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

Exclusion Criteria

• •1. Hypersensitivity or allergy to antibacterial betalactams or fluoroquinolones and/or to any component of the study medications.
• •2. Underlying asthma.
• •3. 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.
• •4. Childbearing potential where pregnancy is not excluded by pregnancy test in urine (HCG), or lactation.
• •5. History of tendinopathy.
• •6. Recent or past history of psychiatric illness or epilepsy.
• •7. Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities.
• •8. Latent or known deficiencies for the glucose-6-phosphate dehydrogenase activity.
• •9. 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.
• •10. Other lower respiratory tract illness: severe bronchiectasis, cystic fibrosis, or pulmonary malignancy.
• •11. Concurrent infections and /or neoplasm.
• •12. Concomitant treatment with hypoglycemic drugs.
• •13. 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);
• •14. Treatment with antibiotics or antibacterials within the previous week
• •15. Treatment with experimental drugs in the previous 4 weeks