Abstract
BackgroundAntibiotic-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/DesignA 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.DiscussionABACOPD 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 numberClinicalTrials.gov: NCT01892488.
Highlights
Antibiotic-resistant strains of pathogenic bacteria are increasingly prevalent in hospitals and the community
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
Key inclusion criteria Patients will be enrolled into the study when diagnosed with moderate acute exacerbation of COPD according to the definition of the Global initiative for chronic Obstructive Lung Disease (GOLD) without respiratory failure or need for intermediate or intensive care if they fulfill the following criteria: respiratory tract infection with a clear indication for antibiotic treatment) – Smoking history of 10 Pack Years or more
Summary
The novel aspect of the proposed trial is to investigate non-inferiority of placebo against adequate antibiotic treatment in addition to well-defined standardized treatment of moderate AE-COPD in order to show that antibiotics are not needed for this indication. The trial is designed and powered to prove that antibiotic therapy is not necessary in addition to standard of care in patients with moderate AE-COPD with the aim to reduce unnecessary antibiotic prescriptions and the ultimate goal to reduce antibiotic resistance This is the first study in the field to use a non-inferiority trial design including a placebo arm. The impact of potential missing values could be anti-conservative in the per-protocol analysis when demonstrating non-inferiority to placebo as well (pts with no improvement to placebo drop) and the ITT population is used here with a strategy that should maximize differences between treatment groups in case of uncertainty about outcome, because irrelevance of differences between treatment strategies is the objective to be demonstrated In this complex situation missing values will be counted as failure in the placebo-group and as a success for patients in the antibiotics group. All were involved in drafting the manuscript or revising it critically for important intellectual content and have given final approval of the version to be published
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