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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Blasi, University of Milan
ClinicalTrials.gov Identifier:
NCT01467297
First received: September 16, 2011
Last updated: June 2, 2012
Last verified: June 2012
  Purpose

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 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days. Primary objective of the study is to evaluate the effects of the treatment on serum inflammatory biomarkers and the secondary objective is to evaluate the clinical and microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).

The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4); Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy assessment, Day 28-30).

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.


Condition Intervention Phase
COPD Exacerbation
Drug: ceftidoren
Drug: levofloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB). Multi-centre, Open-label, Randomised, Pilot Study to Evaluate the Effects of the Treatment on Serum Inflammatory Biomarkers

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • serum inflammatory biomarkers [ Time Frame: change from baseline at day 2-4 and day 7-10 ] [ Designated as safety issue: No ]
    assessment of the speed of reduction of inflammatory parameters (C-reactive protein(CRP), procalcitonin( PCT) and mucin-like glycoprotein(KL6)). Every reduction of 10% will be taken into account.


Secondary Outcome Measures:
  • clinical efficacy [ Time Frame: change from baseline to day 2-4 and day 7-10 ] [ Designated as safety issue: No ]
    Clinical assessment (Vist 2 and visit 3) of signs and symptoms of acute exacerbations of Chronic bronchitis(AECB), such as sputum purulence, sputum volume, dyspnoea, cough and body temperature using a clinical score.The total scores obtained at Visit 2 and Visit 3 test of cure (TOC) will be compared with those obtained at Visit 1.

  • Microbiology efficacy [ Time Frame: change from baseline to day 2-4 and day 7-10 ] [ Designated as safety issue: No ]

    Microbiological assessments will be performed on valid sputum specimens At the TOC Visit, 7-10 days after the end of treatment.

    The results obtained at Visit 2 and Visit 3 test of cure(TOC) will be compared with those obtained at Visit 1



Enrollment: 40
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ceftidoren
ceftidoren 200 mg bid for 5 days
Drug: ceftidoren
ceftidoren 200 mg bid for 5 days
Other Names:
  • Giasion
  • J01D
Active Comparator: levofloxacin
levofloxacin 500 mg once daily for 7 days
Drug: levofloxacin
levofloxacin 500 mg once daily for 7 days
Other Names:
  • levoxacin
  • J01M

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467297

Locations
Italy
IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Milan, Italy, 20122
Sponsors and Collaborators
University of Milan
Investigators
Study Chair: Francesco B Blasi, MD University of Milan Italy
  More Information

No publications provided

Responsible Party: Francesco Blasi, professor of respiratory medicine, University of Milan
ClinicalTrials.gov Identifier: NCT01467297     History of Changes
Other Study ID Numbers: SP1, 2011-000531-88
Study First Received: September 16, 2011
Last Updated: June 2, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Milan:
Chronic bronchitis
exacerbations
treatment
ceftidoren
levofloxacin
inflammation

Additional relevant MeSH terms:
Bronchitis, Chronic
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014