Official Title: “A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia”

This study compared the safety and efficacy of Avelox® vs. Levaquin® for the treatment of Community Acquired Pneumonia (CAP) in patients >= 65 years of age.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

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.

Intervention(s) in this Clinical Trial

• 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
• Drug: Levofloxacin
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes
• Adverse Events
  • Time Frame: Up to 7-14 days post-therapy
    Safety Issue?: Yes
• Clinical Response
  • Time Frame: Day 3-5 during treament, 7-14 days post-therapy
    Safety Issue?: No
• Mortality attributable to pneumonia
  • Time Frame: 7-14 days post-therapy
    Safety Issue?: Yes
• Bacteriological Response
  • Time Frame: 7-14 days post-therapy
    Safety Issue?: No
• Overall cost of hospitalization
  • Time Frame: Up to 7-14 days post-therapy
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00665327

Study ID Number: 10872

ClinicalTrials.gov Identifier: NCT00665327

Health Authority: United States: Food and Drug Administration

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