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Completed

NCT Number: NCT00998309

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin SR

Drug

Zithromax SR 2g, taking once for treatment.

Other names: Zithromax SR, Azithromycin SR

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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