Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00665327
• Collaborator: (none)
• Enrollment: 401
• Locations: 77
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Levofloxacin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
• Study Start Date: Nov 1, 2002
• Actual Primary Completion Date: Apr 1, 2004
• Actual Study Completion Date: Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

2. Adverse Events Collection [Up to 7-14 days post-therapy]

3. Clinical Response [Day 3-5 during treament, 7-14 days post-therapy]

4. Mortality attributable to pneumonia [7-14 days post-therapy]

5. Bacteriological Response [7-14 days post-therapy]

6. Overall cost of hospitalization [Up to 7-14 days post-therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Mobile	Alabama	United States	36608-1798
2		Tucson	Arizona	United States	85723
3		Tucson	Arizona	United States	85724
4		Brea	California	United States	92821-3075
5		Fullerton	California	United States	92835-3800
6		La Jolla	California	United States	92093
7		Madera	California	United States	93637
8		Bridgeport	Connecticut	United States	06610
9		Farmington	Connecticut	United States	06030
10		Stamford	Connecticut	United States	06902-3628
11		Brandon	Florida	United States	33511
12		Jacksonville	Florida	United States	32209
13		Orlando	Florida	United States	32806-2093
14		Sarasota	Florida	United States	34239
15		Tampa	Florida	United States	33606-3508
16		Austell	Georgia	United States	30106-8116
17		Blue Ridge	Georgia	United States	30513
18		Columbus	Georgia	United States	31902
19		Fort Gordon	Georgia	United States	30905
20		Marietta	Georgia	United States	30060
21		Honolulu	Hawaii	United States	96817
22		Coeur d'Alene	Idaho	United States	83814-4487
23		Elk Grove Village	Illinois	United States	60007
24		Springfield	Illinois	United States	62703
25		Fort Wayne	Indiana	United States	46802-1493
26		Indianapolis	Indiana	United States	46202-2879
27		Indianapolis	Indiana	United States	46280
28		Lexington	Kentucky	United States	40536
29		New Orleans	Louisiana	United States	70112
30		New Orleans	Louisiana	United States	70122
31		New Orleans	Louisiana	United States	70127-3154
32		Shreveport	Louisiana	United States	71130-4228
33		Cumberland	Maryland	United States	21502
34		Kalamazoo	Michigan	United States	49048-1666
35		Royal Oak	Michigan	United States	48073-6769
36		Duluth	Minnesota	United States	55805-1984
37		Columbia	Missouri	United States	65212
38		St. Louis	Missouri	United States	63110-1094
39		Anaconda	Montana	United States	59711-2718
40		Omaha	Nebraska	United States	68105
41		Holmdel	New Jersey	United States	07733
42		Neptune	New Jersey	United States	07753
43		Newark	New Jersey	United States	07712-2027
44		Albany	New York	United States	12208-3473
45		Johnson City	New York	United States	13790
46		Kingston	New York	United States	12401
47		Manhasset	New York	United States	11030-3876
48		Mineola	New York	United States	11501
49		New York	New York	United States	10016-9198
50		New York	New York	United States	10029
51		Syracuse	New York	United States	13210-2399
52		Chapel Hill	North Carolina	United States	27599-7065
53		Elizabeth City	North Carolina	United States	27909
54		Winston-Salem	North Carolina	United States	27103
55		Winston-Salem	North Carolina	United States	27157
56		Akron	Ohio	United States	44304
57		Columbus	Ohio	United States	43214-3998
58		Dayton	Ohio	United States	45428
59		Lima	Ohio	United States	45801
60		Tulsa	Oklahoma	United States	74136-1902
61		Allentown	Pennsylvania	United States	18102
62		Beaver	Pennsylvania	United States	15009
63		Hershey	Pennsylvania	United States	17033-0850
64		Philadelphia	Pennsylvania	United States	19102
65		Summerville	South Carolina	United States	29485
66		Jackson	Tennessee	United States	38301-3855
67		Knoxville	Tennessee	United States	37920
68		Memphis	Tennessee	United States	38104
69		El Paso	Texas	United States	79905-2709
70		San Antonio	Texas	United States	78217-0156
71		San Antonio	Texas	United States	78229
72		San Antonio	Texas	United States	78236-5300
73		San Antonio	Texas	United States	78284-5799
74		Salt Lake City	Utah	United States	84102
75		Lynchburg	Virginia	United States	24501-1109
76		Norfolk	Virginia	United States	23507
77		San Juan		Puerto Rico	00921-3201

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00665327
• Other Study ID Numbers: 10872
• First Posted: Apr 23, 2008
• Last Update Posted: Nov 18, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Bayer: Community Acquired Pneumonia; Pneumonia,; CAP
• Additional relevant MeSH terms: Pneumonia; Moxifloxacin; Levofloxacin; Ofloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Nov 18, 2014