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

Community-Acquired Pneumonia (CAP) Clinical Trial

Official title:

A Randomized, Multicenter, Open Label Trial Comparing Intravenous Zithromax® (Azithromycin) Plus Intravenous Rocephin® (Ceftriaxone) Followed By Oral Zithromax® (Azithromycin) With Intravenous Levaquin® (Levofloxacin) Followed By Oral Levaquin® (Levofloxacin) For The Treatment Of Moderate To Severely Ill Hospitalized Subjects With Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035347
• Other study ID #: A0661035
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2002
• Last updated: March 7, 2017
• Start date: January 2001
• Est. completion date: June 2002

Study information

• Verified date: March 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community-Acquired Pneumonia (CAP)
• Pneumonia

Intervention

Drug:
• IV azithromycin
500 mg once daily
• ceftriaxone
1 gram once daily for 2 to 5 days
• oral azithromycin
2 x 250 mg once daily
• IV levofloxacin
500 mg once daily
• oral levofloxacin
500 mg once daily

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Regina	Saskatchewan
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Ste-foy	Quebec
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Luedenscheid
Germany	Pfizer Investigational Site	Rotenburg (wuemme)	Niedersachsen
Greece	Pfizer Investigational Site	Maroussi. Attikis	Athens
Spain	Pfizer Investigational Site	Barcelona	Cataluna
Spain	Pfizer Investigational Site	Tarrasa	Cataluna
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Georgia
United States	Pfizer Investigational Site	Columbus	Georgia
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Ft Gordon	Georgia
United States	Pfizer Investigational Site	Kirkwood	Missouri
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Royal Oak	Michigan
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Shawnee Mission	Kansas
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Sylmar	California
United States	Pfizer Investigational Site	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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