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
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 April 16, 2014