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

October 16, 2009
April 2, 2012
October 2009
January 2011   (final data collection date for primary outcome measure)
  • 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.
  • Unlisted treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • The frequency of treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00998309 on ClinicalTrials.gov Archive Site
  • 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.
  • The proportion of responders to azithromycin-SR treatment. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Risk factors likely to affect the proportion of responders. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)

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

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The patients whom an involving A0661202 prescribes the Azithromycin SR.

Bacterial Infections
Drug: Azithromycin SR
Zithromax SR 2g, taking once for treatment.
Other Name: Zithromax SR, Azithromycin SR
Azithromycin SR
Patients taking Azithromycin.
Intervention: Drug: Azithromycin SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
502
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00998309
A0661202
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP