Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)

Community-acquired Pneumonia Clinical Trial

— RESCUE  

Official title:

Drug Use Investigation Of Azithromycin Iv

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671280
• Other study ID #: A0661207
• 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
• 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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pelvic Inflammatory Disease
• Pneumonia

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

External Links

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