Inhaled ColiFin® in adult bronchiectasis patients with new asymptomatic Pseudomonas aeruginosa infection – an open-label, proof of concept - randomized controlled trial (DZL-Eradicate)
interventional
N/A
1 country
13
To evaluate the effect of ColiFin® therapy compared to SOC sputum/airway culture negativity for PA 28 weeks after randomization.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2024
Actual (reported)Proportion of sputum/airway culture negativity (=3 consecutively negative sputum/airway cultures) for PA 28 weeks after randomisation
Change in PA (semi-quantitative) in sputum from baseline to Day 29 of treatment
Rate of pulmonary exacerbations in 28 weeks after randomisation
Rate of severe exacerbations (hospitalizations) in 28 weeks after randomisation
Time to first pulmonary exacerbation after start of treatment
Change from baseline in respiratory symptom domain of the SGRQ ountil 28 weeks after randomization
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
Waldburg-Zeil Akutkliniken GmbH & Co. KG
Wangen Im Allgaeu, 88239, Germany
Universitaetsklinikum Schleswig-Holstein AöR
Luebeck, 23538, Germany
Dr. Constanze C. Maresch
First Submitted
September 2, 2024
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Augustinerinnen Krankenhaeuser gGmbH
Cologne, 50678, Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen, 45239, Germany
SLK-Kliniken Heilbronn GmbH
Loewenstein, 74245, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Duesseldorf AöR
Duesseldorf, 40225, Germany
HELIOS Klinikum Emil von Behring GmbH
Berlin, 14165, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 13353, Germany
Goethe University Frankfurt
Frankfurt Am Main, 60590, Germany
Ludwig Maximilian University Of Munich
Munich, 80336, Germany
Philipps-Universitaet Marburg
Marburg, 35043, Germany