PneumoniaPhase 4NCT00665327

Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

A Phase 4 study testing Avelox (Moxifloxacin, BAY12-8039) and Levofloxacin in people with Pneumonia, run by Bayer at 77 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Pneumonia
What is being tested?: Avelox (Moxifloxacin, BAY12-8039) and Levofloxacin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 401 participants
Where: 77 sitesin 2 countries
Study dates: Nov 2002to Apr 2004
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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).

Show all 19Show fewer

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.

Trial locations and contacts

77 sites in 2 countries.

Country

City, postcode or hospital

77 sites in 2 countries

United States76 sites

Study site
Akron, Ohio, 44304
Study site
Albany, New York, 12208-3473
Study site
Allentown, Pennsylvania, 18102
Study site
Anaconda, Montana, 59711-2718
Study site
Austell, Georgia, 30106-8116
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Beaver, Pennsylvania, 15009
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Blue Ridge, Georgia, 30513
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Brandon, Florida, 33511
Study site
Brea, California, 92821-3075
Study site
Bridgeport, Connecticut, 06610
Study site
Chapel Hill, North Carolina, 27599-7065
Study site
Coeur d'Alene, Idaho, 83814-4487
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Columbia, Missouri, 65212
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Columbus, Georgia, 31902
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Columbus, Ohio, 43214-3998
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Cumberland, Maryland, 21502
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Dayton, Ohio, 45428
Study site
Duluth, Minnesota, 55805-1984
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El Paso, Texas, 79905-2709
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Elizabeth City, North Carolina, 27909
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Elk Grove Village, Illinois, 60007
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Farmington, Connecticut, 06030
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Fort Gordon, Georgia, 30905
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Fort Wayne, Indiana, 46802-1493
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Fullerton, California, 92835-3800
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Hershey, Pennsylvania, 17033-0850
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Holmdel, New Jersey, 07733
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Honolulu, Hawaii, 96817
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Indianapolis, Indiana, 46202-2879
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Indianapolis, Indiana, 46280
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Jackson, Tennessee, 38301-3855
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Jacksonville, Florida, 32209
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Johnson City, New York, 13790
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Kalamazoo, Michigan, 49048-1666
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Kingston, New York, 12401
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Knoxville, Tennessee, 37920
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La Jolla, California, 92093
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Lexington, Kentucky, 40536
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Lima, Ohio, 45801
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Lynchburg, Virginia, 24501-1109
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Madera, California, 93637
Study site
Manhasset, New York, 11030-3876
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38104
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Mineola, New York, 11501
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Mobile, Alabama, 36608-1798
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Neptune City, New Jersey, 07753
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New Orleans, Louisiana, 70112
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New Orleans, Louisiana, 70122
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New Orleans, Louisiana, 70127-3154
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New York, New York, 10016-9198
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New York, New York, 10029
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Newark, New Jersey, 07712-2027
Study site
Norfolk, Virginia, 23507
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Omaha, Nebraska, 68105
Study site
Orlando, Florida, 32806-2093
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Philadelphia, Pennsylvania, 19102
Study site
Royal Oak, Michigan, 48073-6769
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Salt Lake City, Utah, 84102
Study site
San Antonio, Texas, 78217-0156
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San Antonio, Texas, 78229
Study site
San Antonio, Texas, 78236-5300
Study site
San Antonio, Texas, 78284-5799
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Sarasota, Florida, 34239
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Shreveport, Louisiana, 71130-4228
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Springfield, Illinois, 62703
Study site
St Louis, Missouri, 63110-1094
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Stamford, Connecticut, 06902-3628
Study site
Summerville, South Carolina, 29485
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Syracuse, New York, 13210-2399
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Tampa, Florida, 33606-3508
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Tucson, Arizona, 85723
Study site
Tucson, Arizona, 85724
Study site
Tulsa, Oklahoma, 74136-1902
Study site
Winston-Salem, North Carolina, 27103
Study site
Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico1 site

Study site
San Juan, 00921-3201

Other trials in Puerto Rico

About this study

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

Conditions: Pneumonia
Being tested: Avelox (Moxifloxacin, BAY12-8039), Levofloxacin
Keywords: Community Acquired Pneumonia, Pneumonia,, CAP
Medical subject headings: Pneumonia, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avelox (Moxifloxacin, BAY12-8039)Drug
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
LevofloxacinDrug
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 groups in NCT00665327
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2	Active comparator	Not described Receives: Drug: Levofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of a composite safety end point (including cardiac arrest, sustained and non-sustained ventricular tachycardia), based on digital Holter ECG recordings
Measured: First 72 hours of study participation

Secondary outcomes (6)

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
Measured: First 72 hours of study participation
Adverse Events Collection
Measured: Up to 7-14 days post-therapy
Clinical Response
Measured: Day 3-5 during treament, 7-14 days post-therapy
Mortality attributable to pneumonia
Measured: 7-14 days post-therapy
Bacteriological Response
Measured: 7-14 days post-therapy
Overall cost of hospitalization
Measured: Up to 7-14 days post-therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2002Apr 2004

First posted23 Apr 2008 (estimated)
Study startNov 2002
Primary completionApr 2004
Study completionApr 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PneumoniaStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 401 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00665327
Sponsor's protocol ID: 10872
Status last verified: Nov 2014
First submitted: 18 Apr 2008
Last updated: 18 Nov 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia
ClinicalTrials.gov ID: NCT00665327
Acronym / sponsor ID: 10872
Conditions: Pneumonia
Keywords: Community Acquired Pneumonia, Pneumonia,, CAP
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 401 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Nov 2002
Primary completion: Apr 2004 (actual)
Study completion: Apr 2004 (actual)
First posted: 23 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2	Active comparator	Drug: Levofloxacin

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Arm 1
LevofloxacinLevofloxacin 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	Drug	Arm 2

Primary outcome

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

6 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

77 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Avelox (Moxifloxacin, BAY12-8039) and Levofloxacin in people with Pneumonia, run by Bayer at 77 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00665327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.