Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

Bayer

Status and phase

Completed

Phase 4

Conditions

Pneumonia

Treatments

Drug: Levofloxacin

Drug: Avelox (Moxifloxacin, BAY12-8039)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00665327

10872

Details and patient eligibility

About

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.

Enrollment

401 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.