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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00998309
First received: October 16, 2009
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Bacterial Infections
Drug: Azithromycin SR

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: Yes ]
    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:
  • Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 29 days ] [ Designated as safety issue: No ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.


Enrollment: 502
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Azithromycin SR
Patients taking Azithromycin.
Drug: Azithromycin SR
Zithromax SR 2g, taking once for treatment.
Other Name: Zithromax SR, Azithromycin SR

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998309

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00998309     History of Changes
Other Study ID Numbers: A0661202
Study First Received: October 16, 2009
Results First Received: January 12, 2012
Last Updated: April 2, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Pfizer:
skin infection
soft tissue infection
sexually-transmitted infection
infection oral
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection
Sexually Transmitted Diseases
Soft Tissue Infections
Genital Diseases, Female
Genital Diseases, Male
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014