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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00717561 |
Purpose
The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia |
| Estimated Enrollment: | 230 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1: Experimental
n/a
|
Drug: Avelox (Moxifloxacin, BAY12-8039)
IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours
|
|
Arm 2: Active Comparator
n/a
|
Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin
IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes. Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least 2 of the following conditions:
Exclusion Criteria:
Contacts and Locations| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
| Italy | |
| Not yet recruiting | |
| Milano, Italy, 20157 | |
| Not yet recruiting | |
| Macerata, Italy, 62100 | |
| Not yet recruiting | |
| Lecce, Italy, 73100 | |
| Recruiting | |
| Lucca, Italy, 55100 | |
| Recruiting | |
| Chieti, Italy, 66100 | |
| Not yet recruiting | |
| Sassari, Italy, 07100 | |
| Not yet recruiting | |
| Cosenza, Italy, 87100 | |
| Recruiting | |
| Milano, Italy, 20142 | |
| Not yet recruiting | |
| Roma, Italy, 00135 | |
| Not yet recruiting | |
| Foggia, Italy, 71100 | |
| Recruiting | |
| Torino, Italy, 10149 | |
| Not yet recruiting | |
| Messina, Italy, 98125 | |
| Not yet recruiting | |
| Palermo, Italy, 90146 | |
| Recruiting | |
| Benevento, Italy, 82100 | |
| Not yet recruiting | |
| Roma, Italy, 00184 | |
| Not yet recruiting | |
| Roma, Italy, 00168 | |
| Not yet recruiting | |
| Udine, Italy, 33100 | |
| Not yet recruiting | |
| Catania, Italy, 95124 | |
| Not yet recruiting | |
| Brescia, Italy, 25123 | |
| Recruiting | |
| Ascoli Piceno, Italy, 63100 | |
| Italy, Pesaro e Urbino | |
| Not yet recruiting | |
| Pesaro, Pesaro e Urbino, Italy, 61100 | |
| Italy, Salerno | |
| Not yet recruiting | |
| Nocera Inferiore, Salerno, Italy, 84014 | |
| Italy, Treviso | |
| Not yet recruiting | |
| Pieve di Soligo, Treviso, Italy, 31053 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer S.p.A. ( Therapeutic Area Head ) |
| Study ID Numbers: | 12669, 2007-001320-12 |
| Study First Received: | July 16, 2008 |
| Last Updated: | September 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00717561 History of Changes |
| Health Authority: | Italy: The Italian Medicines Agency |
|
CAP Community-acquired pneumonia |
|
Anti-Infective Agents Amoxicillin Molecular Mechanisms of Pharmacological Action Clavulanic Acids Enzyme Inhibitors Ceftriaxone Amoxicillin-Potassium Clavulanate Combination Pharmacologic Actions Protein Synthesis Inhibitors Clarithromycin |
Anti-Bacterial Agents Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin Therapeutic Uses Lung Diseases Azithromycin Clavulanic Acid Pneumonia |