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
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| ClinicalTrials.gov Identifier: NCT00035347 |
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Recruitment Status :
Completed
First Posted : May 6, 2002
Last Update Posted : March 10, 2017
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Sponsor:
Pfizer
Information provided by:
Pfizer
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Community-Acquired Pneumonia (CAP) | Drug: IV azithromycin Drug: ceftriaxone Drug: oral azithromycin Drug: IV levofloxacin Drug: oral levofloxacin | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 219 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | January 2001 |
| Actual Study Completion Date : | June 2002 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pneumonia
| Arm | Intervention/treatment |
|---|---|
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Experimental: Azithromycin plus ceftriaxone group (AZY+CEF group)
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
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Drug: IV azithromycin
500 mg once daily
Other Name: Zithromax® Drug: ceftriaxone 1 gram once daily for 2 to 5 days
Other Name: Rocephin® Drug: oral azithromycin 2 x 250 mg once daily
Other Name: Zithromax® |
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Experimental: Levofloxacin group (LEV group)
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.
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Drug: IV levofloxacin
500 mg once daily
Other Name: Levaquin® Drug: oral levofloxacin 500 mg once daily
Other Name: Levaquin® |
Primary Outcome Measures :
- 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. [ Time Frame: Duration of trial ]
Secondary Outcome Measures :
- 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. [ Time Frame: Duration of trial ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035347
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90822 | |
| Pfizer Investigational Site | |
| Sylmar, California, United States, 91342 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Sarasota, Florida, United States, 34339 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Columbus, Georgia, United States, 31902 | |
| Pfizer Investigational Site | |
| Columbus, Georgia, United States, 31904 | |
| Pfizer Investigational Site | |
| Ft Gordon, Georgia, United States, 30905 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Shawnee Mission, Kansas, United States, 66204 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40206 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| Pfizer Investigational Site | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Kirkwood, Missouri, United States, 63122 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Mexico | |
| Pfizer Investigational Site | |
| Albuquerque, New Mexico, United States, 87108-5154 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Mineola, New York, United States, 11501 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Winston-salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43202 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pfizer Investigational Site | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4G5 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Pfizer Investigational Site | |
| Ste-foy, Quebec, Canada, G1V 4G5 | |
| Canada, Saskatchewan | |
| Pfizer Investigational Site | |
| Regina, Saskatchewan, Canada, S4P 1Z7 | |
| Pfizer Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7L 2W1 | |
| Germany | |
| Pfizer Investigational Site | |
| Rotenburg (wuemme), Niedersachsen, Germany, D-27356 | |
| Pfizer Investigational Site | |
| Berlin, Germany, D-14109 | |
| Pfizer Investigational Site | |
| Luedenscheid, Germany, D58515 | |
| Greece | |
| Pfizer Investigational Site | |
| Maroussi. Attikis, Athens, Greece, 15126 | |
| Spain | |
| Pfizer Investigational Site | |
| Barcelona, Cataluna, Spain, 08036 | |
| Pfizer Investigational Site | |
| Tarrasa, Cataluna, Spain, 08221 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00035347 |
| Other Study ID Numbers: |
A0661035 |
| First Posted: | May 6, 2002 Key Record Dates |
| Last Update Posted: | March 10, 2017 |
| Last Verified: | March 2017 |
Additional relevant MeSH terms:
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Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Azithromycin Levofloxacin Ofloxacin Ceftriaxone Anti-Bacterial Agents |
Anti-Infective Agents Anti-Infective Agents, Urinary Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |