The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
NCT ID: NCT00809328
Last Updated: 2011-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
2009-02-28
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azithromycin
Azithromycin switch therapy (switch from intravenous to oral)
Azithromycin
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
Interventions
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Azithromycin
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
Eligibility Criteria
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Inclusion Criteria
* Patients who were diagnosed as moderate in severity.
Exclusion Criteria
* Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
* Severe renal dysfunction (creatinine clearance \< 30 ml/min).
* Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
* Severe underlying disease.
16 Years
80 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Seto-shi, Aichi-ken, Japan
Pfizer Investigational Site
Touon, Ehime, Japan
Pfizer Investigational Site
Chikushino-shi, Fukuoka, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Koga, Fukuoka, Japan
Pfizer Investigational Site
Yanagawa, Fukuoka, Japan
Pfizer Investigational Site
Higashihiroshima, Hiroshima, Japan
Pfizer Investigational Site
Hiroshima, Hiroshima, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Pfizer Investigational Site
Himejishi, Hyōgo, Japan
Pfizer Investigational Site
Moriya, Ibaraki, Japan
Pfizer Investigational Site
Kanazawa, Ishikawa-ken, Japan
Pfizer Investigational Site
Takamatsu, Kagawa-ken, Japan
Pfizer Investigational Site
Kawasaki, Kanagawa, Japan
Pfizer Investigational Site
Kochi, Kochi, Japan
Pfizer Investigational Site
Tsu, Mie-ken, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Matsumoto, Nagano, Japan
Pfizer Investigational Site
Emukae, Kitamatsuura, Nagasaki, Japan
Pfizer Investigational Site
Isahaya, Nagasaki, Japan
Pfizer Investigational Site
Nagasaki, Nagasaki, Japan
Pfizer Investigational Site
Sasebo, Nagasaki, Japan
Pfizer Investigational Site
Niigata, Niigata, Japan
Pfizer Investigational Site
Ōita, Oita Prefecture, Japan
Pfizer Investigational Site
Yufu, Oita Prefecture, Japan
Pfizer Investigational Site
Kurashiki, Okayama-ken, Japan
Pfizer Investigational Site
Okinawa, Okinawa, Japan
Pfizer Investigational Site
Sakai, Osaka, Japan
Pfizer Investigational Site
Ureshinoshi, Saga-ken, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Meguro-Ku, Tokyo, Japan
Pfizer Investigational Site
Toshima-ku, Tokyo, Japan
Pfizer Investigational Site
Yonezawa, Yamagata, Japan
Pfizer Investigational Site
Shiogama, , Japan
Countries
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References
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Kohno S, Tateda K, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0661191
Identifier Type: -
Identifier Source: org_study_id
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