Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
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|ClinicalTrials.gov Identifier: NCT00665327|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : November 18, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||April 2004|
|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
- 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 ]
- 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 ]
- Adverse Events Collection [ Time Frame: Up to 7-14 days post-therapy ]
- Clinical Response [ Time Frame: Day 3-5 during treament, 7-14 days post-therapy ]
- Mortality attributable to pneumonia [ Time Frame: 7-14 days post-therapy ]
- Bacteriological Response [ Time Frame: 7-14 days post-therapy ]
- Overall cost of hospitalization [ Time Frame: Up to 7-14 days post-therapy ]
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|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665327
|Study Director:||Bayer Study Director||Bayer|
|Other Study ID Numbers:||
|First Posted:||April 23, 2008 Key Record Dates|
|Last Update Posted:||November 18, 2014|
|Last Verified:||November 2014|
Community Acquired Pneumonia
Respiratory Tract Infections
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