Back to resultsBAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
Primary Purpose
Pneumonia, Aspiration, Lung Abscess
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Avelox (Moxifloxacin, BAY12-8039)
Sulbactam/Ampicillin
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Aspiration focused on measuring Pulmonary Abscess, Aspiration Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged 18 years or above
- The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment
Exclusion Criteria:
- Known hypersensitivity to fluoroquinolones and/or ß-lactams
- Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Secondary Outcome Measures
Clinical Response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01045902
Brief Title
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
Official Title
Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Aspiration, Lung Abscess
Keywords
Pulmonary Abscess, Aspiration Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Avelox (Moxifloxacin, BAY12-8039)
Intervention Description
Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od
Intervention Type
Drug
Intervention Name(s)
Sulbactam/Ampicillin
Intervention Description
Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
Primary Outcome Measure Information:
Title
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Time Frame
Up to 30 days after end of treatment with study medication for serious adverse events
Secondary Outcome Measure Information:
Title
Clinical Response
Time Frame
Regulary doing i.v. treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged 18 years or above
The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment
Exclusion Criteria:
Known hypersensitivity to fluoroquinolones and/or ß-lactams
Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
City
Treuenbrietzen
State/Province
Brandenburg
ZIP/Postal Code
14929
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
City
Hildesheim
State/Province
Niedersachsen
ZIP/Postal Code
31134
Country
Germany
City
Rotenburg
State/Province
Niedersachsen
ZIP/Postal Code
27356
Country
Germany
City
Lüdenscheid
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58515
Country
Germany
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46045
Country
Germany
City
Paderborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33098
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04129
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Berlin
ZIP/Postal Code
14165
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
We'll reach out to this number within 24 hrs