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Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

NCT ID: NCT01032694

Last Updated: 2011-12-21

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

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice.

Detailed Description

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Conditions

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Community-Acquired Pneumonia

Keywords

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Community-Acquired Pneumonia Azithromycin SR Amoxiclav

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Z-max treated group

Patients with Community-Acquired Pneumonia

Azithromycin SR

Intervention Type DRUG

Azithromycin SR, 2.0 g PO x 1 dose for treatment period

Amoxiclav treated group

Patients with Community-Acquired Pneumonia

Amoxiclav

Intervention Type DRUG

Amoxiclav 1000 x twice daily, 10 days duration

Interventions

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Azithromycin SR

Azithromycin SR, 2.0 g PO x 1 dose for treatment period

Intervention Type DRUG

Amoxiclav

Amoxiclav 1000 x twice daily, 10 days duration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:

1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
2. Body temperature \>38 degrees C.

Exclusion Criteria

* Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.
* Amoxiclav according to LPDs, pregnant or lactating women.
Minimum Eligible Age

18 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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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=A0661200&StudyName=Non-Interventional%20Open%20Label%20Prospective%20Observational%20Comparative%20Study%20On%20Evaluation%20Of%20Compliance%20Of%20The%20Empiric%20Treatment%20With%20Azithromyc

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Other Identifiers

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A0661200

Identifier Type: -

Identifier Source: org_study_id