Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

Pneumonia Clinical Trial

Official title:

A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665327
• Other study ID #: 10872
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: November 17, 2014
• Start date: November 2002
• Est. completion date: April 2004

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings		First 72 hours of study participation	Yes
Secondary	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		First 72 hours of study participation	Yes
Secondary	Adverse Events Collection		Up to 7-14 days post-therapy	Yes
Secondary	Clinical Response		Day 3-5 during treament, 7-14 days post-therapy	No
Secondary	Mortality attributable to pneumonia		7-14 days post-therapy	Yes
Secondary	Bacteriological Response		7-14 days post-therapy	No
Secondary	Overall cost of hospitalization		Up to 7-14 days post-therapy	No

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