Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
Intervention: Azithromycin SR (Zithromax SR) (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
To collect the efficacy and safety information of Zithromax-SR related to their appropriate
use in daily practice.
Clinical Details
Official title: Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)
Study design: Case-Only, Prospective
Primary outcome: The frequency of treatment related adverse events.Risk factors likely to affect the frequency of treatment related adverse events. Unlisted treatment related adverse events.
Secondary outcome: The proportion of responders to azithromycin-SR treatment.Risk factors likely to affect the proportion of responders.
Detailed description:
All the patients whom an investigator prescribes the first Azithromycin SR should be
registered within 14 days.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female subjects diagnosed with skin and soft tissue infection,
sexually-transmitted infection, and infection of the oral.
- Subjects must have no prior experience with Azithromycin SR.
Exclusion Criteria:
- Patients not administered Azithromycin SR.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2009
Ending date: December 2011
Last updated: October 19, 2009
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