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: March 21, 2014
Last verified: March 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
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: March 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 April 14, 2014