Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

NCT00665327 | Completed Phase 4

• 1 other identifier: 10872
• Study Type: interventional
• Target: 401
• Locations: 2 countries
• Sites: 77

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.

Conditions

Pneumonia

Keywords

Community Acquired Pneumonia; Pneumonia,; CAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Arm 2

ACTIVE COMPARATOR

Drug: Levofloxacin

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

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

Arm 1

Levofloxacin DRUG

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

Arm 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (77)

Unknown Facility

Mobile, Alabama, 36608-1798, United States

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Tucson, Arizona, 85723, United States

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Tucson, Arizona, 85724, United States

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Brea, California, 92821-3075, United States

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Fullerton, California, 92835-3800, United States

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La Jolla, California, 92093, United States

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Madera, California, 93637, United States

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Bridgeport, Connecticut, 06610, United States

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Farmington, Connecticut, 06030, United States

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Stamford, Connecticut, 06902-3628, United States

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Brandon, Florida, 33511, United States

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Jacksonville, Florida, 32209, United States

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Orlando, Florida, 32806-2093, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33606-3508, United States

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Austell, Georgia, 30106-8116, United States

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Blue Ridge, Georgia, 30513, United States

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Columbus, Georgia, 31902, United States

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Fort Gordon, Georgia, 30905, United States

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Marietta, Georgia, 30060, United States

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Honolulu, Hawaii, 96817, United States

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Coeur d'Alene, Idaho, 83814-4487, United States

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Elk Grove Village, Illinois, 60007, United States

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Springfield, Illinois, 62703, United States

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Fort Wayne, Indiana, 46802-1493, United States

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Indianapolis, Indiana, 46202-2879, United States

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Indianapolis, Indiana, 46280, United States

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Lexington, Kentucky, 40536, United States

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New Orleans, Louisiana, 70112, United States

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New Orleans, Louisiana, 70122, United States

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New Orleans, Louisiana, 70127-3154, United States

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Shreveport, Louisiana, 71130-4228, United States

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Cumberland, Maryland, 21502, United States

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Kalamazoo, Michigan, 49048-1666, United States

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Royal Oak, Michigan, 48073-6769, United States

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Duluth, Minnesota, 55805-1984, United States

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Columbia, Missouri, 65212, United States

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St Louis, Missouri, 63110-1094, United States

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Anaconda, Montana, 59711-2718, United States

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Omaha, Nebraska, 68105, United States

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Holmdel, New Jersey, 07733, United States

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Neptune City, New Jersey, 07753, United States

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Newark, New Jersey, 07712-2027, United States

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Albany, New York, 12208-3473, United States

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Johnson City, New York, 13790, United States

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Kingston, New York, 12401, United States

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Manhasset, New York, 11030-3876, United States

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Mineola, New York, 11501, United States

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New York, New York, 10016-9198, United States

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New York, New York, 10029, United States

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Syracuse, New York, 13210-2399, United States

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Chapel Hill, North Carolina, 27599-7065, United States

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Elizabeth City, North Carolina, 27909, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27157, United States

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Akron, Ohio, 44304, United States

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Columbus, Ohio, 43214-3998, United States

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Dayton, Ohio, 45428, United States

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Lima, Ohio, 45801, United States

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Tulsa, Oklahoma, 74136-1902, United States

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Allentown, Pennsylvania, 18102, United States

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Beaver, Pennsylvania, 15009, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Philadelphia, Pennsylvania, 19102, United States

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Summerville, South Carolina, 29485, United States

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Jackson, Tennessee, 38301-3855, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38104, United States

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El Paso, Texas, 79905-2709, United States

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San Antonio, Texas, 78217-0156, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78236-5300, United States

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San Antonio, Texas, 78284-5799, United States

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Salt Lake City, Utah, 84102, United States

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Lynchburg, Virginia, 24501-1109, United States

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Norfolk, Virginia, 23507, United States

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San Juan, 00921-3201, Puerto Rico

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MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Interventions

Moxifloxacin; Levofloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 23, 2008
• Study Start: November 1, 2002
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

US (76); PR (1)