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

Pneumonia, Aspiration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045902
• Other study ID #: 10381
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2010
• Last updated: January 8, 2010
• Start date: February 2001
• Est. completion date: January 2005

Study information

• Verified date: January 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Lung Abscess
• Pneumonia
• Pneumonia, Aspiration

Intervention

Drug:
• Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od
• Sulbactam/Ampicillin
Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical Response		Regulary doing i.v. treatment	No

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