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

Bacterial Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998309
• Other study ID #: A0661202
• Status: Completed
• Phase: N/A
• First received: October 16, 2009
• Last updated: April 2, 2012
• Start date: October 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Infection
• Sexually Transmitted Diseases
• Soft Tissue Infections

Intervention

Drug:
• Azithromycin SR
Zithromax SR 2g, taking once for treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.	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	No
Primary	Number of Participants With Treatment Related Adverse Events (TRAEs)	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	Yes
Primary	Number of Unlisted Treatment Related Adverse Events (TRAEs)	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	Yes
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender	Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age	Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection	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	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity	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	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)	Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)	Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)	Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications	Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)	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	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)	Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy	Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.	Baseline to 29 days	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy	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	No
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female	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	No

External Links

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