- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998309
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
April 2, 2012 updated by: Pfizer
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.
Study Overview
Detailed Description
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
Study Type
Observational
Enrollment (Actual)
502
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The patients whom an involving A0661202 prescribes the Azithromycin SR.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Azithromycin SR
Patients taking Azithromycin.
|
Zithromax SR 2g, taking once for treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
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.
|
Baseline to 29 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
October 16, 2009
First Submitted That Met QC Criteria
October 19, 2009
First Posted (Estimate)
October 20, 2009
Study Record Updates
Last Update Posted (Estimate)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 2, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0661202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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