Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD

PHASE4CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

June 7, 2013

Primary Completion Date

April 23, 2019

Study Completion Date

June 5, 2019

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Sultamicillin

"Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated.~Experimental intervention:~Antibiotic therapy with aminopenicillin + betalactamase inhibitor (oral Sultamicillin (2 x 750mg)) for 5 days as supplement to standard of care for patients with AE-COPD."

DRUG

Placebo

"Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated.~Control intervention:~Placebo for 5 days as supplement to standard of care for patients with AE-COPD"

Trial Locations (32)

Unknown

Universitätsklinikum Aachen, Aachen

Krankenhaus Bad Arolsen, Bad Arolsen

Lungenklinik Ballenstedt, Ballenstedt

Charité - Universitätsmedizin Berlin, Berlin

HELIOS Klinikum Emil von Behring Berlin, Berlin

Pneumologische Praxis am Schloss Charlottenburg Berlin, Berlin

Vivantes Klinikum Neukölln, Berlin

Vivantes Klinikum Spandau, Berlin

Klinikum der Ruhr-Universität Bochum, Bochum

Pneumologische Gemeinschaftspraxis Bonn, Bonn

Forschungszentrum Borstel, Borstel

Klinikum Dortmund gGmbH, Dortmund

Universitätsklinikum Dresden, Dresden

Pneumologische Klinik Waldhof Elgershausen, Elgershausen

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen

Praxis Dr. med. Ina Itzigehl Euskirchen, Euskirchen

Universitätsklinikum Freiburg, Freiburg im Breisgau

Universitätsmedizin Greifswald, Greifswald

HELIOS Klinik Hagen-Ambrock, Hagen

Elbpneumologie Hamburg, Hamburg

Schwerpunktpraxis Colonnaden Hamburg, Hamburg

Medizinische Hochschule Hannover, Hanover

Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg

Universitätsklinikum Heidelberg, Heidelberg

Lungenfachklinik Immenhausen, Immenhausen

Universitätsklinikum Jena, Jena

Universitätsklinikum Schleswig-Holstein Kiel, Kiel

Universitätsklinikum Schleswig-Holstein Campus Lübeck, Lübeck

Brüderkrankenhaus St. Josef Paderborn, Paderborn

Diakoniekrankenhaus Rotenburg, Rotenburg (Wümme)

Krankenhaus Bethanien Solingen, Solingen

HELIOS Klinikum Wuppertal-Barmen, Wuppertal

All Listed Sponsors
collaborator

CAPNETZ Stiftung

OTHER

lead

Hannover Medical School

OTHER

NCT01892488 - Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD | Biotech Hunter | Biotech Hunter