Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00665327
First received: April 18, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Adverse Events Collection [ Time Frame: Up to 7-14 days post-therapy ] [ Designated as safety issue: Yes ]
  • Clinical Response [ Time Frame: Day 3-5 during treament, 7-14 days post-therapy ] [ Designated as safety issue: No ]
  • Mortality attributable to pneumonia [ Time Frame: 7-14 days post-therapy ] [ Designated as safety issue: Yes ]
  • Bacteriological Response [ Time Frame: 7-14 days post-therapy ] [ Designated as safety issue: No ]
  • Overall cost of hospitalization [ Time Frame: Up to 7-14 days post-therapy ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665327

  Show 77 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00665327     History of Changes
Other Study ID Numbers: 10872
Study First Received: April 18, 2008
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Community Acquired Pneumonia
Pneumonia,
CAP

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014