Pneumonia
Conditions
Keywords
Community Acquired Pneumonia, Pneumonia,, CAP
Brief summary
This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly subjects (aged ≥ 65 years) with community-acquired pneumonia (CAP) who required initial IV therapy. This study also included an assessment of the clinical and bacteriologic effectiveness of both drugs.
Interventions
Moxifloxacin 400 mg IV QD for a minimum of two doses followed by moxifloxacin 400 mg PO QD for a total treatment duration of 7 to 14 days
DRUGLevofloxacin
Levofloxacin 500 mg IV QD for a minimum of two doses followed by Levofloxacin 500 mg PO QD for a total treatment duration of 7 to 14 days. For patients who have a documented or calculated creatinine clearance of 20 - 49 ml/minute, the IV and PO dose of Levofloxacin will be a 500 mg loading dose followed by 250 mg QD for a total treatment duration of 7 to 14 days
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of radiological evidence of a new or progressive infiltrate(s) consistent with bacterial pneumonia and at least 2 of the following: * Productive cough with purulent or mucopurulent sputum/tracheobronchial secretions or change in the character of sputum (increased volume or purulence) * Dyspnea or tachypnea * Rigors or chills- Pleuritic chest pain * Auscultatory findings on pulmonary examination of rales/crackles and/or evidence of pulmonary consolidation- Fever or hypothermia * White blood cell count \>/= 10000/mm3 or \>/= 15% immature neutrophils, regardless of the peripheral WBC count, or leukopenia with total WBC count \< 4500/mm3
Exclusion criteria
* Known hypersensitivity to fluoroquinolones- Presence of end-organ damage or shock with need for vasopressors for \> 4 hours at the time of study entry * Need for mechanical ventilation at study entry * Implanted cardiac defibrillator.- Significant bradycardia with heart rate \< 50 beats/minute. * Hospitalized for \> 48 hours before developing pneumonia. * Systemic antibacterial therapy for more than 24 hours within 7 days of enrollment unless the patient was deemed a treatment failure after receiving greater than 72 hours of a non-fluoroquinolone antibiotic. * Co-existent disease considered likely to affect the outcome of the study (e.g. active lung cancer, connective tissue disease affecting the lungs, bronchiectasis). * Mechanical endobronchial obstruction (e.g. endobronchial tumor). * Known or suspected active tuberculosis or endemic fungal infection * Neutropenia (neutrophil count \< 1000/Microliter). * Chronic treatment (equal or longer than 2 weeks) with known immunosuppressant therapy (including treatment with \> 15 mg/day of systemic prednisone or equivalent). * Patient with known HIV infection and a CD4 count \< 200/mm3 . * Known severe hepatic insufficiency . * Renal impairment with a baseline measured or calculated serum creatinine clearance \< 20 mL/min. If a recent value for a 24 hour creatinine clearance is not available then the creatinine clearance should be calculated using the Cockcroft-Gault formula . * Known prolongation of the QT interval or use of Class IA or Class III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol). * Uncorrected hypokalemia. * Previous history of tendinopathy with quinolones. * Previously entered in this study.- Participated in any clinical investigational drug study within 4 weeks of screening. * Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment. * Patients with a history of a hypersensitivity reaction to multivitamin infusion (MVI) or pre-existing hypervitaminosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings | First 72 hours of study participation |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events Collection | Up to 7-14 days post-therapy |
| Clinical Response | Day 3-5 during treament, 7-14 days post-therapy |
| Incidence of a composite safety end point (including atrial fibrillation sustained and unsustained supraventricular tachycardia, third degree AV block and long RR pauses), based on Holter | First 72 hours of study participation |
| Bacteriological Response | 7-14 days post-therapy |
| Overall cost of hospitalization | Up to 7-14 days post-therapy |
| Mortality attributable to pneumonia | 7-14 days post-therapy |
Countries
Puerto Rico, United States
Outcome results
None listed