Ceftidoren versus levofloxacin in the treatment of patients with Acute Exacerbations of Chronic Bronchitis (AECB). Multi-centre, open-label, randomised, levofloxacin-controlled, parallel groups study, pilot study to evaluate the effects of the treatment on serum inflammatory biomarkers - ND

• Conditions: EXACERBATION OF CHRONIC BRONCHITIS

• Registration Number: EUCTR2011-000531-88-IT
• Lead Sponsor: FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-16
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female outpatients with age between 40 and 75 years with no limitation of race.
2. 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).
3. FEV1 >50% of the predicted value.
4. 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).
5. Negative chest radiography to rule out pneumonia and active tuberculosis.
6. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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-phospste 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 bronchiectasies, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effects of the treatment on serum inflammatory biomarkers;Secondary Objective: to evaluate the clinical efficacy at the Test Of Cure visit (TOC), DAY 6-8 (end of treatment);Primary end point(s): The primary parameter to test the efficacy of the study medications will be the assessment of the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10% will be taken into account. The comparison between treatments will be performed at visit 2 and 3