Clinical trial NCT00665327: Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
Official title: A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Keywords: Community Acquired Pneumonia
Pneumonia,
CAP
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 401
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&#8805; 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
timeFrame: First 72 hours of study participation
Secondary outcomes:
measure: 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
timeFrame: First 72 hours of study participation
measure: Adverse Events Collection
timeFrame: Up to 7-14 days post-therapy
measure: Clinical Response
timeFrame: Day 3-5 during treament, 7-14 days post-therapy
measure: Mortality attributable to pneumonia
timeFrame: 7-14 days post-therapy
measure: Bacteriological Response
timeFrame: 7-14 days post-therapy
measure: Overall cost of hospitalization
timeFrame: Up to 7-14 days post-therapy
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Brea
country: United States
state: California
city: Fullerton
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Madera
country: United States
state: California
city: Bridgeport
country: United States
state: Connecticut
city: Farmington
country: United States
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Brandon
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Austell
country: United States
state: Georgia
city: Blue Ridge
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Fort Gordon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Coeur d'Alene
country: United States
state: Idaho
city: Elk Grove Village
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Kalamazoo
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Anaconda
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Holmdel
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Elizabeth City
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Beaver
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Summerville
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: