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

Drug Use Investigation Of Azithromycin Iv

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

Study Overview

• Status: Completed
• Conditions: Pneumonia; Pelvic Inflammatory Disease
• Intervention / Treatment: Drug: Azithromycin IV

• Study Type: Observational
• Enrollment (Actual): 403

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involviong A0661207 prescribes the Zithromac IV.

Description

Inclusion Criteria:

• Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Exclusion Criteria:

• Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Azithromycin IV; Subjects who are treated with Azithromycin IV

Drug: Azithromycin IV; The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with 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.; Other Names: Zithromac IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Related Adverse Events	A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Effectiveness Rate in Participants With Pneumonia	Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.	29 days
Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease	Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.	29 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2012
• Primary Completion (ACTUAL): April 22, 2016
• Study Completion (ACTUAL): April 22, 2016

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (ESTIMATE): August 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Japanese; pneumonia; Regulatory Post Marketing Commitment Plan; pelvic inflammatory disease; Zithromax; Zithromac
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Adnexal Diseases; Pneumonia; Pelvic Inflammatory Disease; Pelvic Infection; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: A0661207