COPD Exacerbation Clinical Trial
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
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.
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