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Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

NCT ID: NCT00035347

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-06-30

Brief Summary

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A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.

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Detailed Description

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Conditions

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Community-Acquired Pneumonia (CAP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin plus ceftriaxone group (AZY+CEF group)

IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy

Group Type EXPERIMENTAL

IV azithromycin

Intervention Type DRUG

500 mg once daily

ceftriaxone

Intervention Type DRUG

1 gram once daily for 2 to 5 days

oral azithromycin

Intervention Type DRUG

2 x 250 mg once daily

Levofloxacin group (LEV group)

IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy.

Group Type EXPERIMENTAL

IV levofloxacin

Intervention Type DRUG

500 mg once daily

oral levofloxacin

Intervention Type DRUG

500 mg once daily

Interventions

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IV azithromycin

500 mg once daily

Intervention Type DRUG

ceftriaxone

1 gram once daily for 2 to 5 days

Intervention Type DRUG

oral azithromycin

2 x 250 mg once daily

Intervention Type DRUG

IV levofloxacin

500 mg once daily

Intervention Type DRUG

oral levofloxacin

500 mg once daily

Intervention Type DRUG

Other Intervention Names

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Zithromax® Rocephin® Zithromax® Levaquin® Levaquin®

Eligibility Criteria

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Inclusion Criteria

* Patient must be 18 years or older.
* Patient must be hospitalized and require intravenous therapy for treatment of pneumonia.
* Patient must have pneumonia as documented by relevant signs and symptoms and a positive chest X-ray.
* Patients cannot have certain underlying diseases or conditions as defined in the study protocol.

Exclusion Criteria

* Pregnant women, nursing mothers, or women of childbearing potential not practicing adequate contraception.
* Known or suspected hypersensitivity or intolerance to any quinolone, penicillin, cephalosporin, or macrolide antibiotic.
* Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to the baseline visit.
* Subjects with clinically significant renal dysfunction.
* Subjects with clinically significant hepatic dysfunction.
* Subjects with clinically significant cardiovascular disorders.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Long Beach, California, United States

Site Status

Pfizer Investigational Site

Sylmar, California, United States

Site Status

Pfizer Investigational Site

Sarasota, Florida, United States

Site Status

Pfizer Investigational Site

Columbus, Georgia, United States

Site Status

Pfizer Investigational Site

Columbus, Georgia, United States

Site Status

Pfizer Investigational Site

Fort Eisenhower, Georgia, United States

Site Status

Pfizer Investigational Site

Shawnee Mission, Kansas, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

Royal Oak, Michigan, United States

Site Status

Pfizer Investigational Site

Kirkwood, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Albuquerque, New Mexico, United States

Site Status

Pfizer Investigational Site

Mineola, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Sellersville, Pennsylvania, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Pfizer Investigational Site

Hamilton, Ontario, Canada

Site Status

Pfizer Investigational Site

London, Ontario, Canada

Site Status

Pfizer Investigational Site

Ottawa, Ontario, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Ste-foy, Quebec, Canada

Site Status

Pfizer Investigational Site

Regina, Saskatchewan, Canada

Site Status

Pfizer Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Pfizer Investigational Site

Rotenburg (Wümme), Lower Saxony, Germany

Site Status

Pfizer Investigational Site

Berlin, State of Berlin, Germany

Site Status

Pfizer Investigational Site

Lüdenscheid, , Germany

Site Status

Pfizer Investigational Site

Maroussi. Attikis, Athens, Greece

Site Status

Pfizer Investigational Site

Barcelona, Catalonia, Spain

Site Status

Pfizer Investigational Site

Tarrasa, Catalonia, Spain

Site Status

Countries

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United States Canada Germany Greece Spain

Other Identifiers

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A0661035

Identifier Type: -

Identifier Source: org_study_id

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