IMPACTT
Immunoglobulin IgY pseudomonas A clinical trial for cystic fibrosis treatment
| Coordinatore | UPPSALA UNIVERSITET
Organization address
address: SANKT OLOFSGATAN 10 B contact info |
| Nazionalità Coordinatore | Sweden [SE] |
| Totale costo | 7˙055˙166 € |
| EC contributo | 5˙376˙180 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2010-single-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2011 |
| Periodo (anno-mese-giorno) | 2011-01-01 - 2016-12-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
UPPSALA UNIVERSITET
Organization address
address: SANKT OLOFSGATAN 10 B contact info |
SE (UPPSALA) | coordinator | 570˙971.60 |
| 2 |
Immun System I.M.S. AB
Organization address
address: Dag Hammerskjoelds Vaeg 26 contact info |
SE (UPPSALA) | participant | 1˙980˙700.00 |
| 3 |
Nome Ente NON disponibile
Organization address
address: IN DEN DAUEN 6 contact info |
DE (BONN) | participant | 1˙305˙000.00 |
| 4 |
HEINRICH-HEINE-UNIVERSITAET DUESSELDORF
Organization address
address: UNIVERSITAETSSTRASSE 1 contact info |
DE (DUSSELDORF) | participant | 625˙900.00 |
| 5 |
REGION HOVEDSTADEN
Organization address
address: KONGENS VAENGE 2 contact info |
DK (HILLEROD) | participant | 469˙280.00 |
| 6 |
CONSORZIO ITALIANO PER LA RICERCA MEDICA
Organization address
address: Viale Zara - Istituto Villa Marelli 81 contact info |
IT (MILANO) | participant | 122˙800.00 |
| 7 |
CYSTIC FIBROSIS EUROPE EV
Organization address
address: IN DEN DAUEN 6 contact info |
DE (BONN) | participant | 113˙520.36 |
| 8 |
VALSTYBINIS MOKSLINIU TYRIMU INSTITUTAS INOVATYVIOS MEDICINOS CENTRAS
Organization address
address: ZYGIMANTU 9 contact info |
LT (VILNIUS) | participant | 90˙000.00 |
| 9 |
STOCKHOLMS LAENS LANDSTING
Organization address
address: Hantverkargatan 45 contact info |
SE (STOCKHOLM) | participant | 78˙600.00 |
| 10 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
FR (PARIS) | participant | 19˙408.04 |
Mappa
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Obiettivo del progetto (Objective)
'Cystic Fibrosis (CF) is a chronically debilitating and life threatening medical condition. Respiratory insufficiency and complications of chronic lung infection lead to long term reduction in quality of life and health and even to premature death. Chronic bacterial infections with Pseudomonas aeruginosa (PA), Staphylococcus aureus and Haemophilus influezae are typical for CF and repeated courses of antibiotics in heavy doses has more than doubled the median survival age. No preventive or eradicative treatments of PA infection in the lungs exist today. The most significant bacterial pathogen associated with CF pulmonary disease is PA. PA is an opportunistic, life-threatening gram-negative bacteria which produces various immune modulatory products enabling it to survive in the lungs and cause morbidity and mortality. CF patients are particularly at risk of infection due to the viscous mucus lining their airways, which compromises their respiratory function.
The European Medicines Agency granted “Anti-pseudomonas IgY” an Orphan Drug Designation in September 2008, and paediatric CF product development was encouraged. The IMPACTT project will perform a clinical phase III trial, to demonstrate the critical preventive and therapeutic effects of this pioneering intervention therapy for the fatal chronic infection of Pseudomonas aeruginosa in CF patients. The project mobilises the critical mass of experts from academia, patient organisations, clinical trials managers, clinicians and industry aiming to eradicate PA infection in CF patient lungs and thereby alleviate the negative impact of PA on the quality of life of CF patients and their families.
Despite good results with antibiotics, continuous pulmonary deterioration and death of the CF patient is a reality. Alternative therapeutic strategies are badly needed. Our phase I and II clinical studies prove that a single daily gargle with the proposed Anti-Pseudomonas IgY solution significantly improves the condition.'
Introduzione (Teaser)
A European study is exploring the administration of hen antibodies as a novel way of fighting infections in patients with cystic fibrosis (CF). The results have the potential to minimise the emergence of resistant bacteria as a result of prolonged antibiotic use.