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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01671280
Other study ID # A0661207
Secondary ID
Status Completed
Phase N/A
First received August 20, 2012
Last updated February 9, 2017
Start date September 2012
Est. completion date April 2016

Study information

Verified date February 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice


Recruitment information / eligibility

Status Completed
Enrollment 403
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Male or Female patients who are prescribed Zithromac IV for community-acquired pneumonia or pelvic inflammatory disease.

Exclusion Criteria:

- Subjects who have been prescribed Zithromac or ZithromacSR for community-acquired pneumonia or pelvic inflammatory disease.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) by Seriousness and Relationship to Treatment 29 days
Secondary Number of Participants with Clinical Response of Cure at the Test-of-Cure(TOC) Visit 29 days
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