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

• ClinicalTrials.gov Identifier: NCT00998309
• Recruitment Status: Completed
• First Posted: October 20, 2009
• Results First Posted: May 1, 2012
• Last Update Posted: May 1, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Bacterial Infections	Drug: Azithromycin SR

Detailed Description:

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

Study Design

• Study Type: Observational
• Actual Enrollment: 502 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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 Start Date: October 2009
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Groups and Cohorts

Group/Cohort	Intervention/treatment
Azithromycin SR; Patients taking Azithromycin.	Drug: Azithromycin SR; Zithromax SR 2g, taking once for treatment.; Other Name: Zithromax SR, Azithromycin SR

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. [ Time Frame: 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.
2. Number of Participants With Treatment Related Adverse Events (TRAEs) [ Time Frame: 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.
3. Number of Unlisted Treatment Related Adverse Events (TRAEs) [ Time Frame: 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 :

1. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender [ Time Frame: Baseline to 29 days ]
   Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.
2. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age [ Time Frame: Baseline to 29 days ]
   Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.
3. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection [ Time Frame: 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.
4. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity [ Time Frame: 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.
5. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD) [ Time Frame: Baseline to 29 days ]
   Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.
6. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD) [ Time Frame: Baseline to 29 days ]
   Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.
7. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH) [ Time Frame: Baseline to 29 days ]
   Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.
8. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications [ Time Frame: Baseline to 29 days ]
   Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.
9. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH) [ Time Frame: 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.
10. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD) [ Time Frame: Baseline to 29 days ]
    Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
11. Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy [ Time Frame: Baseline to 29 days ]
    Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
12. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender [ Time Frame: 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.
13. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age [ Time Frame: 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.
14. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection [ Time Frame: 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.
15. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity [ Time Frame: 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.
16. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction [ Time Frame: 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.
17. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction [ Time Frame: 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.
18. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History [ Time Frame: 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.
19. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications [ Time Frame: 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.
20. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH) [ Time Frame: 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.
21. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs [ Time Frame: 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.
22. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy [ Time Frame: 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.
23. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The patients whom an involving A0661202 prescribes the Azithromycin SR.

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.

Contacts and Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00998309
• Other Study ID Numbers: A0661202
• First Posted: October 20, 2009
• Results First Posted: May 1, 2012
• Last Update Posted: May 1, 2012
• Last Verified: April 2012

Keywords provided by Pfizer:

skin infection; soft tissue infection; sexually-transmitted infection; infection oral; Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:

Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections; Disease Attributes; Pathologic Processes; Bacterial Infections and Mycoses; Azithromycin; Anti-Bacterial Agents; Anti-Infective Agents