Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
This study has been completed.
Information provided by (Responsible Party):
First received: April 18, 2008
Last updated: October 9, 2013
Last verified: October 2013
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.
Drug: Avelox (Moxifloxacin, BAY12-8039)
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
Primary Outcome Measures:
- Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings [ Time Frame: First 72 hours of study participation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 [ Time Frame: First 72 hours of study participation ] [ Designated as safety issue: Yes ]
- Adverse Events Collection [ Time Frame: Up to 7-14 days post-therapy ] [ Designated as safety issue: Yes ]
- Clinical Response [ Time Frame: Day 3-5 during treament, 7-14 days post-therapy ] [ Designated as safety issue: No ]
- Mortality attributable to pneumonia [ Time Frame: 7-14 days post-therapy ] [ Designated as safety issue: Yes ]
- Bacteriological Response [ Time Frame: 7-14 days post-therapy ] [ Designated as safety issue: No ]
- Overall cost of hospitalization [ Time Frame: Up to 7-14 days post-therapy ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2004 (Final data collection date for primary outcome measure)
Experimental: Arm 1
Drug: Avelox (Moxifloxacin, BAY12-8039)
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
Active Comparator: Arm 2
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
|Ages Eligible for Study:
||65 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665327
||Bayer Study Director
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 18, 2008
||October 9, 2013
||United States: Food and Drug Administration
Keywords provided by Bayer:
Community Acquired Pneumonia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Respiratory Tract Diseases
Respiratory Tract Infections
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