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

Phase 4

Completed

• Conditions: Community-Acquired Pneumonia (CAP)
• Interventions: Drug: IV azithromycin; Drug: IV levofloxacin; Drug: oral levofloxacin; Drug: ceftriaxone; Drug: oral azithromycin

• Registration Number: NCT00035347
• Lead Sponsor: Pfizer

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

Not available

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Study Completion: 2002-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin plus ceftriaxone group (AZY+CEF group)	oral azithromycin	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
Levofloxacin group (LEV group)	oral levofloxacin	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.
Azithromycin plus ceftriaxone group (AZY+CEF group)	ceftriaxone	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
Azithromycin plus ceftriaxone group (AZY+CEF group)	IV azithromycin	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
Levofloxacin group (LEV group)	IV levofloxacin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Tarrasa, Cataluna, Spain