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.

This study has been completed.

First Received: May 2, 2002 Last Updated: September 2, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00035347

Purpose

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.

Condition	Intervention	Phase
Pneumonia	Drug: IV azithromycin Drug: Ceftriaxone Drug: Azithromycin tablets Drug: IV levofloxacin Drug: Levofloxacin tablets	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone Sodium Ofloxacin Azithromycin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Enrollment:	360
Study Start Date:	January 2001
Study Completion Date:	June 2002
Primary Completion Date:	June 2002 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035347

Show 35 Study Locations

Sponsors and Collaborators

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661035
Study First Received:	May 2, 2002
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00035347 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pneumonia
Chest infection
Anti-infectives
Antibiotics

Study placed in the following topic categories:

Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin
Lung Diseases

Ofloxacin
Anti-Infective Agents, Urinary
Ceftriaxone
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Ceftriaxone
Renal Agents
Pharmacologic Actions

Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Azithromycin
Therapeutic Uses
Pneumonia
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009