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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01671280
First received: August 20, 2012
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice

Condition Intervention
Pneumonia Pelvic Inflammatory Disease Drug: Azithromycin IV

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Azithromycin Iv

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: 29 days ]
    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.


Secondary Outcome Measures:
  • Clinical Effectiveness Rate in Participants With Pneumonia [ Time Frame: 29 days ]
    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.

  • Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease [ Time Frame: 29 days ]
    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.


Enrollment: 403
Actual Study Start Date: September 20, 2012
Study Completion Date: April 22, 2016
Primary Completion Date: April 22, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Zithromac IV

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involviong A0661207 prescribes the Zithromac IV.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671280

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01671280     History of Changes
Other Study ID Numbers: A0661207
Study First Received: August 20, 2012
Results First Received: March 15, 2017
Last Updated: March 15, 2017

Keywords provided by Pfizer:
pneumonia
pelvic inflammatory disease
Zithromax
Zithromac
Japanese
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Pneumonia
Pelvic Inflammatory Disease
Pelvic Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 27, 2017