The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

NCT ID: NCT00809328

Last Updated: 2011-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-03-31

Brief Summary

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Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.

Detailed Description

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Conditions

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Community Acquired Pneumonia (CAP)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin

Azithromycin switch therapy (switch from intravenous to oral)

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 16 years of age or older patients with CAP.
* Patients who were diagnosed as moderate in severity.

Exclusion Criteria

* Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

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

Site Status

Pfizer Investigational Site

Touon, Ehime, Japan

Site Status

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Koga, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Yanagawa, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Higashihiroshima, Hiroshima, Japan

Site Status

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Site Status

Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Himejishi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Moriya, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Pfizer Investigational Site

Takamatsu, Kagawa-ken, Japan

Site Status

Pfizer Investigational Site

Kawasaki, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Kochi, Kochi, Japan

Site Status

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Site Status

Pfizer Investigational Site

Sendai, Miyagi, Japan

Site Status

Pfizer Investigational Site

Matsumoto, Nagano, Japan

Site Status

Pfizer Investigational Site

Emukae, Kitamatsuura, Nagasaki, Japan

Site Status

Pfizer Investigational Site

Isahaya, Nagasaki, Japan

Site Status

Pfizer Investigational Site

Nagasaki, Nagasaki, Japan

Site Status

Pfizer Investigational Site

Sasebo, Nagasaki, Japan

Site Status

Pfizer Investigational Site

Niigata, Niigata, Japan

Site Status

Pfizer Investigational Site

Ōita, Oita Prefecture, Japan

Site Status

Pfizer Investigational Site

Yufu, Oita Prefecture, Japan

Site Status

Pfizer Investigational Site

Kurashiki, Okayama-ken, Japan

Site Status

Pfizer Investigational Site

Okinawa, Okinawa, Japan

Site Status

Pfizer Investigational Site

Sakai, Osaka, Japan

Site Status

Pfizer Investigational Site

Ureshinoshi, Saga-ken, Japan

Site Status

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Meguro-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Yonezawa, Yamagata, Japan

Site Status

Pfizer Investigational Site

Shiogama, , Japan

Site Status

Countries

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Japan

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.

Reference Type DERIVED
PMID: 24477328 (View on PubMed)

Related Links

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Other Identifiers

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A0661191

Identifier Type: -

Identifier Source: org_study_id

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