check_circleStudy Completed

Pneumonia

Avelox for treatment of Elderly Patients with Community Acquired Pneumonia

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

65 Years

Trial summary

Enrollment Goal
401
Trial Dates
November 2002 - April 2004
Phase
Phase 4
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Omaha Divison VA Nebraska W.Iowa Health Care SystemOmaha, 68105, United States
Completed
St. Mary's/Duluth Clinic Health SystemDuluth, 55805-1984, United States
Completed
Southern Arizona Veterans Affairs Health Care SystemTucson, 85723, United States
Completed
Carolina Research SpecialistsElizabeth City, 27909, United States
Completed
Bayshore Community HospitalHolmdel, 07733, United States
Completed
Wellstar Infectious Disease, LLCMarietta, 30060, United States
Completed
Bridgeport HospitalBridgeport, 06610, United States
Terminated
Wilson Memorial Regional Medical CenterJohnson City, 13790, United States
Terminated
Wilford Hall US Airforce Medical CenterSan Antonio, 78236-5300, United States
Terminated
Drexel University College of MedicinePhiladelphia, 19102, United States
Terminated
University of Florida - JacksonvilleJacksonville, 32209, United States
Completed
TriState Medical Group, Inc.Beaver, 15009, United States
Completed
Newark Beth Israel Medical CenterNewark, 07712-2027, United States
Completed
The Medical CenterColumbus, 31902, United States
Completed
Veterans' Affairs Medical CenterDayton, 45428, United States
Terminated
Springhill Medical CenterMobile, 36608-1798, United States
Completed
Medical Center of Louisiana at New OrleansNew Orleans, 70112, United States
Terminated
Sarasota Memorial HospitalSarasota, 34239, United States
Completed
Grant/Riverside Methodist HospitalColumbus, 43214-3998, United States
Completed
Eisenhower Army Medical CenterFort Gordon, 30905, United States
Completed
Lynchburg General HospitalLynchburg, 24501-1109, United States
Completed
Pulmonary Consultants of North IdahoCoeur d'Alene, 83814-4487, United States
Completed
Springfield ClinicSpringfield, 62703, United States
Completed
Horizon Research Center, Inc.Blue Ridge, 30513, United States
Completed
Wishard Memorial HospitalIndianapolis, 46202-2879, United States
Completed
LSU Health Sciences CenterShreveport, 71130-4228, United States
Completed
Mount Sinai Medical CenterNew York, 10029, United States
Terminated
Methodist Le Bonheur HealthcareMemphis, 38104, United States
Completed
Pulmonary Associates of Brandon Clinical ResearchBrandon, 33511, United States
Completed
Jackson-Madison County General HospitalJackson, 38301-3855, United States
Completed
Office of Dr. Judy StoneCumberland, 21502, United States
Completed
Anaconda Internal Medicine ClinicAnaconda, 59711-2718, United States
Terminated
Wilford Hall US Airforce Medical CenterSan Antonio, 78236-5300, United States
Terminated
Jersey Shore University Medical CenterNeptune, 07753, United States
Terminated
University of Arizona Health Science CenterTucson, 85724, United States
Terminated
University of KentuckyLexington, 40536, United States
Terminated
Texas Tech University Health Science CenterEl Paso, 79905-2709, United States
Completed
Sacred Heart Clinical ResearchAllentown, 18102, United States
Terminated
Bellevue Hospital CenterNew York, 10016-9198, United States
Terminated
Upstate Medical UniversitySyracuse, 13210-2399, United States
Terminated
Wake Forest UniversityWinston-Salem, 27157, United States
Completed
California Research Medical Group, Inc.Fullerton, 92835-3800, United States
Terminated
Hudson Valley Clinical ResearchKingston, 12401, United States
Terminated
Regional Infectious DiseasesLima, 45801, United States
Terminated
University of Tennessee Medical CenterKnoxville, 37920, United States
Completed
University of Connecticut Health CenterFarmington, 06030, United States
Completed
Akron Infectious DiseaseAkron, 44304, United States
Terminated
Office of Dr. Burke Cunha, MDMineola, 11501, United States
Terminated
Tampa General HospitalTampa, 33606-3508, United States
Terminated
University of Missouri School of MedicineColumbia, 65212, United States
Completed
Penn State Milton S. Hershey Medical CenterHershey, 17033-0850, United States
Completed
William Beaumont HospitalRoyal Oak, 48073-6769, United States
Terminated
Infectious Disease of Indiana, PSCIndianapolis, 46280, United States
Terminated
North Shore University HospitalManhasset, 11030-3876, United States
Terminated
Regional Infectious DiseasesLima, 45801, United States
Completed
Respiratory & Intensive Care AssociatesSan Antonio, 78217-0156, United States
Completed
South Texas Veterans Health Care SystemSan Antonio, 78284-5799, United States
Completed
Stratton Veterans Affairs Medical CenterAlbany, 12208-3473, United States
Completed
Madera Pulmonary & Sleep Disorder, Inc.Madera, 93637, United States
Terminated
St. Francis Medical CenterHonolulu, 96817, United States
Completed
Salt Lake Regional Medical CenterSalt Lake City, 84102, United States
Completed
UCSD-Clinical Trials CenterLa Jolla, 92093, United States
Terminated
Office of Dr. Adrian James, MDNew Orleans, 70122, United States
Completed
Pendleton Memorial Methodist HospitalNew Orleans, 70127-3154, United States
Completed
San Juan VA Medical CenterSan Juan, 00921-3201, United States
Completed
Brea Community HospitalBrea, 92821-3075, United States
Terminated
St. Joseph HospitalFort Wayne, 46802-1493, United States
Completed
Borgess Medical CenterKalamazoo, 49048-1666, United States
Terminated
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
Radiant ResearchAustell, 30106-8116, United States
Completed
St. Francis HospitalTulsa, 74136-1902, United States
Completed
University of North CarolinaChapel Hill, 27599-7065, United States
Terminated
Stamford HospitalStamford, 06902-3628, United States
Completed
Lung DiagnosticsSan Antonio, 78229, United States
Completed
Orlando Regional Medical CenterOrlando, 32806-2093, United States
Terminated
Barnes-Jewish HospitalSt. Louis, 63110-1094, United States
Terminated
Pulmonary Associates of Brandon Clinical ResearchBrandon, 33511, United States
Completed
All-Trials Clinical ResearchWinston-Salem, 27103, United States
Completed
Palmetto Clinical ResearchSummerville, 29485, United States
Terminated
Radiant ResearchElk Grove Village, 60007, United States

Primary Outcome

  • Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
    date_rangeTime Frame:
    First 72 hours of study participation
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • 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
    date_rangeTime Frame:
    First 72 hours of study participation
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse Events Collection
    date_rangeTime Frame:
    Up to 7-14 days post-therapy
    enhanced_encryption
    Safety Issue:
    yes
  • Clinical Response
    date_rangeTime Frame:
    Day 3-5 during treament, 7-14 days post-therapy
    enhanced_encryption
    Safety Issue:
    no
  • Mortality attributable to pneumonia
    date_rangeTime Frame:
    7-14 days post-therapy
    enhanced_encryption
    Safety Issue:
    yes
  • Bacteriological Response
    date_rangeTime Frame:
    7-14 days post-therapy
    enhanced_encryption
    Safety Issue:
    no
  • Overall cost of hospitalization
    date_rangeTime Frame:
    Up to 7-14 days post-therapy
    enhanced_encryption
    Safety Issue:
    no

Trial design

A Study of Avelox for Treatment of Elderly Patients with Community Acquired Pneumonia
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2