Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

• ClinicalTrials.gov Identifier: NCT00665327
• Recruitment Status: Completed
• First Posted: April 23, 2008
• Last Update Posted: November 18, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: April 18, 2008
• First Posted Date: April 23, 2008
• Last Update Posted Date: November 18, 2014
• Study Start Date: November 2002
• Actual Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 22, 2008): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 3, 2009)

• 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 ]
• Adverse Events Collection [ Time Frame: Up to 7-14 days post-therapy ]
• Clinical Response [ Time Frame: Day 3-5 during treament, 7-14 days post-therapy ]
• Mortality attributable to pneumonia [ Time Frame: 7-14 days post-therapy ]
• Bacteriological Response [ Time Frame: 7-14 days post-therapy ]
• Overall cost of hospitalization [ Time Frame: Up to 7-14 days post-therapy ]

Original Secondary Outcome Measures (submitted: April 22, 2008)

• 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 ]
• Adverse Events [ Time Frame: Up to 7-14 days post-therapy ]
• Clinical Response [ Time Frame: Day 3-5 during treament, 7-14 days post-therapy ]
• Mortality attributable to pneumonia [ Time Frame: 7-14 days post-therapy ]
• Bacteriological Response [ Time Frame: 7-14 days post-therapy ]
• Overall cost of hospitalization [ Time Frame: Up to 7-14 days post-therapy ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pneumonia

Intervention

• 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
• 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

Study Arms

• Experimental: Arm 1
  Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
• Active Comparator: Arm 2
  Intervention: Drug: Levofloxacin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2014): 401
• Original Actual Enrollment (submitted: April 22, 2008): 400
• Actual Study Completion Date: April 2004
• Actual Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT00665327
• Other Study ID Numbers: 10872
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bayer
• Original Responsible Party: Bayer Corporation, Therapeutic Area Head
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: November 2014