Clinical trial NCT00035347: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-Acquired Pneumonia (CAP)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Duration of trial
Secondary outcomes:
measure: 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.
timeFrame: Duration of trial
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Sylmar
country: United States
facility: Pfizer Investigational Site
state: California
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Ft Gordon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Shawnee Mission
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kirkwood
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Rotenburg (wuemme)
country: Germany
facility: Pfizer Investigational Site
state: Niedersachsen
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Luedenscheid
country: Germany
facility: Pfizer Investigational Site
city: Maroussi. Attikis
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
state: Cataluna
city: Tarrasa
country: Spain
facility: Pfizer Investigational Site
state: Cataluna
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: