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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 2, 2002 |
| Last Updated Date | September 2, 2008 |
| Start Date ICMJE | January 2001 |
| Primary Completion Date | June 2002 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00035347 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | 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 ICMJE | |
| 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. |
| Detailed Description | |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Pneumonia |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 360 |
| Completion Date | June 2002 |
| Primary Completion Date | June 2002 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada, Germany, Greece, Spain |
| Administrative Information | |
| NCT ID ICMJE | NCT00035347 |
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| Study ID Numbers ICMJE | A0661035 |
| Study Sponsor ICMJE | Pfizer |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Pfizer |
| Verification Date | September 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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