Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: Azithromycin SR

• Registration Number: NCT00998309
• Lead Sponsor: Pfizer

Brief Summary

To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.

Detailed Description

All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-01-12
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-02
• Last Update Submitted: 2012-04-02
• Results First Posted: 2012-05-01
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azithromycin SR	Azithromycin SR	Patients taking Azithromycin.

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.	Baseline to 29 days	The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.
Number of Participants With Treatment Related Adverse Events (TRAEs)	Baseline to 29 days	All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Number of Unlisted Treatment Related Adverse Events (TRAEs)	Baseline to 29 days	All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.

Secondary Outcome Measures

Name	Time	Method
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether type of infection, "Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection", is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether Infection severity, "mild infection, moderate infection, or severe infection", is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy	Baseline to 29 days	Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, "Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection", is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female	Baseline to 29 days	Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.