Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) (RESCUE)
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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) |
- Number of Participants with Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
- 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 |
The patients whom an investigator involviong A0661207 prescribes the Zithromac IV.
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 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: | May 28, 2013 |
| 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 |
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 June 18, 2013