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 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...

Date First Received: May 2, 2002

Last Updated: September 2, 2008

Verified by: Pfizer, September 2008

Clinical Trial Phase: Phase 4 | Start Date: January 2001

Overall Status: Completed

Estimated Enrollment: 360

Brief Summary

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2002

Intervention(s) in this Clinical Trial

  • Drug: IV azithromycin
  • Drug: Ceftriaxone
  • Drug: Azithromycin tablets
  • Drug: IV levofloxacin
  • Drug: Levofloxacin tablets

Criteria for Participation in this Clinical Trial

  • 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Pfizer

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00035347

Study ID Number: A0661035

ClinicalTrials.gov Identifier: NCT00035347

Health Authority: United States: Food and Drug Administration

Link to ClinicalStudyResults.org Posting

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