Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
Brief 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).


Options:
A: Inclusion Criteria:

* Male or female out-patients \>/= 45 years
* Subjects suffering from chronic bronchitis
* FEV1\</= 70% and FEV1/FVC \</= 70% predicted from age, height and sex
* No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening
* Sputum production on most days, even when exacerbation free
* Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening
* Smoking history of at least 20 pack-years
* Subjects willing and able to give fully informed written consent

Exclusion Criteria:

* Subjects with contra-indications to moxifloxacin- Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis- Subjects who are actively participating in intensive pulmonary rehabilitation programs
* Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA
* No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage
* Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)
B: Inclusion Criteria:

* Acute exacerbation of COPD type I or II according to GOLD
* Ability to perform lung function tests
* Ability to take oral medication

Exclusion Criteria:

* Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
* Pretreatment ( \> 24 hours) with an antibiotic for the present exacerbation.
* Pretreatment with corticosteroids (\>30 mg for more than 4 days) for the present exacerbation.
* Progression or new radiographic abnormalities on the chest X-ray.
* Severe exacerbation that required mechanical ventilation.
* History of bronchiectasis
* Recent or unresolved lung malignancy.
* Other disease likely to require antibiotic therapy.
* Significant gastrointestinal or other conditions that may affect study drug absorption.
* Class III or IV congestive heart failure or stroke.
* Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (\>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
* Cystic fibrosis
* Tuberculosis.
* Impaired renal function (creatinine clearance \< 20 ml/min).
C: 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 \<50 mm Hg despite O2 administration and / or respiratory acidosis (pH \<7.35 and PaCO2\> 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 \< 1000/µ)l; systemic corticosteroids (≥20 mg prednisolon equivalent/day \> 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.
D: Inclusion Criteria:

* Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of
* patients older than 40 years old,
* smokers or ex-smokers of more than 10 pack-years,
* with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC\<0.7%.

Exclusion Criteria:

* Severe COPD (FEV1\<50%)
* Pneumonia
* Active neoplasm
* Tracheotomy
* Criteria for hospitalisation
* Patients previously being on antibiotics
* Immunodepressed patients
* History of hypersensitivity to beta-lactams or intolerance to clavulanate
* Enrollment in other clinical trials
* Patients who refuse to take part in this study
* Patients who have not had a spirometry test for the past two years

Answer: C