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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Community-Acquired Pneumonia (CAP)

Intervention / Treatment
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* Drug: IV azithromycin
* Drug: ceftriaxone
* Drug: oral azithromycin
* Drug: IV levofloxacin
* Drug: oral levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion 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. Exclusion Criteria: Pregnant women, nursing mothers, or women of childbearing potential not practicing adequate contraception. Known or suspected hypersensitivity or intolerance to any quinolone, penicillin, cephalosporin, or macrolide antibiotic. Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to the baseline visit. Subjects with clinically significant renal dysfunction. Subjects with clinically significant hepatic dysfunction. Subjects with clinically significant cardiovascular disorders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin plus ceftriaxone group (AZY+CEF group)<br>IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy | Drug: IV azithromycin<br>* 500 mg once daily<br>* Other names: Zithromax®;Drug: ceftriaxone<br>* 1 gram once daily for 2 to 5 days<br>* Other names: Rocephin®;Drug: oral azithromycin<br>* 2 x 250 mg once daily<br>* Other names: Zithromax®;|
| Experimental: Levofloxacin group (LEV group)<br>IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy. | Drug: IV levofloxacin<br>* 500 mg once daily<br>* Other names: Levaquin®;Drug: oral levofloxacin<br>* 500 mg once daily<br>* Other names: Levaquin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia. |  | Duration of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen. |  | Duration of trial |