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
NCT00035347 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219
Last updated 2017-03-10
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
- DRUG
-
IV azithromycin
500 mg once daily
- DRUG
-
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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-01-31
- Completion
- 2002-06-30
Countries
- United States
- Canada
- Germany
- Greece
- Spain
Study Locations
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