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

Bayer

Status and phase: Completed; Phase 3

Conditions: Pneumonia, Aspiration; Lung Abscess

Treatments: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Sulbactam/Ampicillin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01045902

10381 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Avelox (Moxifloxacin, BAY12-8039)

Arm 2

Active Comparator group

Treatment:

Drug: Sulbactam/Ampicillin