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

NCT00035347 | Completed Phase 4

• 1 other identifier: A0661035
• Study Type: interventional
• Target: 219
• Locations: 5 countries
• Sites: 37

Brief Summary

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.

Conditions

Community-Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

• Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia.

  Duration of trial

Secondary Outcomes (1)

• Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen.

  Duration of trial

Study Arms (2)

Azithromycin plus ceftriaxone group (AZY+CEF group)

EXPERIMENTAL

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

Drug: IV azithromycin; Drug: ceftriaxone; Drug: oral azithromycin

Levofloxacin group (LEV group)

EXPERIMENTAL

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.

Drug: IV levofloxacin; Drug: oral levofloxacin

Interventions

IV azithromycin DRUG

500 mg once daily

Also known as: Zithromax®

Azithromycin plus ceftriaxone group (AZY+CEF group)

ceftriaxone DRUG

1 gram once daily for 2 to 5 days

Also known as: Rocephin®

Azithromycin plus ceftriaxone group (AZY+CEF group)

oral azithromycin DRUG

2 x 250 mg once daily

Also known as: Zithromax®

Azithromycin plus ceftriaxone group (AZY+CEF group)

IV levofloxacin DRUG

500 mg once daily

Also known as: Levaquin®

Levofloxacin group (LEV group)

oral levofloxacin DRUG

500 mg once daily

Also known as: Levaquin®

Levofloxacin group (LEV group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (37)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Long Beach, California, 90822, United States

Location

Pfizer Investigational Site

Sylmar, California, 91342, United States

Location

Pfizer Investigational Site

Sarasota, Florida, 34339, United States

Location

Pfizer Investigational Site

Columbus, Georgia, 31902, United States

Location

Pfizer Investigational Site

Columbus, Georgia, 31904, United States

Location

Pfizer Investigational Site

Fort Eisenhower, Georgia, 30905, United States

Location

Pfizer Investigational Site

Shawnee Mission, Kansas, 66204, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40206, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

Royal Oak, Michigan, 48073-6769, United States

Location

Pfizer Investigational Site

Kirkwood, Missouri, 63122, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87108-5154, United States

Location

Pfizer Investigational Site

Mineola, New York, 11501, United States

Location

Pfizer Investigational Site

New York, New York, 10003, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43202, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

Pfizer Investigational Site

Sellersville, Pennsylvania, 18960, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, L8V 1C3, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4G5, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1Y 4E9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

Pfizer Investigational Site

Ste-foy, Quebec, G1V 4G5, Canada

Location

Pfizer Investigational Site

Regina, Saskatchewan, S4P 1Z7, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7L 2W1, Canada

Location

Pfizer Investigational Site

Rotenburg (Wümme), Lower Saxony, D-27356, Germany

Location

Pfizer Investigational Site

Berlin, State of Berlin, D-14109, Germany

Location

Pfizer Investigational Site

Lüdenscheid, D58515, Germany

Location

Pfizer Investigational Site

Maroussi. Attikis, Athens, 15126, Greece

Location

Pfizer Investigational Site

Barcelona, Catalonia, 08036, Spain

Location

Pfizer Investigational Site

Tarrasa, Catalonia, 08221, Spain

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Azithromycin; Ceftriaxone; Levofloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 6, 2002
• Study Start: January 1, 2001
• Study Completion: June 1, 2002
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

US (22); CA (9); DE (3); GR (1); ES (2)