Published in:
Open Access 01-12-2015 | Study protocol
Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD – The ABACOPD Study
Published in: BMC Pulmonary Medicine | Issue 1/2015
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Background
Antibiotic-resistant strains of pathogenic bacteria are increasingly prevalent in hospitals and the community. Acute exacerbations of COPD (AE-COPD) often result in administration of antibiotics although more than half of exacerbations are associated with detection of respiratory viruses and potentially pathogenic bacteria can only be detected in 20-30% of cases. There is a paucity of placebo-controlled clinical trials and up to today no single study has been powered sufficiently to prove the efficacy of antibiotic treatment in AE-COPD. Most studies so far did not include current standards of care comprising administration of systemic corticosteroids.
Methods/Design
A total of 980 patients with moderate acute exacerbations will be included in 22 German centers (hospitals and private practices). Patients will receive a standardized treatment for exacerbation including systemic corticosteroids, inhaled bronchodilators and supplementary oxygen if needed and will be randomized to additional treatment with placebo or antibiotic (oral sultamicillin) for five days.
The primary endpoint is clinical failure defined by need for additional antibiotic treatment until day 30. Secondary endpoints will assure that management of AE-COPD without antibiotics does not result either in increased occurrence of relapse, new exacerbations, prolonged recovery, or unwanted long-term consequences.
Discussion
ABACOPD will be the first sufficiently powered double-blind placebo-controlled study in the field to systematically assess the question whether antibiotics, known to increase antibiotic resistance, are really needed in a well-defined patient cohort receiving state-of-the art treatment in all other aspects.
Trial registration number
ClinicalTrials.gov: NCT01892488.