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Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

NCT ID: NCT01784770

Last Updated: 2017-11-30

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

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-27

Study Completion Date

2016-07-29

Brief Summary

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To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.

Detailed Description

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Conditions

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Legionnaires' Disease Legionella Pneumophila Infections

Keywords

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Legionnaires' disease Legionella pneumophila Zithromax Zithromac Japanese Regulatory Post Marketing Commitment Plan

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Azithromycin IV

Subjects who are treated with Azithromycin IV for Legionnaires' disease

Azithromycin IV

Intervention Type DRUG

The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.

The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.

Interventions

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Azithromycin IV

The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.

The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.

Intervention Type DRUG

Other Intervention Names

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Zithromac IV

Eligibility Criteria

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Inclusion Criteria

* All patients who are prescribed Azithromycin (Zithromac) IV for Legionnaires' disease.

Exclusion Criteria

* Patients who have been prescribed Zithromac or Zithromac SR.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661208&StudyName=Special%20Investigation%20Of%20Azithromycin%20IV%20For%20Legionnaires%27%20Disease%20%28Regulatory%20Post%20Marketing%20Commitment%20Plan%29

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Other Identifiers

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A0661208

Identifier Type: -

Identifier Source: org_study_id