The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa
after successfully treated acute or intermittent infection.
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Locations near you
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Full eligibility criteria for NCT01455675
Ages eligible for Study
5 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
CF patients diagnosed according to specific clinical features and either a positive sweat chloride in double proofs or presence of disease-associated CFTR mutations in both alleles
Males and females 5 years of age and above (being able to gargle)
CF patients having a FEV1 value between 50% and 130% of predicted value (according to Knudson formula)
CF patients who have had one to several sputum or throat cough swabs or endolaryngeal suction cultures positive for PA within the last three years and for whom PA has been successfully eradicated.
Sputum / throat cough swab/ endolaryngeal suction culture negative for PA and other gram-negative bacteria on study entry.
Patients and/ or their legal representative who are willing and able to give informed consent/ assent to participate in the study after thorough information
Subjects of child bearing potential and who are sexually active must meet the contraception requirements (i.e. oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms).
Microbiologic or serologic evidence of chronic infection with PA. Definition of chronic PA infection: Three cultures (sputum or throat cough swabs or endolaryngeal suction) have been positive for PA for 6 consecutive months (at least 3 cultures have to be taken) or more, .
Patients, who have positive sputum culture or throat cough swab or endolaryngeal suction culture for gram-negative bacteria, such as PA, S. maltophilia, B. cepacia, A. xylosoxidans (eradication before entry in study is possible), Patients, who have positive sputum culture or throat cough swab or endolaryngeal suction culture for atypical Mycobacteria and / or Aspergillus fumigates, associated with clinical symptoms that may necessitate specific treatment.
History of allergy/hypersensitivity to hens' egg proteins (including medication allergy) that is deemed relevant to the trial by the investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication.
Patient with a known relevant substance abuse, including alcohol or drug abuse.
Start of a new concomitant or chronic medication for CF within 4 weeks before inclusion.
Clinically relevant diseases or medical conditions other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This includes, but is not limited to, significant hematological, hepatic, renal, cardiovascular, and neurological diseases
(diabetic patients may participate if their disease is under good control prior to inclusion).
Participation in another study with an investigational drug within one month or 6 half-lives (whichever is greater) preceding the inclusion.
The patient is an employee of the investigator or the institution with direct involvement in the trial or other trials under the direction of the investigator or their members.
Patients who are pregnant cannot be included into the study. This will be tested at inclusion visit with a urine pregnancy test (in female patients older than 10 years with secondary sexual characteristics)
All locations for NCT01455675
Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum
Innsbruck, Austria, 6020
Salzburg, Austria, 5020
Clinic of Pediatric Respiratory Diseases, Infectious Diseases and Travel Clinic
Brussels, Belgium, 1090
University Hospital Leuven, Kindergeneeskunde
Leuven, Belgium, 3000
Charité, Christiane Herzog Zentrum
Berlin, Germany, 13353
Klinikum der Ruhr Universität Bochum
Bochum, Germany, 44791
Dresden, Germany, 01307
Düsseldorf, Germany, 40225
Essen, Germany, 45122
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
Freiburg, Germany, 79106
Universitätsklinikum Gießen und Marburg GmbH
Gießen, Germany, 35392
MH Hannover (adults)
Hannover, Germany, 30625
MH Hannover (children)
Hannover, Germany, 30625
Universitätsklinik Jena, Mukoviszidosezentrum
Jena, Germany, 07740
Städtisches Krankenhaus Kiel GmbH
Kiel, Germany, 24116
University Hospital of Cologne
Köln, Germany, 50924
Mainz, Germany, 55131
Tübingen, Germany, 72076
Würzburg, Germany, 97080
Heim Pal Hospital for Children
Budapest, Hungary, 1089
Országos Korányi TBC és Pulm. Intézet, XIX. J fsz. Kronikus-CF care
Budapest, Hungary, 1121
Cork University Hospital
Our Lady´s Children´s Hospital
Dublin, Ireland, 12
Dublin, Ireland, 24
Mid-Western Regional Hospital
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
Firenze, Italy, 50139
Istituto Ospedale Giannina Gaslini
Genova, Italy, 16100
Centro Regionale Fibrosi Cisica Lazio
Roma, Italy, 00161
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy, 37126
Szpital Dzieciecy Polanki im. Macieja Plazynskiego w Gdansku sp Z o.o. Poradnia Leczenia
Gdansk, Poland, 80-308
Centrum Medyczne Karpacz Spólka Akcyjna
Karpacz, Poland, 58-540
NZOZ Sanatorium Cassia Villa Medica
Rabka - Zdrój, Poland, 34-700
Instytut Matki i Dziecka Zaklad Mukowiscydozy
Warsaw, Poland, 01-211
Wojewódzki Szpital Specjalistyczny im. M.Kopernika Ośrodek Pediatryczny im. dr J.Korczaka
Karolinska University Hospital, Huddinge - CF-Centre
Stockholm, Sweden, 141 86
Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center
Uppsala, Sweden, 75185
View full eligibility
Tris trial is registered with FDA with number: NCT01455675. The sponsor of the trial is Mukoviszidose Institut gGmbH and it is looking for 164 volunteers for the current phase.
Official trial title: Phase III Study to Evaluate Clinical Efficacy and Safety of Avian Polyclonal Anti-Pseudomonas Antibodies (IgY) in Prevention of Recurrence of Pseudomonas Aeruginosa Infection in Cystic Fibrosis Patients
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