Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

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 Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Levofloxacin

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921-3201
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608-1798
  • Arizona
    • Tucson, Arizona, United States, 85724
    • Tucson, Arizona, United States, 85723
  • California
    • Brea, California, United States, 92821-3075
    • Fullerton, California, United States, 92835-3800
    • La Jolla, California, United States, 92093
    • Madera, California, United States, 93637
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
    • Farmington, Connecticut, United States, 06030
    • Stamford, Connecticut, United States, 06902-3628
  • Florida
    • Brandon, Florida, United States, 33511
    • Jacksonville, Florida, United States, 32209
    • Orlando, Florida, United States, 32806-2093
    • Sarasota, Florida, United States, 34239
    • Tampa, Florida, United States, 33606-3508
  • Georgia
    • Austell, Georgia, United States, 30106-8116
    • Blue Ridge, Georgia, United States, 30513
    • Columbus, Georgia, United States, 31902
    • Fort Gordon, Georgia, United States, 30905
    • Marietta, Georgia, United States, 30060
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814-4487
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
    • Springfield, Illinois, United States, 62703
  • Indiana
    • Fort Wayne, Indiana, United States, 46802-1493
    • Indianapolis, Indiana, United States, 46202-2879
    • Indianapolis, Indiana, United States, 46280
  • Kentucky
    • Lexington, Kentucky, United States, 40536
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
    • New Orleans, Louisiana, United States, 70122
    • New Orleans, Louisiana, United States, 70127-3154
    • Shreveport, Louisiana, United States, 71130-4228
  • Maryland
    • Cumberland, Maryland, United States, 21502
  • Michigan
    • Kalamazoo, Michigan, United States, 49048-1666
    • Royal Oak, Michigan, United States, 48073-6769
  • Minnesota
    • Duluth, Minnesota, United States, 55805-1984
  • Missouri
    • Columbia, Missouri, United States, 65212
    • St. Louis, Missouri, United States, 63110-1094
  • Montana
    • Anaconda, Montana, United States, 59711-2718
  • Nebraska
    • Omaha, Nebraska, United States, 68105
  • New Jersey
    • Holmdel, New Jersey, United States, 07733
    • Neptune, New Jersey, United States, 07753
    • Newark, New Jersey, United States, 07712-2027
  • New York
    • Albany, New York, United States, 12208-3473
    • Johnson City, New York, United States, 13790
    • Kingston, New York, United States, 12401
    • Manhasset, New York, United States, 11030-3876
    • Mineola, New York, United States, 11501
    • New York, New York, United States, 10029
    • New York, New York, United States, 10016-9198
    • Syracuse, New York, United States, 13210-2399
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7065
    • Elizabeth City, North Carolina, United States, 27909
    • Winston-Salem, North Carolina, United States, 27103
    • Winston-Salem, North Carolina, United States, 27157
  • Ohio
    • Akron, Ohio, United States, 44304
    • Columbus, Ohio, United States, 43214-3998
    • Dayton, Ohio, United States, 45428
    • Lima, Ohio, United States, 45801
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-1902
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
    • Beaver, Pennsylvania, United States, 15009
    • Hershey, Pennsylvania, United States, 17033-0850
    • Philadelphia, Pennsylvania, United States, 19102
  • South Carolina
    • Summerville, South Carolina, United States, 29485
  • Tennessee
    • Jackson, Tennessee, United States, 38301-3855
    • Knoxville, Tennessee, United States, 37920
    • Memphis, Tennessee, United States, 38104
  • Texas
    • El Paso, Texas, United States, 79905-2709
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78217-0156
    • San Antonio, Texas, United States, 78236-5300
    • San Antonio, Texas, United States, 78284-5799
  • Utah
    • Salt Lake City, Utah, United States, 84102
  • Virginia
    • Lynchburg, Virginia, United States, 24501-1109
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings	First 72 hours of study participation

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: CAP; Community Acquired Pneumonia; Pneumonia,
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Levofloxacin; Ofloxacin
• Other Study ID Numbers: 10872 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)