Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01467297
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2011-09-16
Brief Title:
Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis AECB
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-000531-88 | EUDRACT_NUMBER | None | None |