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Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00665327
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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 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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Adverse Events Collection [ Time Frame: Up to 7-14 days post-therapy ]
  3. Clinical Response [ Time Frame: Day 3-5 during treament, 7-14 days post-therapy ]
  4. Mortality attributable to pneumonia [ Time Frame: 7-14 days post-therapy ]
  5. Bacteriological Response [ Time Frame: 7-14 days post-therapy ]
  6. Overall cost of hospitalization [ Time Frame: Up to 7-14 days post-therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00665327

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT00665327    
Other Study ID Numbers: 10872
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by Bayer:
Community Acquired Pneumonia
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Anti-Infective Agents, Urinary
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors