Pneumonia, Aspiration, Lung Abscess
Conditions
Keywords
Pulmonary Abscess, Aspiration Pneumonia
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.
Interventions
Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od
DRUGSulbactam/Ampicillin
Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clinical Response | Regulary doing i.v. treatment |
Countries
Germany
Outcome results
None listed