Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
Intervention: Azithromycin SR (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.Number of Participants With Treatment Related Adverse Events (TRAEs) Number of Unlisted Treatment Related Adverse Events (TRAEs)
Secondary outcome: Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-GenderRisk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female
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
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2009
Last updated: April 2, 2012
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