The IMPACTT Project is a JOINT EFFORT between NINE COUNTRIES.
started on January 1st 2011 as collaboration between ten partners from seven European countries: Sweden, Germany, Denmark, Belgium, France, Italy and Lithuania. The IMPACTT project is divided into eight workpackages, each workpackage plays a dedicated role in either the project's pre-clincal or clinical research (the core of the IMPACTT project). The aim of the clinical trial Clinical trial III (ClinicalTrials.gov Identifier:NCT01455675) is the assessment of recurrence of PA in the sputum of the patients who gargle with an Anti-Pseudomonas IgY formulae for two years. Anti-PsA formulae is the Drug candidate under investigation in all WPs. The clinical trial (CT) has currently 107 patients from 9 European countries: Germany, Sweden, Italy, Belgium, Ireland, Poland, Hungary, Spain, and Austria. The five newest countries were added with an Amendment to the EC GA in 2013. The project was prolonged with an amendment II to the EC Grant Agreement on 2014-12-09, by two years.
A primary goal is to provide technical data for an Orphan Drug registration (for marketing authorization) to make the Anti-Pseudomonas treatment available for all CF patients within EU. IMPACTT is supported by the European Union Seventh Framework Programme. The purpose of the clinical study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection. ClinicalTrials.gov Identifier:NCT01455675. To provide an intervention therapy for prophylaxis and treatment of P. aeruginosa (PA) infections in CF patients. PLEASE see our study site list. For more information, please contact Dr. Jutta Bend, via Email firstname.lastname@example.org or phone: +49 228 98780-47. countries.
The IMPACTT Project - a joint collaboration between several European countiries. It started on January 1st 2011 is an European FP7 project (Grant agreement no: 261095) collaboration between ten partners from seven European countries: Sweden, Germany, Denmark, Belgium, France, Italy and Lithuania. The project has since expanded to include other countires thanks to a Swedish National Grant and the ECRIN I-A grant in 2013 and 2014! The project mobilizes the critical mass of experts from academia, patient organizations, clinical trials managers, clinicians and industry aiming to prevent PA infections in CF patient lungs and thereby alleviate their negative impact on the quality of life of CF patients and their families. CF Europe has an important project objective, which is to explore ways of meaningfully involving patients and family members into clinical CF research.
The IMPACTT clinical phase III trial
The IMPACTT project will complete a clinical phase III trial to demonstrate the critical preventive and therapeutic effects of a pioneering intervention therapy for the fatal chronic infection of Pseudomonas aeruginosa in CF patients. The therapy is based on the avian polyclonal Anti-Pseudomonas IgY formulation.
The recruitment was closed June 2015.The clinical study has been registered in the international clinical trial registry clinicaltrials.gov.
The IMPACTT Project ''workpackages'':
The IMPACTT project is divided into eight work packages - which are specific areas of ''work'' in the project. Eack workpackage plays a dedicated role in either the project's preclincal or clinical research. Please see to powerpoint on the workpackage breakdown, by clicking here; or go to ''Project Workpackages'' on the menu.