BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
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
1 other identifier
interventional
139
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2001
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 8, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedJanuary 11, 2010
January 1, 2010
January 8, 2010
January 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Up to 30 days after end of treatment with study medication for serious adverse events
Secondary Outcomes (1)
Clinical Response
Regulary doing i.v. treatment
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od
Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (15)
Unknown Facility
Mannheim, Baden-Wurttemberg, 68167, Germany
Unknown Facility
Nuremberg, Bavaria, 90419, Germany
Unknown Facility
Regensburg, Bavaria, 93053, Germany
Unknown Facility
Treuenbrietzen, Brandenburg, 14929, Germany
Unknown Facility
Frankfurt am Main, Hesse, 60596, Germany
Unknown Facility
Hildesheim, Lower Saxony, 31134, Germany
Unknown Facility
Rotenburg (Wümme), Lower Saxony, 27356, Germany
Unknown Facility
Lüdenscheid, North Rhine-Westphalia, 58515, Germany
Unknown Facility
Oberhausen, North Rhine-Westphalia, 46045, Germany
Unknown Facility
Paderborn, North Rhine-Westphalia, 33098, Germany
Unknown Facility
Leipzig, Saxony, 04129, Germany
Unknown Facility
Magdeburg, Saxony-Anhalt, 39112, Germany
Unknown Facility
Lübeck, Schleswig-Holstein, 23538, Germany
Unknown Facility
Berlin, State of Berlin, 13353, Germany
Unknown Facility
Berlin, State of Berlin, 14165, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2010
First Posted
January 11, 2010
Study Start
February 1, 2001
Study Completion
January 1, 2005
Last Updated
January 11, 2010
Record last verified: 2010-01