Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)
NCT01671280
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.
- Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory
disease.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) | |||
| Official Title | Drug Use Investigation Of Azithromycin Iv | |||
| Brief Summary | To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients whom an investigator involviong A0661207 prescribes the Zithromac IV. | |||
| Condition |
| |||
| Intervention | 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 | |||
| Study Groups/Cohorts | Azithromycin IV
Subjects who are treated with Azithromycin IV Intervention: Drug: Azithromycin IV | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 403 | |||
| Original Estimated Enrollment | 400 | |||
| Actual Study Completion Date | April 22, 2016 | |||
| Actual Primary Completion Date | April 22, 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01671280 | |||
| Other Study ID Numbers | A0661207 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2017 | |||