BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia

Phase 3

Completed

• Conditions: Pneumonia, Aspiration; Lung Abscess
• Interventions: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Sulbactam/Ampicillin

• Registration Number: NCT01045902
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study Completion: 2005-01
• Status Verified: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Last Update Submitted: 2010-01-08
• Study First Posted: 2010-01-11
• Last Update Posted: 2010-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Avelox (Moxifloxacin, BAY12-8039)	-
Arm 2	Sulbactam/Ampicillin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical Response	Regulary doing i.v. treatment