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

NCT ID: NCT01045902

Last Updated: 2010-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2005-01-31

Brief Summary

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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

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Conditions

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Pneumonia, Aspiration Lung Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type DRUG

Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od

Arm 2

Group Type ACTIVE_COMPARATOR

Sulbactam/Ampicillin

Intervention Type DRUG

Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid

Interventions

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Avelox (Moxifloxacin, BAY12-8039)

Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od

Intervention Type DRUG

Sulbactam/Ampicillin

Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Mannheim, Baden-Wurttemberg, Germany

Site Status

Nuremberg, Bavaria, Germany

Site Status

Regensburg, Bavaria, Germany

Site Status

Treuenbrietzen, Brandenburg, Germany

Site Status

Frankfurt am Main, Hesse, Germany

Site Status

Hildesheim, Lower Saxony, Germany

Site Status

Rotenburg (Wümme), Lower Saxony, Germany

Site Status

Lüdenscheid, North Rhine-Westphalia, Germany

Site Status

Oberhausen, North Rhine-Westphalia, Germany

Site Status

Paderborn, North Rhine-Westphalia, Germany

Site Status

Leipzig, Saxony, Germany

Site Status

Magdeburg, Saxony-Anhalt, Germany

Site Status

Lübeck, Schleswig-Holstein, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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10381

Identifier Type: -

Identifier Source: org_study_id

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