participate in the ASPIRE-ICU study, representing Northern, Eastern, Southern and Western European sub regions. Ten sites have been initiated in the Netherlands, Spain, Serbia, Turkey and Estonia. As for enrollment, 1253 patients are in the surveillance population and of these surveillance patients, 135 subjects are enrolled in the study cohort population (n=2000 to complete). 

In addition to site start-up activities, the study team completed a substantial protocol amendment including changes to the inclusion and exclusion criteria to boost enrollment in the study cohort. All initiated sites now have ethical approval of the amended protocol. The study team is also working towards a data cut by year end to support future trial design.  

If your site is interested in participating in the ASPIRE-ICU study, please contact our Site Selection Coordinator, Nienke Cuperus at N.cuperus@umcutrecht.nl. Any other questions, please contact the ASPIRE-ICU Project Manager, Daniel Prins, at D.R.Prins-2@umcutrecht.nl

 


Country

# sites enrolling in study cohort

# surveillance patients

# study cohort subjects

Netherlands

2

873

92

Spain

3

312

37

Serbia

1

57

6

Total

 

 

135

 

COMBACTE-NET

RESCUING Study Update - June

Due to the hard work of all the participating sites, site staff and monitors, the RESCUING study is approaching its target inclusion of 1000 patients. Currently, 20 sites are still actively enrolling cases and thus far over 950 cases been entered into the eCRF. Due to ethical approval delays, some sites could only recently initiate their case entries. In the table below the number of enrolled cases are depicted for each participating country. 

 

Country

#of sites

#of cases

started

# of cases

completed

Spain

3

164

160

Greece

2

89

87

Bulgaria

2

103

83

Romania

2

126

123

Turkey

2

100

98

Hungary

2

54

12

Israel

3

184

184

Italy

3

109

102

Total

19

929

849

 

The close-out visits will be scheduled within the next few weeks and the goal is to obtain the database lock by the end of July. The plan is to analyze the data over the summer with a completion date for this activity in September 2016. It is hoped that the study report should be available by October 2016. Thus far, the study would appear to be recruiting to time and target.

Since cUTI’s impose a high burden in both patients and health care systems and little data is available on the cost of cUTI’s, the participating sites are invited to complete an online questionnaire on the unit costs of health care resources and services for the diagnosis, treatment and supportive care related to the management of cUTI. Based on this information, the cost per cUTI as well as the total national burden of cUTI's in each participating country can be estimated.

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

 

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
 
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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