> Recent studies > ERADICATE study
ERADICATE study
EudraCT-Nr.: 2021-002335-33
Clinical picture
Pseudomonas aeruginosa infection in patients with bronchiectasis
Objective
The study investigates the effect of a four-week course of inhaled colistin treatment in patients with bronchiectasis, compared with a control group (no colistin), on the colonisation of sputum and airway cultures by Pseudomonas aeruginosa (PA) 28 weeks after randomisation.
Admission criteria
Inclusion criteria
Age ≥ 18 years at the time of screening
Bronchiectasis, confirmed by a chest CT scan
new positive sputum culture for PA (no more than 12 weeks old at the time of screening)
no recent onset of new respiratory symptoms or worsening of existing respiratory symptoms (e.g. cough, sputum volume, sputum colour, sputum viscosity, haemoptysis, reduced physical capacity, malaise, fatigue, etc.) in the 2 months prior to a new positive PA sputum culture, as assessed by the investigator
informed written consent
Negative serum/urine pregnancy test in women of childbearing age
Women of childbearing age must agree to use a highly effective method of contraception during the study treatment and for at least 4 weeks afterwards. Further information.
Male participants must use a condom during treatment and until the end of the relevant systemic exposure period, as well as for a further period of 90 days, and the non-pregnant female partner must also use an additional method of contraception.
Exclusion criteria
Bronchiectasis caused by cystic fibrosis (CF)
Known previous infection with PA within the last 5 years prior to the new positive PA culture*
Treatment with antibiotics effective against Pseudomonas in the period between the new PA-positive sputum culture and the baseline consultation
Planned treatment with antibiotics effective against Pseudomonas during participation in the study.
Any treatment with inhaled antibiotics or long-term treatment effective against Pseudomonas (≥3 months) in the 5 years prior to screening.
A history of known hypersensitivity to the test product.
Hypersensitivity or known intolerance to colistimethate sodium, colistin, polymyxin B or other polymyxins.
Known diagnosis of myasthenia gravis or porphyria
ppFEV1 < 30% (after bronchodilation)
Pregnant women
Breastfeeding women
Severely impaired renal function (GFR ≤ 30 ml/min)
Participation in another clinical trial
*Patients with a positive culture for PA from respiratory specimens within the last 5 years, but within a period of ≥3 years prior to the re-detection of PA, who had at least 2 negative cultures for PA from respiratory specimens per year during those 3 years whilst not receiving treatment active against Pseudomonas, are also considered PA-negative and may be included in the study. Respiratory specimens include throat swabs, sputum, tracheal/bronchial secretions and bronchial lavage fluid.
Duration of participation
7 months (1 month of treatment, 24 weeks of follow-up)
Examinations and/or treatments as part of the study.
Treatment with inhaled colistin over 28 days.
UnTests, including:
- Sputum tests
- Questionnaires
- Laboratory tests (blood and urine)
- Lung function tests
Funding
The study was funded by the German Centre for Lung Research (DZL) and received financial support from a pharmaceutical manufacturer.
Participating examination centres
Berlin | Charité – Universitätsmedizin Berlin CVK
Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine
Dr. Till Othmer, PD Dr. med. Stephanie Thee
Contact:
Frau Rola Khalife
E-Mail: rola.khalife@charite.de
Tel.: +49 (0)30 450 616 426
Essen | Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Abteilung Pneumologie-Allergologie
Dr. Sivagurunathan Sutharsan, Dr. Matthias Welsner
Contact:
Frau Thea-Lisa Schwarzer
E-Mail: thea-lisa.schwarze@rlk.uk-essen.de
Tel.: 0201-433-4698
&
Frau Jessica Zmudzinski
E-Mail: Jessica.Zmudzinski@rlk.uk-essen.de
Tel.: 0201-433-4893
Frankfurt a. M. | Universitätsklinikum Frankfurt
Medizinische Klinik 1, Schwerpunkt Pneumologie und Allergologie
Dr. Wolfgang Gleiber, Dr. Julius Kohlhäufl
Contact:
Studienambulanz Pneumologie
Tel.: 069 6301 84301
E-Mail: pneumo.studien@kgu.de
Gießen/ Marburg | Universitätsklinikum Gießen u. Marburg GmbH
Standort Marburg
Klinik für Pneumologie, Schlaf- und Intensivmedizin Sektion Atemwegsinfektionen
Prof. Dr. Claus Vogelmeier, Prof. Dr. Bernd Schmeck
Contact:
Frau Ute Wissner
E-Mail: ute.wissner@uni-marburg.de
Tel.: 06421-58-69062
Hannover | Medizinische Hochschule Hannover
Klinik für Pneumologie und Infektiologie
Carl-Neuberg-Straße 1, 30625 Hannover
Prof Dr. Felix Ringshausen
Contact:
Frau Annika Bock
E-Mail: Bock.annika@mh-hannover.de
Tel.: 0511 532 3661
Berlin | HELIOS Klinikum Emil von Behring GmbH
Lungenklinik Heckesborn, Walterhöfestr. 11, 14165 Berlin
Dr. med. David Krieger, Prof. Dr. med. Torsten Gerriet Blum
Contact:
Jessica Gallisch
E-Mail: Jessica.Gallisch@helios-gesundheit.de
Tel.: 030 8102 6132
Köln | Krankenhaus der Augustinerinnen “Severinsklösterchen”
Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin
PD Dr. med. Urte Sommerwerck, Dr. med. Agnieszka Ryba, Dr. Tobias Winermantel
Contact:
Linda Kunz
E-Mail: LKunz@severinskloesterchen.de
Tel.: +49 221 3308-5421
Lübeck | Universitätsklinikum Schleswig-Holstein – Campus Lübeck
Medizinische Klinik III – Pulmologie, Ratzeburger Allee 160, 23528 Lübeck
PD Dr. Daniel Drömann, Dr. Patrick Parschke
Contact:
Tel.: 0451 500 45002
E-Mail: studienzentrum.pneumologie-infektiologie@uksh.de
München | LMU Klinikum Medizinische Klinik und Poliklinik V,
Campus Innenstadt, Ziemsstr. 1, 80336 Münschen
Dr. Pontus Mertsch, Dr. Susanne Nährig
Contact:
E-Mail: Pontus.Mertsch@med.uni-muenchen.de
Tel.: 089 440052209
Stuttgart | Robert Bosch Krankenhaus – Lungenzentrum Stuttgart
Abteilung Pneumologie und Beatmungsmedizin
Dr. med. Joana Paderewska
Contact:
Nina Lutz
E-Mail: nina.lutz@rbk.de
Tel.: +49 711 8101-7628
Klinik für Pneumologie
Wangen | Waldburg-Zeil Kliniken, Fachkliniken Wangen
Klinik für Pneumologie
Dr. med. Philipp Meyn. Dr. med. Dominik Harzheim
Contact:
Susanne Hirschmann
E-Mail: Susanne.Hirschmann@wz-kliniken.de
Tel.: +49 (0) 7522 797-1037