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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01671280
First received: August 20, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Community-acquired Pneumonia
Pelvic Inflammatory Disease
Drug: Azithromycin IV
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Research Of Effectiveness And Safety On Patients With Pneumonia And PID, Continuous Treatment With Azithromycin IV And Tab Utilized As The First Administrative Evaluation (RESCUE)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants with Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Clinical Response of Cure at the Test-of-Cure(TOC) Visit [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 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 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.

Other Name: Zithromac IV

  Eligibility

Genders Eligible for Study:   Both
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 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.
  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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01671280     History of Changes
Other Study ID Numbers: A0661207
Study First Received: August 20, 2012
Last Updated: August 21, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
community-acquired 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
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014