study to demonstrate that antibiotics are not needed in moderate acute exacerbations of copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. the primary objective of abacopd is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the "failure-rate" for patients with acute moderate exacerbations of copd (ae-copd) treated with placebo instead of antibiotic treatment both on top of standard of care. a patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (toc at day 30, primary endpoint).


Eligibility criteria:
inclusion criteria: * adults, either sex, older or equal than 40 years of age * for female patients, the following conditions are to be met: * has been postmenopausal for at least 1 year, or * is surgically incapable of bearing children, or * is of childbearing potential, and the following conditions are met: * has a negative pregnancy test (urine- or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following criteria * must agree to abstinence or use an accepted method of contraception. the subject must agree to continue with the same method throughout the study. * having only female sexual partners * sexual relationship with sterile male partners only * patients diagnosed with copd stages i-iv as defined by the global initiative for chronic obstructive lung disease (gold). and * doctor's diagnosis of acute (onset \< 7 days) moderate exacerbation of copd defined by a sustained worsening of the patient's condition (including at least 2 of the following symptoms: increased dyspnea, increased sputum production, sputum purulence and increased cough), from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in patient with underlying copd, needing additional medical assistance. * absence of community acquired pneumonia or lower respiratory tract infection with a clear indication for antibiotic treatment as determined by procalcitonin level \< 0.25 ng/ml and/or absence of pulmonary infiltrates on routine chest x-ray. * smoking history of at least 10 pack years or more. * patients must be able to complete diaries and quality of life questionnaires. * patients must sign and date an informed consent prior to any study procedures. exclusion criteria: * severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (pao2 \ 45mmhg)) or mental confusion or circulatory insufficiency (need of vasopressors) * fever (\>38.5°c) * known impaired hepatic or renal function * active or suspected tuberculosis infection of the respiratory tract * acute exacerbation of asthma * suspected or known hypersensitivity to, or suspected serious adverse reaction to sultamicillin; suspected or known hypersensitivity to penicillins or cephalosporins * immunosuppression or immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils \ 14 days; hiv-infection; immunosuppression after organ- or bone marrow transplant)- patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia * oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed) * in-patient treatment within the last 30 days * an antibiotic is clearly indicated for treatment of a known infection * known mrsa (methicillin-resistant staphylococcus aureus) colonization or infection * patients with known bronchiectasis * patients with known bacterial airway colonization (\>3 positive sputum cultures in the previous year) * progressively fatal disease, or life expectancy ≤6 months * mononucleosis * lymphatic leukemia * severe gastro-intestinal disorders with vomiting and diarrhea * women who are breast feeding * patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase. * patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study. * patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow up visits, and unlikelihood of completing the study.

Keywords: copd ae-copd chronic obstructive pulmonary disease acute exacerbations of chronic obstructive pulmonary disease