Project Summary

IMPACTT – A European study aiming at prophylaxis of PSEUDOMONAS aeruginosa infections in CF patients

Pseudomonas aeruginosa is the most significant bacterial pathogen associated with CF pulmonary disease. Today a pseudomonas infection is treated by repeated courses of antibiotics which has a negative effect on life quality. The IMPACTT project explores a new method to prevent lung infection by pseudomonas bacteria as long as possible.

The IMPACTT clinical phase III trial 2013

Aim of the study is to provide a therapy for prophylaxis of P. aeruginosa (PA) infections in CF patients. The clinical trial study will complete a prospective randomized, placebo-controlled, double blind, multicenter study to evaluate clinical efficacy and safety of the IgY anti-Pseudomonas antibodies in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients. The European Research project started on January 1st 2011 as a collaborative effort between ten partners from around Europe. Currently patients in 30 centers from 4 countries, Germany, Belgium, Sweden, and Italy, are participating in the study. Ireland has joined the clinical Study in 2013, and we hope the IMPACTT project will be able to welcome more countries in the near future.

This study is still recruiting patients. For more information, please contact Dr. Jutta Bend, jbend@muko.info.

Why is it so important to fight and prevent Pseudomonas infection?

Although important progress has been made in the medical treatment and care of CF, and life expectancy has increased considerably, Cystic Fibrosis still is a chronic, debilitating medical condition. Airway infections are one of the main reasons of deterioration in CF.

Due to the underlying genetic defect in CF, sticky mucus clogs the lungs. This leads to colonization of the lungs with bacteria, chronic inflammation and lung infections. Pseudomonas aeruginosa (PA) is the most significant bacterial pathogen associated with CF pulmonary disease. CF patients are particularly at risk of pseudomonas infection due to the viscous mucus lining their airways.

IgY - a new remedy to prevent Pseudomonas infection... made from eggs

Today a pseudomonas infection is treated by repeated courses of antibiotics, either inhaled, as pills or intravenously, which has a negative effect on life quality. The IMPACTT project aims at exploring a new way to prevent lung infection by pseudomonas bacteria.

Research of the past years developed an antibody against Pseudomonas bacteria, called IgY, which is produced from egg yolk. This anti-Pseudomonas IgY is prepared by vaccinating hens with Pseudomonas aeruginosa bacteria. The vaccinated hens produce antibodies against PA that are transferred to the egg yolk in high concentration. Anti-Pseudomonas IgY is then extracted from the egg yolk and put into a liquid medical product. This product only contains a water extract from egg yolk without any other additives.

Patients are asked to gargle this liquid product every night. This is expected to form a barrier in their throat and thus prevent that pseudomonas descends from the patient’s nose and throat into the lungs. Past studies with small numbers of patients indicated that IgY may have a potential to form such a “barrier” and showed that the risk for adverse events was rather low.

The European Medicines Agency granted "Anti-pseudomonas IgY" an Orphan Drug Designation.

  1. Hens are immunized with P. aeruginosa (PA)
  2. The hen produces IgY against PA that are transferred to the egg yolk.
  3. The antibodies are separated from the egg yolk …
  4. … in order to be gargled by the CF-patient

The IMPACTT Project

Researchers, patient organizations, clinicians and industry joined forces in 2011 to test a medical formula to prevent PA infections in CF patient lungs. Another important objective is to explore ways of meaningfully involving patients and family members into clinical CF research. By participating in this study you can contribute to finding new ways to prevent pseudomonas infections, which will hopefully lead to better health outcomes and life expectancy for people with CF all around the world.

IMPACTT is supported by the European Union 7th Framework Programme.