Status:
COMPLETED
Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)
Lead Sponsor:
University of Milan
Conditions:
COPD Exacerbation
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be compared, ceftidoren ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01467297
Start Date
January 1 2012
End Date
June 1 2012
Last Update
June 5 2012
Active Locations (1)
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1
IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Milan, Italy, 20122