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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AiCuris Initiates Clinical Development of AIC499

01/05/2017: AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious disease and partner in COMBACTE-MAGNET, today announced the start of a new clinical program with AIC499.
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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

AiCuris Initiates Clinical Development of AIC499

AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, today announced the start of a new clinical program with AIC499, an innovative beta-lactam antibiotic against a broad range of multidrug-resistant (MDR) Gram-negative bacteria in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Read full press release here.

COMBACTE-MAGNET

COMBACTE Collaboration with Clinical Trial Transformation Initiative

Since February of this year COMBACTE CLIN-Net has been working with CTTI on the European part of an observational study to analyze factors that influence patient informed consent in an ICU setting. In the period February – June European hospital sites in the three countries Spain, Belgium and The Netherlands were invited to participate in the Prospective Observational Study of the Risk Factors for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). As the European sites were selected and being prepared to participate in this study, recruitment during the summer at the American site who had started to recruit from the beginning of the year, went so well that the agreed target of 6.850 ICU patients was reached before European sites could be initiated. This resulted in the European sites being put on hold until a follow-on early enrollment intervention study would be initiated following the analysis of the observational study.

To this end a meeting was organized in Washington DC, USA, on 21st October 2016, to review the interim data analysis of the observational study and discuss a possible start of the follow-on early enrollment intervention study. Attendants came from CTTI/Duke University, participating US sites, project FDA, NIH and COMBACTE CLIN-Net. At the meeting, the team decided not to move forward with the early enrollment study at this time. The team however does feel it is important to develop tools that could help to improve enrollment in HABP/VABP clinical trials. These tools could include a validated model for predicting HABP/VABP and example language for early consent. The immediate priority is to complete, clean, and analyze the Risk Factor study data. Then the team will consider amending and reopening the Risk Factor study to create a risk model and/or answer additional questions. COMBACTE-CLIN-Net remains active in the analysis of the Risk Factor study data. If and when European sites are needed for an extension of the observational study or the follow-on early enrollment interventional study, the work invested in pre-selection sites earlier will then pay off.

COMBACTE-NET

Involving Patients and the Public in Antimicrobial Research: are we missing something important?

Involving Patients and the Public in Antimicrobial Research: are we missing something important?
In recent years Interest has rapidly grown in patient and public involvement in research (PPI). Such involvement in health research has been advocated both on ethical grounds and that it improves the quality of research. It is now an international movement with comparable initiatives in  the US, Canada, Australia and the UK. In  Europe we  have the European Patients’ Academy of Therapeutic Innovation (EUPATI) which aims to increase the capacity of patient organisations to be effective advocates and advisors in medicines research. 

What is PPI?
PPI can be defined as working ‘with’ rather than ‘on’ patients and members of the public. This is distinct from either disseminating information about research to the public or people participating as subjects of the research. PPI makes use of the particular expertise of people who have been recipients of health care in activities such as identifying research priorities, acting as members of  project advisory or steering groups and commenting on and developing patient information leaflets. 

How does PPI benefit health research?
There is a growing evidence base documenting the benefits of PPI in health research. Involving patients in activities such as project design and writing information and consent forms can improve  the relevence of research to patients, improve recruitment and retention to clinical trials and increase the chances of the research being put in to practice. 

PPI in antimicrobial research. 
Despite the growing interest in PPI there has apparently been relatively little attention given to PPI in antimicrobial research. There may be a number of reasons for this state of affairs. One is that researchers involved in antimicrobial research may be unaware of the potential benefits of PPI. Another may be the difficulty of building up and sustaining relationships with relevent groups of patients, given the temporary nature of many microbial infections and the lack of specific patient organisations.

As part of COMBACTE-MAGNET Workpackage 6I  our team, based in Bristol in the UK, have set up a patient panel of around 12 people with lived experience of serious infections requiring hospital admissions. Our aim is to provide PPI advice and support to members of the COMBACTE-MAGNET Consortium. Members of our group have been provided with training and support, so that they are in a good position to be involved constructively in the research conducted by COMBACTE-MAGNET. They can provide advice on a range of issues including writing lay summaries of research, developing trial recruitment strategies and advising on what patients may find acceptable in a trial. 

Many researchers are, at first, reluctant  to undertake PPI. However, those who have report that the insights gained can have an invaluable benefit for their work. It is also, from an ethical point of view, the right thing to do!

 

Associate Professor in Patient and Public Involvement based at the University of West England.


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Study Update REJUVENATE

Following study completion of the 10th eligible patient on November 21, REJUVENATE recruitment was temporarily interrupted to prepare for the 10-patient safety review. The Scientific Advisory Committee (SAC) convened on December 14 and made a recommendation for immediate progression of the study, re-opening recruitment and commencing treatment at the higher avibactam dose as per the recent protocol amendment.  In addition, a recommendation was made to include patients with moderate renal impairment in the study at an appropriate adjusted dose.  A second review of safety data will be conducted by the SAC once a further 10 patients have completed all study assessments. The protocol amendment has been approved by German and Spanish authorities and Ethics committees in all three countries. Enrolment into REJUVENATE under the new protocol amendment thus resumes on December 20 in Germany. Enrolment in Spain will commence following approval of an updated informed consent form in Spain. Feedback from the French authorities is expected in early January 2017.

The REJUVENATE study team would like to thank all study sites and National Coordinator teams for their ongoing efforts and outstanding contributions to the study progress in 2016.


COMBACTE-CARE

 

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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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