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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)-Gender

Risk 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

Page last updated: August 23, 2015

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