NCT00665327CompletedPhase 4
A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 401
- Primary Endpoint
- Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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.
Arms & Interventions
Arm 1
Experimental
Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Arm 2
Active Comparator
Intervention: Levofloxacin (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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(First 72 hours of study participation)
- Adverse Events Collection(Up to 7-14 days post-therapy)
- Clinical Response(Day 3-5 during treament, 7-14 days post-therapy)
- Mortality attributable to pneumonia(7-14 days post-therapy)
- Bacteriological Response(7-14 days post-therapy)
- Overall cost of hospitalization(Up to 7-14 days post-therapy)
Investigators
Similar Trials
Completed
Phase 3
BAY12-8039: 5 Days for Sinusitis vs PlaceboSinusitisNCT00492024Bayer374
Completed
Not Applicable
Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory DiseaseAnti-Infective AgentsNCT01690533Bayer497
Terminated
Phase 2
Docetaxel Plus Bevacizumab for Elderly Patients With Stage IV NSCLCNSCLCNCT02179567Hellenic Oncology Research Group26
Completed
Phase 4
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major DepressionDepressionNCT00177528University of Pittsburgh70
Completed
Phase 3
A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIsInfectious DiseasesNCT00828971Bayer16