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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	IV azithromycin	500 mg once daily
DRUG	ceftriaxone	1 gram once daily for 2 to 5 days
DRUG	oral azithromycin	2 x 250 mg once daily
DRUG	IV levofloxacin	500 mg once daily
DRUG	oral levofloxacin	500 mg once daily

Timeline

• Start date: 2001-01-01
• Completion: 2002-06-01
• First posted: 2002-05-06
• Last updated: 2017-03-10

Locations

37 sites across 5 countries: United States, Canada, Germany, Greece, Spain