Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)

Inclusion criteria

• Male or female outpatients with age between 40 and 75 years with no limitation of race.
• Patients with a diagnosis of Acute Exacerbations of Chronic Bronchitis* characterized by the presence of the following three symptoms, or at least two including purulence:

• increased dyspnoea;
• increased of sputum volume;
• increased of sputum purulence, that had to be confirmed macroscopically by the investigator.

• Chronic bronchitis is characterized by cough and excessive secretion of mucus and is diagnosed when patients report production of sputum on most days over at least three consecutive months for 2 or more consecutive years (American Thoracic Society 1995).
• FEV1 >50% of the predicted value.
• Availability of a valid sputum specimen of broncho-pulmonary origin for microbiological evaluation obtained by either expectoration, suction, bronchoscopy or bronchial lavage. Valid samples will be characterized by < 10 squamous epithelial cells and > 25 polymorph nuclear leucocytes per low-power magnification 100x field (Wilson 2004).
• Negative chest radiography to rule out pneumonia and active tuberculosis.
• Written informed consent to the trial signed and dated by the patient according to the local regulations, obtained prior to all activities related to the trial.

Exclusion criteria

• Hypersensitivity or allergy to antibacterial betalactams or fluoroquinolones and/or to any component of the study medications.
• Underlying asthma.
• Systemic corticosteroids (treatment since ≤ 2 weeks before trial drug administration) are excluded, unless patients are chronically treated (treatment for >2 weeks before trial drug administration). Corticosteroid nasal spray administration is allowed in the first 3 days of the study drug administrations only.
• Childbearing potential where pregnancy is not excluded by pregnancy test in urine (HCG), or lactation.
• History of tendinopathy.
• Recent or past history of psychiatric illness or epilepsy.
• Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities.
• Latent or known deficiencies for the glucose-6-phosphate dehydrogenase activity.
• Known severe hepatic and/or renal insufficiency (AST, ALT and/or creatinine levels more than twice as high as the Upper Laboratory Norm, ULN). Should laboratory data not be available when treatment is required, the patient may be conditionally enrolled.
• Other lower respiratory tract illness: severe bronchiectasis, cystic fibrosis, or pulmonary malignancy.
• Concurrent infections and /or neoplasm.
• Concomitant treatment with hypoglycemic drugs.
• Patients under treatment with fenbufen and xanthines. Patients treated with xanthines could however be recruited if plasma levels were monitored; if plasma levels exceeded concentrations of 10-15 micrograms/ml, the daily dosages of xanthines should be lowered by the Investigator (Hendels 1983);
• Treatment with antibiotics or antibacterials within the previous week
• Treatment with experimental drugs in the previous 4 weeks