Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Levofloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin

Criteria

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.