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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Community-Acquired Pneumonia

Intervention: Azithromycin SR (Drug); Amoxiclav (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

Official title: 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

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: Percentage of Participants With Response of Very Convenient or Somewhat Convenient

Secondary outcome:

Percent Compliance With the Prescribed Treatment Regimen

Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2010
Last updated: November 21, 2011

Page last updated: August 23, 2015

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